HODGKIN'S LYMPHOMA



HODGKIN'S LYMPHOMA

Epidemiology

( US incidence = 7,500 cases/yr

3 per 100,000 people

< 1% of all cancers

( 15% of all lymphomas

( 1.3 male : 1 female

1.8 white : 1 black

( age: rare in those < 10 yr

median age = 26 yr

bimodal peak – 20’s (large peak) & > 50 yr (smaller peak)

Risk Factors

( no well defined risk factors

Relative Risk

( same-sex sibling with Hodgkin's disease 9.0

opposite-sex sibling with Hodgkin's disease 3.0

( h/o mononucleosis (EBV) 2.5

possible association with EBV infection, especially with mixed cellularity subtype -- can see high anti-EBV titers

( possible association with immunosuppression:

HIV - associated with advanced stage at presentation, systemic symptoms, & unusual pattern of involvement

transplant recipients

( increased educational level / socioeconomic status ?

( s/p tonsillectomy or appendectomy ?

Pathology

( Reed-Sternberg cell

- binucleate, prominent nucleolus, well-demarcated nuclear membrane, eosinophilic cytoplasm, perinuclear halo

- arise from germinal center or post-germinal center B-cells

- CD30+, CD15+, CD45(LCA)-, CD20-

o CD45 may be most important b/c usually + in NHL and – in HD (7% may be + in HD)

- has NF(B DNA binding activity - NF(B induces anti-apoptotic effects

( RYE Classification:

Nodular Sclerosis 65%

Mixed Cellularity 20%

Lymphocyte Predominant 10%

nodular subtype (majority)

diffuse subtype

Lymphocyte Depleted 5%

( REAL Classification:

Classic Hodgkin's Disease (95%):

Classic Lymphocyte Predominant

classic Reed-Sternberg cells – CD45-, CD20-

Nodular Sclerosis

Mixed Cellularity

Lymphocyte Depletion

Nodular Lymphocyte Predominant (5%)

scarce Reed-Sternberg cells – CD45+, CD20+ (( Rituxin may be useful)

frequent "popcorn cell" variants

background of B-lymphocytes

( Lymphocyte Predominance Hodgkin's Disease (LPHD):

Nodular Subtype:

- abundant normal-appearing lymphocytes

- scarce atypical mononuclear cells

- absence of classic Reed-Sternberg cells

- "popcorn cells": CD20+, CD45+, CD15-, CD30-

- nodular growth pattern +/- diffuse areas

- +/- progressive transformation of germinal centers (PTGCs) = enlarged follicles than contain numerous small

B cells of mantle zone type (may precede the development of this form of Hodgkin's disease)

- Incidence is evenly distributed among all ages

- 75% are early stage I an II

- Much less involvement of the mediastinum

- Rare to be Lap+ if Stage 1 Disease involving cervical, axillary, femoral LN

Diffuse Subtype:

- abundant normal-appearing lymphocytes

- classic Reed-Sternberg cells

- Acts more like HD than nodular subtype

( Nodular Sclerosis Hodgkin's Disease (NSHD):

- most common type in US

- broad bands of birefringent collagen (fibrotic nodes) surrounding macroscopic nodules consisting of

lymphocytes, eosinophils, plasma cells, histiocytes, atypical mononuclear cells, & Reed-Sternberg cells

- lacunar-type Reed-Sternberg cells (clear spaces are 2(/2 formalin fixation artifact)

- necrosis is commonly seen

- Usually involves the mediastinum/lower cervical LN

- Can be divided into

1. NSLP

2. NS Mixed Cell

3. NS Lymph depleted

• But all act with same outcomes

( Mixed Cellularity Hodgkin's Disease (MCHD):

- diffuse effacement of lymph nodes by lymphocytes, neutrophils, histiocytes, eosinophils, plasma cells, &

abundant atypical mononuclear and Reed-Sternberg cells

- Usually older pts with B symptoms

- Often have abdominal involvement

( Lymphocyte Depletion Hodgkin's Disease (LDHD):

- least common type is US

- paucity of normal-appearing lymphocytes

- abundance of abnormal mononuclear cells, Reed-Sternberg cells, & Reed-Sternberg cell variants

- diffuse fibrosis and necrosis

- With most modern techniques, most of these cases are really found to be NHL

- Most frequently found in ederly pt with advanced disease

Staging

( Ann Arbor Staging System:

stage I involvement of a single lymph node region

IE involvement of a single extralymphatic organ or site

stage II involvement of a two or more lymph node regions on the same side of the diaphragm

IIE involvement of a single extralymphatic organ or site and its regional nodes +/- other lymph node

regions on the same side of the diaphragm

stage III involvement of lymph node regions on both sides of the diaphragm

IIIE involvement of a single extralymphatic organ or site and lymph node regions on both sides of the

diaphragm

IIIS involvement of the spleen and lymph node regions on both sides of the diaphragm

IIIE+S involvement of a single extralymphatic organ or site, the spleen, and lymph node regions on both

sides of the diaphragm

stage IV involvement of multiple extralymphatic organs +/- associated lymph

node involvement or involvement of a single extralymphatic organ

with distant / nonregional lymph node involvement

( A no B symptoms

B unexplained weight loss > 10% in the 6 mo preceding diagnosis

unexplained fever > 38(C for 3 consecutive days

drenching night sweats

limitations of Ann Arbor staging system: bulky disease is not taken into account

no distinction between minimal (< 5 nodules) or extensive splenic dz

( Lymphoid Structures not considered as E-lesions:

Waldeyer's ring

thymus

spleen

appendix

Peyer's patches (ileum)

( Lymphoid Regions Defined by the Ann Arbor Staging System:

Waldeyer's ring (palatine tonsil, base of tongue / lingual tonsil, nasopharynx / adenoids)

Neck = Cervical, Supraclavicular, Occipital, & Pre-auricular

Infraclavicular

Mediastinal

Hilar

Axillary

Epitrochlear / Brachial

Paraaortic

Spleen

Mesenteric

Iliac

Inguinal / Femoral

Popliteal

( Cotswold's Modification of the Ann Arbor Staging System:

stage I involvement of a single lymph node region or lymphoid structure (spleen, thymus, Waldeyer's ring)

IE involvement of a single extralymphatic organ or site

stage II involvement of a two or more lymph node regions on the same side of the diaphragm

IIE involvement of a single extralymphatic organ or site and its regional nodes +/- other lymph node

regions on the same side of the diaphragm

stage III involvement of lymph node regions on both sides of the diaphragm

III1 with or without involvement of splenic, hilar, celiac, or portal nodes (above renal vein)

III2 with involvement of paraaortic, iliac, and mesenteric nodes (below renal vein)

IIIE involvement of a single extralymphatic organ or site and lymph node regions on both sides of the

diaphragm

IIIS involvement of the spleen and lymph node regions on both sides of the diaphragm

IIISE involvement of a single extralymphatic organ or site, the spleen, and lymph node regions on both

sides of the diaphragm

stage IV diffuse or disseminated involvement of one or more extranodal organs or tissues, with or without

associated lymph node involvement

( A no B symptoms

B unexplained weight loss > 10% in the 6 mo preceding diagnosis

unexplained fever > 38(C for 3 consecutive days

drenching night sweats

E involvement of a single extranodal site that is contiguous or proximal to the known nodal site

X bulky disease -- nodal mass > 10 cm in maximal dimension (many consider > 5 cm peripheral mass)

mediastinal widening > 1/3 thoracic width at T5/6 on PA up-right CxR

CS clinical stage

PS pathological stage

PS III1 = limited to the upper abdomen (splenic, hilar, celiac, & portahepatic nodes)

PS III2 = involvement of paraaortic, mesenteric, or pelvic nodes

PS IIIS + minimal = < 5 visible nodules in the spleen

PS IIIS + extensive = > 5 visible nodules in the spleen

• Note Mediastinum considered one site

• Hilar LN Considered Lateralized site

• Liver involvement includes

1. Either enlargement of liver and at least an abnl Alk Phos and 2 different LFTs abnl

2. Abnl Liver on imaging and one abnl liver LFT

Presentation

( symptoms/signs:

- painless lymphadenopathy (80%): firm or rubbery, mobile, non-tender nodes

- systemic symptoms: 15-20% of stage I-II cases

B-symptoms = unexplained fever > 38( x 3 d (classic waxing & waning Pel-Ebstein pattern)

drenching night sweats

weight loss > 10% in preceding 6 mo

generalized pruritus

alcohol-induced pain in tissues involved by Hodgkin's disease (~ 10% ??)

- mediastinal mass on CxR +/- cough, wheezing, dyspnea, SVC syndrome(rare)

- complex deficiency in cellular immunity:

- Paraneoplastic effects include

o Increased Eosinophils

o Increased Platelets (may herald relapse if present prior to therapy)

o Autoimmune anemia

o Nephrotic Syndrome

( DDx of adenopathy:

infectious – usually soft, tender, < 2 cm

located in areas that drain common infections (anterior or posterior cervical nodes)

ex. common communicable diseases, mono (EBV), CMV, HIV/AIDS, syphilis, TB

hypersensitivity reactions – serum sickness, drug pseudolymphoma

connective tissue disease – SLE, RA

primary lymphoproliferative diseases – HD, NHL, leukemia (CLL, ALL, blast crisis of CML),

Waldenstrom’s macroglobinemia

metastatic carcinomas – breast, lung, GI, H&N, skin, …

endocrine disorders – hyperthyroidism, hypoadrenocorticism, hypopituitarism

lipidoses

dermatopathic lymphadenitis

granulomatous disease – sarcoidosis

drugs – phenytoin, isoniazid, antithyroid, anti-leprosy drugs

( location:

- > 80% present with cervical lymph node involvement

- > 50% have mediastinal disease (young adults > elderly)

- 25% of elderly have isolated subdiaphragmatic disease at diagnosis (only ~ 10% overall)

- isolated extralymphatic involvement is rare

- #1 extranodal site = spleen

- 5% have BM involvement – almost always associated with extensive disease & B symptoms

- 2-6% have liver involvement – almost always occurs with concomitant splenic involvement

- rarely involves GALT, MALT, CNS, or skin

- rarely involves Waldeyer’s ring

supradiaphragmatic 90%

|nodal region | |prevalence (%) |

|mediastinum | |59% |

|neck | |70% |

| |left |58% |

| |right |55% |

|axilla | |27% |

| |left |14% |

| |right |13% |

|hilum | |23% |

| |left |12% |

| |right |11% |

|upper neck | |5% |

|infraclavicular | |3% |

|epitrochlear | |2% |

|cardiac | |1% |

subdiaphragmatic 25%

|nodal region |prevalence (%) |

|spleen |25% |

|liver |3% |

|paraaortic | |

|iliac | |

|inguinofemoral | |

|popliteal | |

|mesenteric | |

|Peyer's patches | |

|appendix | |

( PM Mauch, et al. Cancer. 71:2062-2071, 1993. - Joint Center

analyzed pattern of nodal involvement in 719 pt with HD who underwent staging lap between '69-'86

positive associations: mediastinum ( hilum and neck

ipsilateral neck ( ipsilateral axilla (75 / 398)

axilla ( upper abdomen

hilum ( upper abdomen (Also shown by the German HD group)

spleen ( upper abdomen and lower abdomen

| |LPHD |NSHD |MCHD |LDHD |

|distribution |5% |78% |16% |1% |

|median age |30 yr |26 yr |30 yr |38 yr |

|Male:female ratio |5.3:1 |1.1:1 |3.9:1 |2:1 |

|Stage: I |45% |6% |13% |0% |

| II |37% |53% |28% |13% |

| III |16% |29% |44% |33% |

| IV |1% |12% |15% |53% |

|B symptoms |2% |30% |31% |60% |

Stanford Experience with 2,116 pt treated between '68-'96

Work-up

( history:

adenopathy, B symptoms (30% to 40%), alcohol intolerance, pruritus, energy loss, respiratory problems

( physical exam:

nodal chains, size of liver & spleen, Waldeyer's ring, bony tenderness

( laboratory studies:

CBC (often see a mild pancytopenia 2(/2 paraneoplastic effect) Anemia also possible

lytes, BUN/Cr

LFTs (alk phos = nonspecific marker of tumor activity or hepatic, BM, or bone involvement)

LDH (may reflect tumor burden)

ESR & serum copper (may correlate with disease activity)

(2-microglobulin

( radiographic studies:

CxR (60% will have evidence of intrathoracic involvement)

CT chest / abd / pelvis (info on chest CT alters the RT plan in ~ 15%)

- 70% sensitivity for paraaortic nodes & 30% for pelvic nodes

- 92% specificity for paraaortic nodes

- 58% accuracy for spleen

PET scan

- 18F-FDG (18F-fluorodeoxyglucose)

- may be more sensitive than Gallium scan

- especially important for NSHD

- useful in assessing residual masses on CT scan after chemo ( if (+), 60-90% relapse with observation

- Up to 20% of adults with – PET and residual mass will eventually have a relapse

Weihrauch, et al. Blood. 98:2930-2934, 2001. – Germany

prospective study

29 pt with HD and residual mediastinal mass > 2 cm after chemo underwent 18FDG-PET between 1994-2000

minimum f/u = 1 yr

median f/u = 28 mo

all (+)PET scans showed only uptake in the mediastinum

|PET scan result |relapse rate |1-yr DFS rate |

|negative (n=19) |16% |95% |

|positive (n=10) |60% |40% |

PPV = 60%

NPV = 95%

all relapsing pt with (+)PET scan relapsed in the mediastinum only

conclusions = pt with a residual mass after chemo but (-)PET are unlikely to relapse & can be observed

Mikhaeel, et al. Ann Oncol. 1:147-150, 2000. – UK

32 pt with residual mediastinal mass > 2 cm after chemo (15 HD, 17 NHL) underwent 18FDG-PET

median f/u = 38 mo

|PET scan result | |relapse rate |

|negative (n=23) |HD (n=11) |0% |

| |NHL (n=12) |17% |

|positive (n=9) |HD (n=4) |75% |

| |NHL (n=5) |100% |

Naumann, et al. Br J Haematol. 115:793-800, 2001. – Germany

58 pt with residual mediastinal mass > 1 cm after chemo (43 HD, 15 NHL) underwent 18FDG-PET

median f/u = 36 mo

HD – all (+)PET scans showed only uptake in the mediastinum

|PET scan result | |relapse rate |

|negative – SUV < 3 (n=50) |HD (n=39) |0% |

| |NHL (n=11) |18% |

|positive – SUV > 3 (n=8) |HD (n=4) |25% |

| |NHL (n=4) |100% |

N Maisey, et al. Eur J Cancer. 36:200-206, 2000. – Royal Marsden

prospective study

24 pt with residual mass after treatment (33 HD, 25 NHL) underwent 18FDG-PET between 1990-96

median f/u = 29 mo

|PET scan result | |relapse rate |relapse pattern |

|negative (n=15) |HD (n=9) |44% |75% at site of residual mass |

| | | |25% at other sites |

| |NHL (n=6) |33%% | |

|positive (n=9) |HD (n=3) |0% |5 of 6 at sites of residual mass |

| | | |1 of 6 at other sites |

| |NHL (n=6) |67% | |

K Spaepen, et al. Br J Haematol. 115:272-278, 2001. – Belgium

60 pt with HD treated with chemo + RT & underwent 18FDG-PET after chemo and again after RT

median f/u = 955 days

PET post-chemo & pre-RT – 49 negative, 11 positive

| | |2-yr PFS rate |

|PET post-chemo + RT |negative (n=55) |91% |

| |positive (n=5) |0% |

Gallium-67 scan

- 10 mCi Ga67 given IV and binds to transferrin

- 85% sensitivity for NSHD

- especially important for NSHD

- especially useful in detection of residual disease after treatment (NSHD often leaves scar) & recurrent disease

- normal uptake occurs in the spleen, liver, and bowel ( therefore, not as good for infradiaphragmatic dz

- useful to distinguish residual mass vs necrosis/fibrosis

King, et al. J Clin Onc. 12:306-311, 1994. –

Bipedal Lymphangiogram (LAG)

- indications: CS I-II subdiaphragmatic dz

equivocal abdominal CT

CS I-II supradiaphragmatic dz, no staging lap, intend RT only

- can not evaluate obturator, hypogastric, splenic, or mesenteric nodes

- lymphatic vessels between 1st and 2nd toes on each foot are cannulated with 27G needle

- filling phase films taken 1 hr after dye injection

- nodal phase films taken 24 hr after dye injection

- 85% sensitivity for pelvic and paraaortic nodes

- 95% specificity

- contraindications 2(/2 pulmonary microemboli = poor pulmonary function, ASD, VSD

( special studies:

cytologic examination of effusions, if present

+/- bone marrow bx

- indications = stage III-IV

B symptoms

(WBC, (RBC, (plt

consider for:

bulky dz

- needle aspirate and biopsy via posterior iliac crest

- not performed if clinical stage IA or IIA supradiaphragmatic non-bulky disease

+/- percutaneous liver biopsy

+/- staging laparotomy

- thorough exploration of abdominal cavity + sample LNs from splenic, porta hepatis, celiac, & PA regions

+ splenectomy + wedge bx of right lobe of liver + needle biopsy of both lobes of liver + bilateral BM

biopsy +/- oophoropexy

- indicated only if it alters stage in a way that alters therapy (ie. if considering RT alone for stage I-IIA)

- 30% of clinical stage I-II are up-staged (#1 location = spleen)

- 25% of clinical stage III are down-staged

- appropriate in patients with > 10% risk of subdiaphragmatic disease

- low yield (6-9%) -- female with clinical stage IA supradiaphragmatic disease

clinical stage IA supradiaphragmatic disease located in peripheral site (ex. high neck)

clinical stage IA LPHD, nodular subtype

- high yield (25-35%) -- clinical stage IIA

clinical stage IB & IIB

- immunization prior to splenectomy (Pneumovax for pneumococcal pneumonia, …)

( fertility issues:

if pelvic RT is contemplated in men, consider sperm banking

if pelvic RT is contemplated in women, perform oophoropexy (move ovaries to midline low pelvis behind uterus & clipped)

( tissue diagnosis:

FNA of enlarged lymph node is inadequate

excisional / incisional biopsy of enlarged lymph node allows examination of architecture

steroid administration can obscure diagnosis

( P Mauch, et al. J Clin Onc. 8:257-265, 1990. - Joint Center

retrospective review

552 pt with clinical stage I-II Hodgkin's disease underwent staging lap from

|group |# pt |upstaged |

|female |256 |18% |

|male |296 |29% |

|no B symptoms |444 |21% |

|B symptoms |108 |34% |

|1 site |171 |17% |

|> 2 sites |381 |27% |

|IA, female |65 |6% |

|IA, male |90 |18% |

|IA, 1 site (peripheral) |18 |6% |

( M Leiberhaut, et al. J Clin Onc. 7:81-91, 1989. - Stanford University

retrospective review

915 pt with supradiaphragmatic clinical stage I-II Hodgkin's disease undergoing staging lap from 1968-86

|clinical stage | |# pt |upstaged |extensive splenic involvement |

|I |no B symptoms |126 |21% |6% |

| |B symptoms |11 |9% |9% |

| |LPHD |19 |10% |0% |

| |NSHD |67 |16% |4% |

| |MCHD |39 |31% |13% |

| |female |33 |6% |0% |

| |male |104 |24% |9% |

|II |no B symptoms |615 |31% |13% |

| |B symptoms |163 |28% |16% |

| |LPHD |18 |22% |0% |

| |NSHD |655 |27% |11% |

| |MCHD |89 |52% |34% |

| |female |363 |22% |9% |

| |male |415 |36% |17% |

|All |1 site | |20% | |

| |2 sites | |29% | |

| |3 sites | |26% | |

| |> 4 sites | |33% | |

Natural History

( Nodular Sclerosis Hodgkin's Disease (65%)

- adolescents and young adults typically age 20-40 yr

- 1 male : 1 female

- usually involves lower cervical nodes &/or mediastinum

- frequent thymic involvement

- 60% are stage I-II

- 30% are stage III

- 30% have B-symptoms

- less favorable prognosis than LPHD

( Mixed Cellularity Hodgkin's Disease (20%)

- seen at any age & lacks the early adult peak of NSHD (usually > 40 yr)

- male > female

- less commonly involves the mediastinum

- more commonly presents with abdominal lymph node and splenic involvement

- 60% are stage III-IV

- 30% have B symptoms

- less favorable prognosis than NSHD

( Lymphocyte Predominance Hodgkin's Disease (10%)

- typically age < 16 or > 40 yr

- 3 male : 1 female

- usually involves peripheral LNs and spares the mediastinum

- 85% are stage I-II

- 5% have B-symptoms

- 10-yr overall survival = 90%

- Nodular Subtype:

- long natural history with late relapses are more common than with other types of Hodgkin's disease

- higher risk of developing NHL than with other types of Hodgkin's disease

- many consider it a form of low grade B-cell lymphoma

- 2-6% transform into large cell lymphoma (usually B-cell)

( Lymphocyte Depletion Hodgkin's Disease (5%)

- commonly seen in elderly people, HIV+ patients, & non-industrialized countries

- commonly presents with abdominal adenopathy, with spleen, liver, and bone marrow involvement

& without peripheral lymphadenopathy (ie. advanced stage at diagnosis)

- 85% are stage III-IV

- 60% have B-symptoms

- worst prognosis

( risk of occult subdiaphragmatic disease on staging laparotomy:

|clinical stage |upstaging rate |

|I, LP |10% |

|I, NS |15% |

|I, MC |30% |

|IA, female |6% |

|IA, male |18% |

|IB |25% |

|IIA or IIB |30% |

Essentially all IIA, IB, MC- 30% risk of upstaging

( relapse pattern:

| |median time to relapse |

|lymphocyte predominant |5 yr |

|stage I-IIA |2.5 yr |

|bulky dz |1.5 yr |

80% of relapses occur within 5yr

|initial treatment |relapse pattern |

|RT |outside RT field |

|Chemo |original site of disease |

• Nodal Recurrence is 50-60% after CT alone with bulky disease

( spread pattern:

- spreads to contiguous lymph node groups (SC nodes & upper PA nodes-celiac axis-spleen are contiguous via the thoracic duct)

- visceral involvement 2(/2 extension from adjacent lymph node regions

- direct correlation between extent of disease in the spleen and the likelihood of hematogenous dissemination

- nearly all pt with hepatic or bone marrow involvement have extensive splenic involvement

Prognostic Factors

( age > 40 yr do worse

- Worse OS rate, but not higher RR compared to younger patients

- Only older age has been consistently found to be a significant adverse factor for survival with combined therapy

( stage

( B-symptoms: pt with both wt loss and fever have a particularly poor prognosis

MJ Crunkovich, RT Hoppe, et al. J Clin Onc. 4:472, 1986. & 5:1041, 1987. -

( bulk of disease: pt with > 10 cm bulk or large mediastinal adenopathy (LMA) do worse

Bradley, et al. J Clin Onc. 2493-2498, 1999.

- Approx 50% RR with bulky mediastinal disease treated with RT alone

( histologic type: (best) LPHD ( NSHD ( MCHD ( LDHD (worst)

stage-for-stage they all do about the same

( ESR > 40 do worse (ESR prognostically for HD & LDH for NHL)

( E-lesions do worse

Outcomes

( Stanford Experience with 2,116 pt treated between '68-'96:

|histology |survival |relapse-free survival |

| |5-yr |10-yr |15-yr |5-yr |10-yr |15-yr |

|LPHD |95% |84% |76% |94% |87% |84% |

|NSHD |89% |82% |75% |75% |72% |71% |

|MCHD |83% |72% |60% |75% |72% |70% |

|LDHD |67% |44% |33% |45% |38% |19% |

( Stanford Experience with 1,678 pt treated between '74-'95:

|stage |survival |freedom from relapse |

| |5-yr |10-yr |20-yr |5-yr |10-yr |20-yr |

|I-II (n=978) |93% |88% |79% |85% |81% |80% |

|IIIA (n=330) |92% |83% |69% |77% |75% |72% |

|IIIB (n=168) |81% |72% |55% |75% |73% |71% |

|IV (n=202) |78% |67% |47% |59% |57% |54% |

( Stanford Experience between 1980-94:

|stage |# pt |5-yr OS |10-yr OS |5-yr DFS |10-yr DFS |

|I-II, RT alone |367 |95% |90% |83% |78% |

|I-II, Chemo + RT |231 |95% |92% |89% |89% |

|IIIA |188 |92% |86% |83% |79% |

|IIIB-IV |215 |80% |71% |69% |69% |

| |# pt |5-yr OS |10-yr OS |5-yr DFS |10-yr DFS |

|laparotomy staging (PS I-IIA) |233 |96% |92% |85% |80% |

|clinical staging (CS I-IIA) |92 |91% |91% |86% |86% |

( outcome by stage: ??

|Stage |10-yr OS rate |10-yr DFS rate |

|IA |95% |90% |

|IB |90% |85% |

|IIA |90% |85% |

|IIB |85% |80% |

|IIIA |85% |80% |

|IIIB |75% |70% |

|IV |65% |60% |

cure rate: stage I-II 80%

stage III-IV 60%

( after 12 yr, death from other causes dominates the causes of death

Early Stage Patients

# Pt Stage F/u Therapy 5 yr OS 5 yr DFS

Full dose IR alone (IR or EF)

Stanford (Donaldson JCO 8: 128, 1990) 48 PS I/II 10 yrs EF RT 86% 82%

Intergroup (Gehan 65: 1429, 1990) 39 PS I/II 5 yrs IF RT 95% 41%

58 PS I/II 5 yrs EF RT 96% 67%

Full Dose RT + CT

Intergroup (Gehan 65: 1429, 1990) 97 PS I/II 5 yrs IF RT 90% 95%

MOPP x 6

Low Dose RT + CT

Stanford (Hunger JCO 12: 2160, 1994) 27 PS I/II 10 yrs MOPP x 6 100% 96%

(Donaldson Pediatr Clin No Am 38: 457, 1991) 44 CS/PS I-III MOPPx3/ABVDx3 100% 100%

St Judes’ (Hudson JCO 11: 100, 1993) 28 CS I-IIB 5 yrs IF RT + COP(P)x4-5 96% 96%

Or IF RT + ABVDx3-4

CT Alone

Uganda (Olweny Cancer 42: 787, 1978) 38 CS I/II 5 yrs MOPP x 6 100% 100%

Advanced Stage Patients

# Pt Stage F/u Therapy 5 yr OS 5 yr DFS

Stanford (Hunger JCO 12: 2160, 1994) 28 III-IV 7.5 yrs IF 15-25 Gy 78% 84%

MOPP x 6

(Donaldson Pediatr Clin No Am) 13 IV 10 yrs IF 15-25 Gy 85% 69%

MOPPx3/ABVDx3

French (SFOP) 69 I/IIB, III-IV 2.5 yrs IF + PA 20 Gy 95% 93%

(Dionet IJROBP 15: 341, 1988) MOPPx3/ABVDx3

CCG 521 111 III-IV 3 yrs no RT 90% 77%

(Hutchinson Med Pediatr Onc 21: 61, 1993) MOPPx 6/ABVDx6

III-IV 3 yrs IF 21 Gy

ABVD x 6 90% 84%

POG (Weiner JCO 9: 1591, 1991) 62 IIB-IV 3-5 yrs TNI 21 Gy 91% 77%

MOPPx4/ABVDx4

(Weiner JCO 15: 2769, 1997) 81 IIB, IIIA2 no RT 96% 79%

MOPPx4/ABVDx4

80 IIIB, IV IF 21 Gy 87% 80%

MOPPx4/ABVDx4

SIOP 65 IV 8 yrs IF 20 Gy

(Schellong Baillieres Clin Haem 9: 619,1996) OPPAx2/COPPx4 93% 78%

St. Jude 57 III-IV ?? IF 20 Gy 93% 93%

(Hudson JCO 11: 100, 1993) COP(P)x4-5/ABVDx3-4

Treatment

Chemotherapy

( MOPP:

- first successful drug combination

- Mechlorethamine (Nitrogen Mustard) 6 mg/m2 IV on days 1 and 8

- Vincristine (Oncovin) 2 mg/m2 IV on days 1 and 8

- Procarbazine 100 mg/m2 PO on days 1-14

- Prednisone 40 mg/m2 PO on days 1-14

- q4wk cycle

- acute toxicity = N/V, peripheral neuropathy, constipation, leukopenia, thrombocytopenia

- late toxicity = sterility (80%), AML (5% with latency period of 3-7 yr)

- Less sterility with 3 cycles of MOPP

COPP

- Same as above but substitute cyclophasphamide for mechlorethamine

( ABVD:

- Adriamycin 25 mg/m2 IV on days 1 and 15 ( maximum cumulative dose = 450 mg/m2

- Bleomycin 10 mg/m2 IV on days 1 and 15

- Vinblastine 6 mg/m2 IV on days 1 and 15

- Dacarbazine 375 mg/m2 IV on days 1 and 15

- q4wk cycle

- acute toxicity = N/V, hair loss, myelosuppression (less than with MOPP)

- late toxicity = cardiac, pulmonary

o In comparison to MOPP, ABVD showed higher FFP but no significant difference in OS

• EBVP II

- Epirubicin

- Bleomycin

- Vinblastine

- Prednisone

( MOPP/ABVD:

- MOPP on days 1-14

- ABVD on days 29 and 43

- q8wk cycle

- non-cross-resistant drugs are used to prevent emergence of resistant clones

( MOPP-ABV hybrid:

- MOPP on days 1-7

- Adriamycin 35 mg/m2 IV on day 8

- Bleomycin 10 mg/m2 IV on day 8

- Vinblastine 6 mg/m2 IV on day 8

- Prednisone 40 mg/m2 PO on days 8-14

- q4wk cycle

( PAVe: Procarbazine, Alkeran, Vinblastine

( VBM: Vinblastine, Bleomycin, Methotrexate

( BCVPP: BCNU, Cytoxan, Vinblastine, Procarbazine, Prednisone

( ChlVPP: Chlorambucil, Vinblastine, Procarbazine, Prednisone

( MVPP: Mechlorethamine, Vinblastine, Procarbazine, Prednisone

( EBVP: Epirubicin, Bleomycin, Vinblastine, Prednisone

( Stanford V: Adriamycin, Vinblastine, Mechlorethamine, Vincristine, Bleomycin, Etoposide, Prednisone

aka. ABV/MO Prednisone Etoposide

( BEAM: BCNU, Etoposide, Ara-C, Melphalan (preparation for BMT

• Number of cycles

- Some data suggest that 4 cycles may be as effective as 6 cycles in controlling occult abdominal disease

- But uncertain on the number of cycles needed to control microscopic disease

- Current German study is randomizing pt to 2-4 cycles of ABVD and IF RT

Radiation Therapy

- RT considerations

o Never more than 150 cGy/d when entire heart or lungs are in field

o Dose inhomogeneity can be improved with extended SSD

o Rec 6 mV Mantle and 6-18 mV Para-aortic

- IF considerations

o Treat a region, not an individual LN

o Usually use involved pre-chemotherapy sites and volume with the exception of the transverse diameter of the mediastinal and para-aortic LN for which post-chemo volumes used

o Supraclavicular LN are considered as part of cervical region and if involved alone or with other cervical LN, the whole unilateral neck is treated. If the supraclav is an extension of mediastinal disease and other neck areas are not involved (CT and PET) the upper neck (above larynx) is spared

Unilateral Cervical/Supraclavicular Field:

Indications: Involvement of any cervical level with or without involvement of supraclav

Simulation

Arms akimbo or at sides

Borders

Superior= 1-2 cm above the tip of mastoid process and midpoint through the chin

Lower = 2 cm below the bottom of the clavicle

Lateral = Medial 2/3 of the clavicle

Medial = Supraclav LN not involved, place border at ipsilateral transverse process (unless original LN

on staging CT lies close to vertebral bodies and then the entire vertebral body is included)

Supraclav LN + -- Then Border placed at the contralateral transverse process

For Stage 1 pts the larynx and vertebral bodies above larynx can be blocked

Blocking:

Posterior cervical block is required only if cord dose >40 Gy. (mid neck calcs should be done)

Block Larynx unless LN in field. If treat Larynx, add block at 1980 cGy

[pic]

Bilateral Cervical/Supraclavicular Field:

Simulation

Arms akimbo or at sides

Borders

Superior= 1-2 cm above the tip of mastoid process and midpoint of chin

Lower= 2 cm below the bottom of the clavicle

Lateral= Medial 2/3 of the clavicle

Blocking

Posterior cervical block is required only if cord dose > 40 Gy (mid neck calcs should be done)

Block larynx unless LN In field in which case add block at 1980 cGy

Axillary Region:

Indications: Axilla involvement

Target volume: ipsilateral axillary, infraclavicular and supraclavicular

Simulation

Arms should be up or akimbo

Borders

Superior = C5-C6 interspace

Inferior border = The lower of either

a. Tip of the scapula

b. 2 cm below the lowest axillary LN

Medial = Ipsilateral cervical transverse process. Include vertebral bodies only if the SCL are involved

Lateral = Flash axilla

[pic]

( Mantle Field:

dental exam & fluoride tx before RT

General Reference points: Sternal notch T2-T3, carina T5, Xyphoid T10,

target volume:

- all major lymph node regions above the diaphragm (submandibular, cervical, supraclavicular, infraclavicular, axillary,

mediastinal, & hilar nodes)

- excludes pre-auricular nodes and Waldeyer's ring

- post-chemo volumes) for lateral extent only, use pre-chemo volumes for craniocaudal extent

- approx 8 cm wide

simulation:

- supine with (-cradle immobilization

- may have to treat PA field prone if gantry can't rotate 180( with extended SSD (110-130 cm)

- neck hyperextended; tape chin & forehead – allows tx of submandibular nodes yet moving the oral cavity out of the field

- arms above head (adults) – pulls axillary nodes laterally & allows more lung to be shielded

can’t block humeral heads b/c lower axillary nodes move up toward it

- hands on hips / akimbo (prepubertal kids) – allows blocking of the humeral epiphysis, but treats more lung

- Hands on hips used unless treating axillary LN

- BB on thyroid notch

- BB on dose-calculation points – axilla, SCF, …

- wire around enlarged nodes or on scar if node excised

- Recommend placing wire around the breast in females

Set-up Considerations

- 7 point set up technique is used for positioning

CAX (central axis), Right and left points

- 2 points along horizontal axis spaced 10 cm from CAX to facilitate shoulder alignment

- 1 point at the inferior border

- 1 point at the superior border

AP/PA with 6 MV photons prescribed at MPD (C-spine runs at ~ 110%; higher energy would underdose superficial nodes)

perform an irregular field point calculation for each important nodal group & isocenter:

central axis isocenter at MPD

neck midway from upper border to base of neck at anterior border of SCM muscle

SCF 1-2 cm medial to mid-clavicular line & just superior to the clavicle

axillae apex of axilla at MPD

mid-mediastinum mid-point of sternum at MPD

lower-mediastinum 3 cm above the lower border of the field at MPD

borders:

superior = (AP) BB just above mentum (dip between lip & chin) to split mandible but spare teeth

(PA) lower 1/3 of mastoid process / tragus

inferior = T9/10 interspace (covers diaphragm insertion)

possibly T8/9 to avoid spleen if treating paraaortic field – watch breathing under fluoro and place

border above cephalad excursion of diaphragm

lateral = lateral edge of humeral head / surgical neck of humerus to include axilla

Borders: For LN – disease in neck suggested ASTRO 2002

Superior = C5-C6 interspace. If supraclavicular LN involved, top should be at top of larynx

Inferior = 5 cm below carina OR 2 cm below pre-chemotherapy volume

Lateral = 1.5 cm margin on post-chemotherapy volumes

Hilar = 1.0 cm margin on hila unless involved and then 1.5 cm

Borders for LN + disease in neck

Mantle without the axilla if both necks involved

If only one neck involved, then contralateral upper neck and larynx can be blocked as per neck guidelines.

Neck above larynx should be shielded at 3060 cGy

If Para cardiac LN are involved, the whole heart should be treated to 14.4 Gy and initially involved LN

treated to 3060

blocking:

(1) lung blocks

superior = (AP) 2 cm below clavicle to include IC nodes

(PA) may be closer to clavicle b/c nodes & clavicle are anterior (?along posterior 4th rib)

lateral = 1 cm margin on chest wall to insure adequate coverage of axillary nodes

extend straight laterally @ 6th rib junction with CW below axilla (~ tip of scapula)

medial = 1 cm margin on superior mediastinum

1.5 cm margin on hilum (ie. bifurcation of mainstem bronchus)

if no bulky mediastinal dz or pericardial LAD, block at transverse processes (8 cm wide)

below hilum to treat mediastinum but maximally shield heart ( add subcarinal block

at 30 Gy (horizontal line 5 cm below carina)

if bulky mediastinal dz with subcarinal extension, pericardial LAD, or pericardial effusion,

initial medial border of left lung block is 1 cm along the cardiac border to treat entire

cardiac silhouette ( add apex block (at transverse processes to include mediastinum only – 8 cm

wide) at 15 Gy ( may add subcarinal block at 25-30 Gy if not blocking disease

if bulky mediastinal dz, consider using shrinking-field technique after each 15 Gy

(re-sim after 10-14 d break ( widen lung block as tumor shrinks)

(2) subcarinal heart block

add at 30 Gy (consider adding at 25 Gy if prior adriamycin)

horizontal line 5 cm below the carina

omit if subcarinal LAD

(3) for pulmonary involvement,

if RT alone, use 37% partial transmission lung blocks to deliver ~ 15 Gy to whole lung

if Chemo + IF RT, treat only residual pulmonary disease ??

(4) trapezoid larynx block in AP field

add at 20 Gy unless involved LN near larynx

~ 2 cm long (thyroid notch to cricoid cartilage) x 2 cm wide (between pedicles)

omit if anterior cervical LAD

clinically ( set-up of block on machine to ensure not blocking cervical nodes

(5) humeral heads in AP & PA fields if akimbo position (esp. children)

along inferior edge of humerus, around humeral head, 1 cm medial & above AC-joint, then lateral

(6) occipital block in PA field

blocks divergence thru oral cavity

borders: superior = field edge

inferior = block lips & commissure, stay just above lower teeth so not to block level I nodes

lateral = 2 cm mandible margin so not to block level II nodes

(7) C-spine cord block in PA field

add at beginning or at 30 Gy

2 cm wide with inferior extent @ bottom of C7

prevents overdosing of the C-spine & Lhermitte's syndrome

important if needs BMT in future b/c TBI is ~ 10 Gy

remember, C-spine gets ~ 110% of daily dose (ex. 36 Gy in 1.8 Gy fx ( C-cord sees 40 Gy in 2 Gy fx)

(8) 2 x 2 cm long midline cheater block at inferior border of PA field

avoids spinal cord overlap between mantle and paraaortic fields

OK b/c lymphatics are sparse here

prescription:

RT alone: field1 = mantle + entire cardiac silhouette

dose1 = 1500 cGy in 150 cGy x 10 fx

field2 = add cardiac apex block

dose2 = 1440 cGy in 180 cGy x 8 fx (total = 2940 cGy)

field3 = add subcarinal block

dose3 = 720 cGy in 180 cGy x 4 fx (total = 3660 cGy)

field4 = bulky dz

dose4 = 360-900 cGy in 180 cGy x 2-5 fx (total = 4020-4500 cGy)

field1 = mantle

dose1 = 3060 cGy in 180 cGy x 17 fx

field2 = add subcarinal block

dose2 = 540 cGy in 180 cGy x 3 fx (total = 3600 cGy)

field3 = bulky dz

dose3 = 360-900 cGy in 180 cGy x 2-5 fx (total = 3960-4500 cGy)

Chemo + RT: field1 = involved nodal regions

dose1 = (non-bulky dz) 3060 (CR) – 3600 (PR)

(bulky dz) 3600 (CR or PR)

( Mini-Mantle Field:

sim as above

includes bilateral necks + bilateral axilla + upper mediastinum to level of the carina

[pic]

( High-Mantle Field:

indications:

unilateral cervical nodal involvement above hyoid bone or preauricular involvement

additional target volume:

ipsilateral preauricular & postauricular nodes

borders:

superior border is extended to top of pinna of ear

blocking:

oral cavity and contralateral parotid gland

put wire on mentum

medial – ipsilateral commissure of lips

lateral – mid-mandible

( Preauricular Field:

indications:

clinical involvement of the preauricular nodes

prophylactically when cervical nodes above thyroid notch are clinically involved

target volume:

preauricular nodes

unilateral field with 8-9 MeV e- (spares opposite parotid)

borders:

superior = bisects sphenoid sinus / top of zygomatic arch / 2 cm above tragus / just below superior edge of helix

inferior = matched on skin to the mantle field

posterior = just anterior to the external auditory canal

anterior = posterior to last molar / anterior edge of masseter muscle

dose:

RT alone = (prophylactic) 3000 cGy

(gross dz) 3600 cGy

Chemo + RT = (gross dz) 3060 cGy

( Waldeyer Field:

Waldeyer's ring = palatine tonsil, base of tongue (lingual tonsil), nasopharynx (adenoids)

indications:

involvement of tonsils, nasopharynx, or bilateral preauricular nodes

bulky upper cervical nodes, not adequately covered by a mantle field

target volume:

submandibular, preauricular, occipital, and upper cervical nodes

bilateral opposed fields

6 MV photons

wires on lateral bony canthi during sim

borders:

superior = bisects sphenoid sinus / inferior pituitary fossa

inferior = matched to mantle field below gross dz (thyroid notch if possible; otherwise low neck) – ? HBB both fields

posterior = cover spinous processes

anterior = flash mandible

blocking:

bisect mandible to block portion of oral cavity

posterior ¼ of orbits, posterior 1/3 of nasal cavity

( Extended Mantle Field:

includes paraaortics and spleen, thus avoiding matching problems

requires extended SSDs and limited to short pt

not used much anymore b/c of increased morbidity

( Epitrochlear Field::

nodes located in medial half of arm if rotated outward

( Subdiaphragmatic Fields:

2 wk break between mantle and paraaortic field b/c of fatigue and to allow bone marrow to recover

If you know you will be treating spleen/PNI at time of mantle, need to consider where to match and watch

breathing under flouro

matching techniques:

(1) at MPD*

set up mantle field

calculate gap (typically ~ 1-2 cm)

G1 = ½L1 ( field size at MPD* _G1 = ½L1 ( field size on skin with ruler

MPD SAD d SSD

potential cold spot in front of vertebral bodies where paraaortic nodes are located

typically not a problem b/c lymphatics are sparse around level of the diaphragm where match is

could use asymmetric jaws on mantle field so divergence is the same as the paraaortic field

2) Skin Gap

S1 = L1/2 * d/SSD1 where L is field width and e is depth at which 2 field edges cross

Total gap = S1 + S2

(d)S = S1 – S2

Give 4-6 week treatment break between mantle and paraaortic fields

Use asymmetric jaws to maintain same angle of divergence between inf mantle and sup PA

Alternatively, a 2 x 2 cm cord block can be placed at border of PA field

(2) at anterior edge of vertebral body ???

set up PA mantle field and mark inferior border on skin with wire

match PA paraaortic field exactly

Paraaortic / Splenic Pedicle Field

sim with CT or IVP for kidney position

target volume:

paraaortic, celiac, splenic, hepatic nodes

spleen or splenic pedicle

AP/PA with 18 MV photons

borders:

superior = matched to the mantle field (T8/9) with calculated gap

inferior = L4/5 interspace (aorta bifurcates at L3-4)

left = outer rib cage

right = transverse processes

splenic pedicle + 2.5-3 cm margin on clips if s/p splenectomy

spleen + 1.5 cm margin (post-chemo vol), if present (only 1 cm margin in region of kidney)

2 x 2 cm cheater block in superior edge of PA field (OK b/c lymphatics are sparse here)

Para-aortic Field

Superior = Top of T11 and at least 2 cm on pre-chemo volumes

Lower = Bottom of L4 and at least 2 cm of pre-chemo volumes

Spade Field:

sim with CT or IVP for kidney position

target volume:

paraaortic, celiac, splenic, hepatic nodes

spleen or splenic pedicle

common iliac nodes

borders:

superior = matched to the mantle field (T8/9) with calculated gap

inferior = below aortic bifurcation at S1/2 (~ L5/S1 & no lower than top of SI joints if female with no oophoropexy)

lateral = splenic pedicle + 2.5-3 cm margin on clips if s/p splenectomy

entire spleen + 2 cm margin, if present (only 1 cm margin in region of kidney)

transverse processes down to L4

oblique line from lateral tip of transverse process of L4 to point 1.5-2 cm beyond pelvic inlet

Inguinal/Femoral/External Iliac Region:

Groups are treated together if any are involved

Borders

Superior – Middle of SI joint

Inferior – 5 cm below lesser trochanter

Lateral – greater trochanter and 2 cm lateral to initially involved LN

Medial- medial border of the obturator foramen with 2 cm medial to involved LN

Note if common iliac LN are involved, the field should be extended to L4-L5 interspace

Inverted Y Field:

target volume:

paraaortic, celiac, splenic, hepatic nodes

spleen or splenic pedicle

pelvic nodes

simulation:

supine

fluoroscopy – watch spleen motion with breathing & include entire hemidiaphragm with upper border

CT planning:

depth of inguinal nodes for calculation point

determines position of spleen & kidneys

AP/PA with 18 MV photons

borders:

superior = matched to the mantle field (T8/9) with calculated gap

if no prior mantle field, watch spleen move under fluoro and include entire hemidiaphragm

inferior = bottom of obturator foramen (female) or ischial tuberosities (male)

left = outer rib cage

right = transverse processes

splenic pedicle + 2.5-3 cm margin on clips if s/p splenectomy

entire spleen + 2 cm margin, if present (only 1 cm margin in region of kidney)

diverge at L4/5, 1.5-2 cm lateral to pelvic inlet, & spare femoral head

blocking for pelvic field:

iliac wing blocks to spare bone marrow

midline block for bladder & rectum – superior = top of femoral heads vs symphysis pubis ???

lateral = medial edge of obturator foramina

if s/p oophoropexy, use 10 HVL thick block & ensure ovaries under block by at least 2 cm

testicular shield – ~ 1 cm thick lead shield

not designed to block 6 MV photons (~ 5 cm lead), just scattered lower energy photons

used if can position it under the MLB; otherwise, leave it out

dose: RT alone: subclinical dz = 3060 cGy

gross dz = 3600 cGy

bulky dz = 3960 cGy

post-chemo RT: (non-bulky dz) 3060 cGy (CR) – 3600 cGy (PR)

(bulky dz) 3600 cGy (CR or PR)

Inverted Y Including Inguinal Nodes

see above

6 MV photons to adequately dose groin nodes – if pt separation > 25 cm may need ( energy + 1 cm bolus

borders:

superior = watch spleen move under fluoro and include entire hemidiaphragm

inferior = 8 cm below inguinal ligament or straight line 2.5 cm below ischial tuberosity

lateral = right transverse processes

splenic pedicle + 2.5-3 cm margin on clips if s/p splenectomy

entire spleen + 2 cm margin (1 cm margin near kidney), if present

diverge at L4/5, 2 cm lateral to pelvic inlet

cover medial 2/3 of inguinal ligament (ant sup iliac spine ( pubis) or lateral edge of femoral head

Whole Lung Field:

May give chemo with pulmonary parenchymal involvement and then RT to post-chemo volumes which may

mean no lung RT

Typically treat Mantle field with infereior border at diaphragmatic crura (T12)

Lungs are treated through a partial (50%) transmission blocks

Dose is 10 – 15 Gy in 0.9 Gy fractions

STAGE IA, IB, & IIA SUPRADIAPHRAGMATIC HODGKIN'S DISEASE

Age > 16 yr

( initial therapy is determined by prognostic factors such as number of nodal regions involved, size of nodal

involvement, pt age, & presence of B-symptoms

Clinical Stage IA & IIA with “favorable” features defined by the EORTC studies (~ 60% of stage I-II pt)

1-3 nodal sites involved

no bulky disease (LMA (> 1/3 thoracic diameter at T5/6) or > 5 cm for peripheral nodes)

no B-symptoms (EORTC uses no B-sx + ESR < 50 or B-sx + ESR < 30)

age < 50 yr

ESR < 50 (PMH uses ESR < 40)

LP or NS histology (even stage I MC has a 30% risk of subdiaphragmatic dz & 15% risk of extensive splenic involvement – Stanford)

( Mantle RT alone without prior staging lap

not off protocol

may consider for stage IA LP HD in peripheral nodal site (ie. above thyroid notch or epitrochlear), female, age < 40, ESR < 50

EORTC H7VF group may be adequately treated with mantle alone (long-term results not available)

( Staging Lap & if (-), then Mantle RT alone

field1 = mantle

dose1 = 3060 cGy

field2 = add subcarinal block

dose2 = 540 cGy

total dose = 3600 cGy

( Extended-Field RT without Staging Lap

consider getting a lag 1st to better assess pelvic and PA nodes (esp. with CS II or MC/LD histology)

field1 = mantle

dose1 = 3060 cGy in 180 cGy x17 fx

field2 = add subcarinal block

dose2 = 540 cGy in 180 cGy x 3 fx (total = 3600 cGy)

2 wk break to allow return of energy and recovery of blood counts

field3 = paraaortics + spleen

dose3 = 3060 cGy in 180 cGy x17 fx

pelvic relapse rate = 5% for LP/NS vs 11% for MC

( ABVD x 4

Involved Field RT (30-36 Gy per NCCN guidelines)

field1 = involved nodal sites (excluding uninvolved axilla significantly reduces volume of breast irradiated)

minimum of 2 cm margin on pre-chemo disease (except bulky mediastinum dz pushing into lung)

typically more than just Ann Arbor site ( mini-mantle; bilateral necks + upper mediastinum, …

Stanford – always include SC & hila if treating mediastinum; may ( upper border to thyroid notch

dose1 = (CR) 3060 cGy (Dr Dawson at U of M – 30 Gy + CD to pre-chemo dz to 36 Gy)

(PR) 3600 cGy

( Note: optimal RT dose with chemo is unknown

no consensus on definition of IF RT

unclear how much chemo is needed with RT

chemo + RT ( DFS without ( OS compared to STLI

no randomized trials for adults comparing chemo alone vs chemo + RT

ongoing EORTC H9F – closed chemo alone arm b/c relapse

proposed CALGB/SWOG trial

PEDS trials closed early b/c of ( relapse rate in chemo alone arm

NCCN recommendations for favorable CS IA-IIA = ABVD x 4 + IF RT (30-36 Gy)

Stage I Nodular LPHD in Upper Neck

( Mini-Mantle RT Alone

no chemo

rarely involves the mediastinum

36 – 40 Gy alone

- Note ASTRO 2003 rec were to AVOID mediastinal RT and CHEMO

Clinical Stage I-II with “unfavorable” features defined by the EORTC studies that benefit from addition of chemo (~ 40% of stage I-II pt)

> 4 nodal sites involved

bulky disease (LMA (> 1/3 thoracic diameter at T5/6) or > 5 cm for peripheral nodes (some say > 10 cm))

B-symptoms (esp. fever and wt loss) (EORTC uses no B-sx + ESR > 50 or B-sx + ESR > 30)

age > 50 yr

ESR > 50 (PMH uses ESR > 40)

MC/LD histology

( ABVD x 4-6 cycles (2 cycles beyond CR)

typically 4 cycles without bulky dz & 6 cycles with bulky dz

giving chemo first allows assessment of chemo response

maximization of the amount of drug needed

smaller radiation fields

re-staging CT and PET vs. Gallium scans after every 2 cycles

if (+)PET after 4 cycles of ABVD:

if LMA is shrinking & only slightly (+), then give 2 more cycles of chemo & re-stage

if not shrinking & strongly (+), then biopsy & give high dose chemo with stem cell rescue

Involved Field RT (30-36 Gy per NCCN guidelines)

field1 = involved nodal sites (excluding uninvolved axilla significantly reduces volume of breast irradiated)

minimum of 2 cm margin on pre-chemo disease (except bulky mediastinum dz pushing into lung)

typically more than just Ann Arbor site ( mini-mantle; bilateral necks + upper mediastinum, …

Stanford – always include SC & hila if treating mediastinum; may ( upper border to thyroid notch

dose1 = (CR) 3060 cGy (Dr Dawson at U of M – 30 Gy + CD to pre-chemo dz to 36 Gy)

(PR) 3600 cGy

field2 = bulky dz + 2 cm

total dose = (CR or PR) 3600 (ASTRO 2001 refresher course recommends 36-40 Gy for bulky dz)

( Note: EF RT = IF RT if give 4-6 cycles of chemo

ABVD is superior to MOPP

hybrid regimens are more toxic & don’t add to survival

4 cycles of chemo is likely sufficient

NCCN recommendations for unfavorable CS I-II = ABVD x 4-6 (CR+2) + IF RT (30-36 Gy)

PMH Recommendations:

CS IA or IIA with LP/NS histology, no bulky dz, age < 50 yr, ESR < 40

Extended-field RT alone to mantle (35 Gy) + PA (25 Gy)

CS IA or IIA with MC histology, age > 50 yr, ESR > 40

ABVD x 2 cycles ( RT to mantle (35 Gy) + PA (25 Gy)

CS IB or IIB &/or bulky mediastinal mass

ABVD to CR + 2 cycles ( RT to upper mantle (35 Gy)

1991 Patterns of Care Recommendations:

RT dose without chemo: uninvolved sites 30-40 Gy

involved sites 36-44 Gy

RT dose with chemo: no consensus on dose, but did recommend a minimum of 25 Gy

S/P Chemo Involved-Field Design (Ann Arbor nodal region):

neck

ipsilateral neck + SC/IC

many recommend bilateral necks + SC/IC + upper mediastinum to 30 Gy with CD to 36 Gy

may need to cross midline to ensure 2 cm on original disease extent

AP/PA

6 MV

superior = (AP) BB just above mentum (dip between lip & chin) to split mandible but spare teeth

(PA) lower 1/3 of mastoid process / tragus

+/- pre-auricular field if disease is above the thyroid notch

inferior = bottom of clavicular head / ensure 2 cm on original disease extent

lateral = medial aspect of acromion to encompass SC and low neck nodes / flash lateral neck skin ??

medial = ipsilateral vertebral pedicles (provided that this ensures 2 cm on original disease extent)

mediastinal disease

T1-T7 with 2 cm margin superiorly & inferiorly

superior = thyroid notch

inferior = 2 cm below disease (spares heart) vs. entire mediastinum with subcarinal block at 30 Gy

lateral = medial 2/3 of clavicle, excluding the axilla

SC + mediastinum

superior = thyroid notch, sparing upper necks and parotids

inferior = 2 cm below disease (spares heart) vs. entire mediastinum with subcarinal block at 30 Gy

lateral = medial 2/3 of clavicle, excluding the axilla

cervical + mediastinum

modify mantle by moving lateral border to cover medial 2/3 of clavicles (be sure to cover SC dz) excluding the axilla

paraaortic disease

AP/PA

18 MV

axilla

ipsilateral axilla + SC/IC

AP/PA

6 MV

J Clin Onc. 16:830, 1998.

J Clin Onc. 8:257, 1990.

J Clin Onc. 7:81, 1989.

Cancer. 65:1155, 1990.

( STLI = mantle + PA

TLI = mantle + inverted-Y

RT Alone Dose-Response Data

( HS Kaplan. Hodgkin’s Disease. Cambridge: Harvard University Press. 1980:689.

|bulk of disease |RT dose (without chemo) required for 95% control rate |

|Subclinical disease |25-30 Gy |

|< 5 cm |30-35 Gy |

|> 5 cm |35-45 Gy |

H Kaplan et al. Cancer Res 26:1221-4; 1966 - Stanford University

landmark article

|dose (rads) |recurrence rate |

|< 1000 rads |78% |

|1000 rads |60% |

|1500 rads |48% |

|2000 rads |35% |

|2500 rads |26% |

|3500 rads |11.5 % |

|4000 rads |4.4% |

comments: included some patients treated with orthovoltage

did not account for tumor bulk

lack of imaging and concern for geographic miss

( E Duehmke, et al. IJROBP. 32:213, 1995. - GHSG (German Hodgkin’s Study Group) HD4-trial

updated in IJROBP. 36:305-310, 1996. & J Clin Onc. 19:2905-2914, 2001.

prospective randomized trial

376 pt with pathologic stage IA-IIB non-bulky HD treated between 1988-93

pt char: only 5% had B-symptoms

all pt underwent staging lap

exclusion criteria: large mediastinal mass, > 5 splenic nodules, extranodal disease, > 3 involved nodal areas,

ESR > 30 (CS B) or 50 (CS A)

stratification: location of disease (supradiaphragmatic vs infradiaphragmatic) & treating institution

randomization: (1) 40 Gy EF-RT @ 1.8-2 Gy fx

(2) 30 Gy EF-RT with boost to 40 Gy to involved nodal regions

RT: EF definition: supradiaphragmatic disease mantle (+ Waldeyer’s ring if high cervical nodes) + PA/splenic pedicle

PA field was excluded if disease was confined to the upper cervical nodes

infradiaphragmatic disease inverted-Y including groin nodes + T-field for mediastinum/SC nodes

T-field was excluded if disease was confined to the inguinofemoral nodes

3-4 wk break between supra- and infradiaphragmatic fields

central review of sim films

median f/u = 86 mo

end-points = freedom-from relapse (FFR), overall survival (OS)

prognostic factors well balanced between treatment groups

protocol violations = majority 2(/2 inadequate margins ( 6 cm disease

prior analysis (with primarily kilovoltage data in 1960s) looked at 1040 sites at risk & suggested a 98% in-field control rate with 44 Gy

re-analysis (including modern megavoltage data) looked at 4117 sites at risk shows similar in-field control rates with ≤ 37.5 Gy

|extent of disease |dose required for 98% in-field control rate |

|subclinical disease |32.4 Gy |

|disease < 6 cm |36.9 Gy |

|disease > 6 cm |37.4 Gy |

K Schewe et al. IJROBP 15: 25-28; 1988 - MCW

retrospective

evaluation of dose-response data between 30-45 Gy from 1970-1982

112 pts with stage I/II disease

58% were pathologically staged

RT: 1970-72 300 cGy on M/W/F alternating AP and PA fields

82. 150-180 cGy, 5 days/wk

split-course = mantle 18 Gy ( PA/spleen 18 Gy ( mantle boost ( PA/spleen boost ( 2-4 wk break ( pelvis

continuous = mantle ( 2-4 wk bread ( inverted-Y field encompassing PA/spleen/pelvis

median f/u 89 months (range 29-183 months)

|dose (Gy) |in-field recurrence (per # nodal groups treated) |

|≤ 30 Gy |10.7% (3/28) |

|30.1-36 Gy |1.7 % (6/344) |

|36.1-39 |2.6% (12/456) |

|> 39 |1.6% (4/252) |

outcome vs. nodal size for doses > 30 Gy:

| |in-field & marginal recurrence (per # nodal groups treated) |

|nodal size | |

|subclinical |1.8% (12/685) |

|0.5-3 cm |4.3% (10/233) |

|> 3 cm |5.2% (7/134) |

** trend toward higher recurrence rates with increasing nodal size but did not reach significance

conclusions: no dose-response relationship for Hodgkin’s disease above 30 Gy

use of doses > 40 Gy for larger nodal volumes does not appear to improve local control

RT Hoppe, et al. Cancer. 74:3198-3203, 1994. - Patterns of Care Study

P Mauch, et al. J Clin Onc. 13:957-952, 1995. - Joint Center

MJ Crnkovich, et al. J Clin Oncol. 5:1041-1049, 1987. - Stanford and Joint Center

RT s/p Chemo Dose Response Data

( M Loeffler, et al. J Clin Onc. 15:2275-2287, 1997. – GHSG (German Hodgkin’s Study Group) HD1 & HD5

prospective randomized trial

260 pt with CS/PS I-IIIA HD with ‘high-risk’ features treated on 2 trials between 1984-92

pt char: 5% stage I, 60% stage II, 36% stage III

eligibility criteria: > 1 of the following (bulky mediastinal dz, massive spleen involvement, extranodal involvement), age 15-60

bulky dz = mediastinal mass > 1/3 thoracic diameter

> 7.5 cm diameter

central path review

HD1 (1984-88):

147 pt

all pt got 4 cycles of chemo: COPP ( ABVD ( COPP ( ABVD

randomization: (1) 40 Gy EF RT

(2) 20 Gy EF RT with 40 Gy to bulky dz

EF RT: upper cervical only Waldeyer’s ring + Mantle

supradiaphragmatic Mantle + Paraaortic + Spleen

supradiaphragmatic + paraaortic Mantle + Inverted-Y + Spleen

infradiaphragmatic

median f/u = 6.5 yr

HD5 (1988-92):

111 pt in arm 1

randomization: (1) COPP ( ABVD ( COPP ( ABVD

(2) IMEP (rapidly alternating COPP/ABV/Ifosfamide, Methotrexate, Etoposide, and Prednisone)

all pt got 30 Gy EF RT with 40 Gy to bulky dz

median f/u = 3 yr

| |RT dose to clinically(-) or non-bulky dz sites | |

| |20 Gy (n=71) |30 Gy (n=111) |40 Gy (n=76) |p-value |

|CR rate |92% |94% |92% |NS |

|4-yr freedom from treatment failure rate |79% |86% |80% |NS |

|4-yr survival rate |94% |93% |88% |NS |

more acute and late radiation complications in the 40 Gy arm

22 of 26 (85%) relapsing pt did so in initial bulky sites, extranodal sites, or outside the RT field

conclusions = (1) following 4 cycles of chemo, LC in clinically (-) sites & non-bulky dz was similar for 20 Gy, 30 Gy, or 40 Gy

(2) 10% failure rate at initial bulky sites after 40 Gy

criticisms = not too useful to know subclinical dz dose b/c only need to treat involved-field

GHSG HD10 Trial

on-going

randomization: (1) ABVD x 2 + IF RT 30 Gy

(2) ABVD x 2 + IF RT 20 Gy

(3) ABVD x 4 + IF RT 30 Gy

(4) ABVD x 4 + IF RT 20 Gy

GHSG HD11 Trial

on-going

randomization: (1) ABVD x 4 + IF RT 30 Gy

(2) ABVD x 4 + IF RT 20 Gy

Mantle RT alone without a Staging Lap

M Tubiana, et al. Blood. 73:47-56, 1989. – EORTC H1

prospective randomized trial

288 pt with supradiaphragmatic clinical stage I-II HD treated between 1964-71

no staging LAP

randomization: (1) mantle RT (n=152)

(2) mantle RT + vinblastine IV q1wk x 2 yr (n=136)

| |mantle RT |mantle RT + vinblastine |p-value |

|15-yr DFS rate |38% |60% |0.001 |

|15-yr OS rate |58% |65% |NS |

high relapse rate in the unirradiated paraaortic region

conclusions = paraaortic region should either be explored or treated

( EM Noordijk, et al. Ann Oncol. 5:S107-S112, 1994. – EORTC H7VF

605 pt with supradiaphragmatic clinical stage I-II HD treated between 1988-

6 prognostic factors to form treatment groups

very favorable group (H7VF): 35 pt

CS IA, NS or LP histology, no bulky dz, age < 40 yr, female, ESR < 50

all pt treated with mantle RT alone

| |mantle RT |

|3-yr RFS rate |82% |

|3-yr OS rate |100% |

conclusions = very favorable HD (CS IA, NS/LP, no bulky dz, age 70 (4) MC/LD histology

favorable group (H5F): 237 pt (9% B-symptoms)

no unfavorable prognostic factors (CS I or II without mediastinal dz, NS/LP histology, age < 40 yr, ESR < 70)

all pt underwent staging lap-splenectomy (39 pt with (+)lap pt were treated on H5U arm)

198 pt with (-)lap, randomized: (1) mantle RT (n=100)

(2) mantle/PA RT (n=98)

field1 = mantle

dose1 = 40 Gy

field2 = PA from T11-L4

dose2 = 40 Gy

| |mantle RT (n=100) |mantle/PA RT (n=98) |p-value |

|CR rate |99% |99% |NS |

|6-yr FFP rate |73% |71% |NS |

|6-yr OS rate |96% |90% |NS |

mean f/u = 5.3 yr

conclusions = favorable stage IA-IIA pt (I or II without mediastinal dz, NS/LP, age 6 cycles (2 cycles beyond maximal response)

(2) RT: dose = 45 Gy

field = IA high neck or axilla only mini-mantle +/- Waldeyer’s

IA inguinal inverted-Y

non-bulky dz limited to mediastinum mantle

IA or IIA supradiaphragmatic dz mantle + paraaortic-spleen

B-symptoms total nodal irradiation

median f/u = 7.5 yr

| |RT (randomized pt) |MOPP |p-value |

|CR rate |96% |96% |NS |

|10-yr OS rate |81% (76%) |92% |0.05 |

|10-yr DFS rate |74% (60%) |86% |0.01 |

all 13% of MOPP pt relapsed in previously involved sites

subgroup analysis: only subgroups with a significant advantage with MOPP are pt with bulky mediastinal dz or IIIA

conclusions = MOPP is at least as effective as RT for treatment of early-stage HD

GP Biti, et al. J Clin Onc. 10:378-382, 1992. - Italy

prospective randomized study

89 pt with stage I-IIA HD treated between '79-'82

all pt underwent staging laparotomy

randomization: (1) RT (n=45)

(2) Chemo (n=44)

RT: mantle and paraaortic irradiation (3 wk rest period between fields)

36 Gy to uninvolved sites & 40-44 Gy to involved sites @ 2 Gy fx

chemo: MOPP x 6 cycles

definition of bulky disease = > 5 cm node or mediastinal mass:thorax ratio > 1/3

end-points = pattern of relapse -- true relapse = within previously involved areas or radiation volume

lymph node extension = in previously uninvolved areas or adjacent to irradiated volume

dissemination = parenchymal involvement

overall survival

relapse-free survival

variables analyzed for prognostic significance = age, sex, histology, stage, mediastinum, bulky dz, ESR, treatment, response

median f/u = 96 mo

patient characteristics were well balanced

| |MOPP chemotherapy |mantle/periaortic RT |p-value |

|complete response rate |91% (40/44) |100% (45/45) | |

|8-yr RFS rate |71% |64% |NS |

|8-yr OS rate |56% |93% |0.001 |

|disease specific mortality |18% (8/44) |4% (2/45) | |

relapse pattern correlated with treatment group:

| |MOPP chemotherapy |mantle/periaortic RT |p-value |

|relapse rate |27% (12/44) |27% (12/45) |NS |

| true relapses |67% (8/12) |8% (1/12) |< 0.01 |

| nodal extension or dissemination |33% (4/12) |92% (11/12) |< 0.01 |

|complete response to salvage therapy |50% |92% | |

outcome with salvage therapy correlated with treatment group:

| |MOPP chemotherapy |mantle/periaortic RT |p-value |

|6.75-yr survival rate |15% |85% |0.02 |

MVA -- treatment, stage, and histology correlated with survival

conclusions = (1) relapse rate was similar for stage I-IIA HD patients treated with MOPP x 6 or mantle/periaortic RT;

however, patients relapsing after MOPP are more resistant to salvage therapy

(2) 8-yr survival rate was significantly better for the RT group

NCI Canada CTG HD6 Study

on-going trial

CS I-II HD with favorable prognostic factors

eligibility criteria: age < 40 yr, NS/LP histology, 1-3 nodal sites, ESR < 50

randomization: (1) ABVD x 4

(2) STLI

EF RT vs IF RT

• Meta-analysis showed increased FFP for EF vs IF RT, but no OS advantage

( Specht L et al. Journal of Clinical Oncology 16:830-843; 1998 – International Hodgkin’s Disease Collaborative Group

meta-analysis of 1,974 pt in 8 trials evaluating RT vs. more extensive RT (larger fields) (1962-1982)

most trials compared extended-field or STLI vs. involved-field RT

some trials included chemo in both arms (always identical)

|Group |Arm |#pt |10-yr failure rate |10-yr OS rate |

|stage IA |more RT | 348 |24% | |

| |less RT | 300 |36% | |

|stage IB |more RT | 22 |18% | |

| |less RT | 19 |47% | |

|stage IIA |more RT | 449 |34% | |

| |less RT | 460 |44% | |

|stage IIB |more RT | 130 |45% | |

| |less RT | 120 |53% | |

|stage IIIA |more RT | 22 |14% | |

| |less RT | 30 |33% | |

|age < 40 |more RT | 772 |30% | |

| |less RT | 757 |40% | |

|age ( 40 |more RT | 221 |35% | |

| |less RT | 205 |49% | |

|all patients |more RT |1005 |31% |77% |

| |less RT | 969 |43% |77% |

Death Due to Other Causes (Not Hodgkin’s)

|Arm |Solid Tumors |Non-Hodgkin’s Lymphoma |Leukemia |All Deaths from Other Causes |

|more RT |2.8% |0.5% |0% |10% |

|less RT |1.3% |0.2% |0.1% | 6% |

conclusions = EF RT ( relapse rate by ~ 10-15% compared to IF RT alone

EF RT does not ( OS compared to IF RT due to excellent salvage therapy

Chemo + EF RT vs EF RT

• Meta-analysis has shown improved DFS in all patients with chemo/EF RT vs EF RT alone, but b/c salvage, no OS has been noted

- Also shown in early results of German trial and SWOG trial

( Specht L et al. Journal of Clinical Oncology 16:830-843; 1998 – International Hodgkin’s Disease Collaborative Group

meta-analysis of 1,688 pt in 13 trials evaluating chemo + RT vs. RT (1967-1988)

included 476 patients in trials evaluating chemo + RT vs. same RT (unconfounded)

included 1219 patients in trials evaluating chemo + less RT vs. more RT (confounded)

most trials used MOPP or variants of MOPP

|Group |Arm |# pt |10-yr failure rate |10-yr OS rate |10-yr CSS rate |

|stage IA |chemo + RT |191 |11% | | |

| |RT |186 |20% | | |

|stage IB |chemo + RT |25 |4% | | |

| |RT |30 |37% | | |

|stage IIA |chemo + RT |336 |15% | | |

| |RT |326 |28% | | |

|stage IIB |chemo + RT |112 |24% | | |

| |RT |118 |38% | | |

|stage IIIA |chemo + RT |105 |20% | | |

| |RT |122 |42% | | |

|stage IIIB |chemo + RT |24 |46% | | |

| |RT |25 |80% | | |

|age < 40 |chemo + RT |647 |15% | | |

| |RT |650 |31% | | |

|age ( 40 |chemo + RT |179 |19% | | |

| |RT |194 |31% | | |

|all patients |chemo + RT |839 |16% |79% |88% |

| |RT |856 |33% |77% |85% |

Death Due to Other Causes (Not Hodgkin’s):

|Arm |Solid Tumors |Non-Hodgkin’s Lymphoma |Leukemia |All Deaths from Other Causes |

|chemo + RT |3.5% |0.4% |1.1% |13% |

|RT |2.6% |0% |0.5% |11% |

conclusions = chemo + RT ( relapse rate by ~ ½ (30% ( 15%) for all stages of HD compared to RT alone

chemo + RT does not improve OS or CSS compared to RT alone due to excellent salvage therapy

preliminary data from ASTRO 2001 refresher course – GHSG HD7

1994-98

643 pt with CS IA-IIB HD & favorable prognostic factors

randomization: (1) ABVD x 2 + STLI

(2) STLI

| |ABVD x 2 + STLI |STLI |p-value |

|RFS rate |96% |87% |0.05 |

Press, et al. J Clin Onc. 2001. – SWOG 9133 / CALGB 9391

prospective randomized trial

randomization: (1) AV x 3 + STLI

(2) STLI 36-40 Gy

( recurrence rate with chemo + STLI but no difference in OS

Chemo + Mantle RT vs. EF RT

M Tubiana, et al. Blood. 73:47-56, 1989. – EORTC H1

prospective randomized trial

288 pt with supradiaphragmatic clinical stage I-II HD treated between 1964-71

no staging LAP

randomization: (1) mantle RT (n=152)

(2) mantle RT + vinblastine IV q1wk x 2 yr (n=136)

| |mantle RT |mantle RT + vinblastine |p-value |

|15-yr DFS rate |38% |60% |0.001 |

|15-yr OS rate |58% |65% |NS |

high relapse rate in the unirradiated paraaortic region

conclusions = paraaortic region should either be explored or treated

( P Carde, et al. J Clin Onc. 6:239-252, 1988. – EORTC H5U

prospective randomized trial

494 pt with supradiaphragmatic clinical stage I-II HD treated between 1977-82

eligibility criteria: age 15-70 yr, normal LAG

4 unfavorable prognostic factors: (1) CS II with mediastinal dz (2) age > 40 yr (3) ESR > 70 (4) MC/LD histology

mean f/u = 5.3 yr

unfavorable group (H5U): 257 pt (24% B-symptoms) & 30 pt with +lap from H5F group

any of 4 unfavorable prognostic factors

no staging lap

randomization: (1) TNI or STNI (n=132)

(2) MOPP x 3 + mantle RT + MOPP x 3 (“3M protocol”) (n=135)

TNI: field1 = mantle

dose1 = 40 Gy

field2 = PA + spleen + iliac + inguinal regions (optional in young women)

dose2 = 40 Gy

3M: field = mantle

dose = 35 Gy

| | |TNI (n=132) |MOPP + mantle RT + MOPP (n=135) |p-value |

|CR rate |H5U group |95% |98% |NS |

| |(+)lap pt |90% |89% |NS |

|6-yr FFP rate |H5U group |73% |89% |0.01 |

| |(+)lap pt |47% |89% |0.008 |

|6-yr OS rate |H5U group |82% |89% |0.05 |

| |(+)lap pt |95% |88% |NS |

*for H5U group pt < 40 yr old, there was no difference in OS between treatment arms

conclusions = unfavorable stage I-II pt (II with mediastinal dz, MC/LD, age>40, ESR>70) should receive chemo + mantle RT

instead of TNI or STNI

Chemo + IF RT vs EF RT

( EM Noordijk, et al. Ann Oncol. 5:S107-S112, 1994. – EORTC H7F

605 pt with supradiaphragmatic clinical stage I-II HD treated between 1988-

6 prognostic factors to form treatment groups

favorable group (H7F): 354 pt

CS I (other than above)

CS II, < 3 Ann Arbor sites, age < 50 yr, ESR < 50

randomization: (1) mantle/PA/spleen RT

(2) EBVP x 6 + involved-field RT

| |mantle + PA/spleen RT |EBVP x 6 + IF RT |p-value |

|3-yr RFS rate |81% |71% |NS |

|3-yr OS rate |99% |100% |NS |

EBVP: Epirubicin

Bleomycin

Vinblastine

Prednisone

conclusions = favorable HD (all other CS I, CS II with 2-3 involved nodal sites, age 5 cm

STLI: mantle RT + PA/spleen RT

40-44 Gy to involved regions

30-40 Gy to uninvolved regions

> 40 Gy to involved extranodal sites

VBM: q4wk cycles

vinblastine 6 mg/m2 IV on d 1 & 8

bleomycin 10 U/m2 IV on d 1 & 8 ( 2.5 U/m2 for 4 cycles after RT

methotrexate 30 mg/m2 IV on d 1 & 8

IF RT: started 2 wk after VBM

mediastinal mantle field

neck or axilla bilateral neck + axilla + upper mediastinum to 2 cm below head of clavicles

35-36 Gy to involved regions

30-35 Gy to uninvolved regions

median f/u > 4 yr

| |STLI (n=43) |VBM x 2 + IF RT + VBM x 4 (n=35) |p-value |

|5-yr DFS rate |92% |87% |NS |

|5-yr OS rate |98% |94% |NS |

conclusions = for pt with favorable clinical stage IA-IIA HD, VBM x 6 + IF RT is equivalent to STLI

N Nissen, et al. Cancer Treat Rep. 66:799-803, 1982. – Danish LYGRA II

prospective randomized trial

327 pt with HD

randomization: (1) MOPP + IF RT

(2) STLI

RJ Klasa, et al. Proc Am Soc Clin Oncol. 13:372, 1994. – Vancouver

120 pt with stage IA-IIA HD

ABVD x 2

EF RT

40 mo f/u

RFS = 100%

OS = 96%

V Bonfante, et al. Proc Am Soc Clin Oncol. 13:373, 1994. –

Chemo + IF RT vs Chemo + EF RT

( for CS I-II Hodgkin’s dz, IF RT appears sufficient after 6 cycles of chemo

for CS I-II Hodgkin’s dz, IF RT may be sufficient after 4 cycles of chemo, but longer follow-up is needed

Overall randomized trials have shown that reduction in field size does not compromise outcome

( Engert et al. JCO 2003. HD8

Lymphoma Articles\HD\HD rand trial of EFRT vs IFRT JCO 2003.pdf

German HD group

1204 pts randomized trial

Eligibiltiy: Stage I-II with one or more risk factors. Stage IIIA with no risk factors

Risk factors:

1. LMA

2. Extranodal disease

3. Splenic Involvment

4. ESR > 50 and – B sympt

5. ESR > 30 and + B symptoms

6. > 3 LN areas involved

IIB allowed if only increase in ESR or > 3 LN involved with no other risk factors

Randomized to

1. COPP/ABVD x 2 (total 4) ( EFRT (30 Gy then boost of 10 Gy to bulky disease)

2. COPP/ABVD x 2 (total 4) ( IFRT (30 Gy then boost of 10 Gy to bulky disease)

IF defined as the involved regions at diagnosis

EFRT defined as IF fields at dx + adjacent non-involved sites

Median f/u was 55 months

| |EFRT (40 Gy) |IFRT (40 Gy) |

|CR |98% |97% |

|DFS |86% |84% |

|OS |91% |92% |

Acute SE much higher with the EFRT

Secondary Malignancies on short f/u not different between the 2 arms

Conclusion: Recommend following 4 cycles of chemotherapy, IFRT

( L Viviani, et al. Proc of ASCO. 20: 281a (#1120), 2001, - ? Milan trial

prospective randomized trial

136 pt with clinical stage IB, I bulky, IIA, IIA bulky, or IIEA HD treated between 1990-96

randomization: (1) ABVD x 4 + STNI

(2) ABVD x 4 + IF RT

RT: 30 Gy to uninvolved sites

36 Gy to involved sites

median f/u = 87 mo

| |ABVD + STNI |ABVD + IF RT |p-value |

|CR rate |100% |97% | |

|FFP rate |97% |94% | |

|OS rate |93% |94% | |

conclusions = ABVD x 4 + IF RT can achieve results comparable to ABVD x 4 + STNI

Zanini, et al. Proc 37th ASTRO. #281, 1995. – Milan Trial

prospective randomized trial

114 pt with stage IA-IIA HD

randomization: (1) ABVD x 4 + EF RT

(2) ABVD x 4 + IF RT

38 mo f/u

RFS = 94%

OS = 100%

French Cooperative Trial

on-going

MOPP x 3 ( RT ( MOPP x 3

randomization: (1) EF RT

(2) IF RT

Chemo + IF RT – choice of chemo regimen

( ABVD is at least as efficacious as MOPP or MOPP-like regimens & has markedly reduced risk of leukemia

( P Carde, et al. J Clin Onc. 11:2258-2272, 1993. – EORTC H6U

prospective randomized trial

578 pt with supradiaphragmatic clinical stage I-II HD treated between 1982-88

eligibility criteria: age 15-60 yr, WHO PS 0-2

staging: ESR, CxR, LAG, BM biopsy, CT chest/abd

unfavorable group (H6U): > 3 nodal sites, bulky mediastinum, B-symptoms + ESR > 30 or no B-symptoms + ESR > 50

no staging lap

(1) MOPP x 3 + mantle RT 35 Gy + MOPP x 3

(2) ABVD x 3 + mantle RT 35 Gy + ABVD x 3

| |MOPP |ABVD |p-value |

|6-yr DFS rate |76% |88% |0.01 |

|5-yr OS rate |88% |89% |NS |

|pulmonary toxicity |2% |12% | |

|hematologic toxicity requiring discontinuation of chemo |15% |7% | |

|gonadal toxicity | | | |

central path review

end-points: OS, RFS, CSS

median f/u = 5.3 yr

CR rate = 98%

| | |6-yr RFS rate |6-yr OS rate |6-yr CSS rate |p-value |

|Overall | |81% |89% |92% | |

|initial CR patients | |83% | | | |

|Stage |CS IA |87% |93% | | |

| |CS IB |81% |91% | | |

| |CS IIA |81% |89% | | |

| |CS IIB |74% |84% | | |

conclusions = for unfavorable CS I-II HD (>3 nodal sites, bulky dz, B-sx, ESR > 50), ABVD x 6 + mantle RT produces superior

outcome compared to MOPP x 3 + mantle RT, and staging lap is not necessary

( EM Noordijk, et al. Ann Oncol. 5:S107-S112, 1994. – EORTC H7U

605 pt with supradiaphragmatic clinical stage I-II HD treated between 1988-

6 prognostic factors to form treatment groups

unfavorable group (H7U): 316 pt

> 1 of the following: age > 50, >4 nodal sites, bulky med dz, no B-sx + ESR > 50, B-sx + ESR > 30

randomization: (1) EBVP x 6 + involved-field RT

(2) MOPP/ABV x 6 + involved-field RT

| |EBVP x 6 + IF RT |MOPP/ABV x 6 + IF RT |p-value |

|3-yr RFS rate |72% |88% |0.001 |

|3-yr OS rate |92% |92% |NS |

EBVP: Epirubicin

Bleomycin

Vinblastine

Prednisone

conclusions = unfavorable group (>4 involved nodal sites, bulky mediastinal dz, age>50, no B-sx + ESR>50, B-sx + ESR>30) should

receive MOPP/ABV x 6 cycles + IF RT

ECOG HD11

on-going

randomization: (1) ABVD x 6 + IF RT

(2) Stanford V x 12 wk + IF RT

GHSG HD11

on-going

randomization: (1) ABVD x 4

(2) BEACOPP x 4

2nd randomization: (1) IF RT 20 Gy

(2) IF RT 30 Gy

bulky sites will not receive a boost dose

Chemo + IF RT – how much chemo?

( there is data suggesting that 4-6 cycles of chemo are sufficient to control occult abdominal dz in most pt with CS I-II

however, the optimal extent of RT fields with less than 4 cycles of chemo is uncertain

EORTC H8U

on-going trial

unfavorable group (H8U):

randomization: (1) ABVD x 4 cycles + IF RT

(2) ABVD x 6 cycles + IF RT

GHSG HD10

on-going trial (1998-present)

assessing optimal # of cycles of chemo with IF RT & RT dose

randomization: (1) ABVD x 2 + IF RT

(2) ABVD x 4 + IF RT

2nd randomization for pt in a cCR after chemo: (1) 20 Gy IF RT

(2) 30 Gy IF RT

Chemo + IF RT vs Chemo

• Tried in European study and in POG study

• Both Closed early b/c increased relapses without the RT

EORTC H9F

on-going

CS I-II HD with favorable prognostic factors

all pt receive EBVP II x 6 cycles

randomization for pt in a cCR after chemo: (1) IF RT 36 Gy

(2) IF RT 20 Gy

(3) no RT

- Note Study Closed with no RT arm b/c increased number of relapses

CALGB/SWOG

on-going

randomization: (1) ABVD x 6

(2) ABVD x 4 + IF RT

MSK

on-going trial

CS I-IIIA

all pt receive ABVD x 6

randomization of pt in a cCR after chemo: (1) mantle RT 36 Gy

(2) no RT

STAGE IA, IB, IIA, & IIB SUPRADIAPHRAGMATIC HODGKIN'S DISESASE

Age > 16 yr

Bulky Disease &/or Extensive Pericardial Disease

( Bulky Mediastinal Disease:

combined modality therapy

unacceptably high rate of relapse with radiation therapy or chemotherapy alone

ABVD x 6 cycles (CR + 2 cycles)

IF RT to 36 Gy (modified mantle field)

- reduced RT dose is under study, esp. for pt with CR after chemo (Duke, U of M)

RT Alone

RT Hoppe, et al. Blood. 59:455-465, 1982. - Stanford University

PJ Schomberg, et al. Cancer. 53:324-328, 1984.

GA Gomez, et al. Am J Clin Oncol. 7:65-73, 1984.

( MJ Crnkovich and RT Hoppe, et al. J Clin Onc. 4:472-479, 1986. - Stanford University

Chemotherapy Alone

G Bonadonna, et al. Cancer Surv. 4:439-458, 1985.

S Pavlovsky, et al. J Natl Cancer Inst. 80:1466-1473, 1988.

Chemotherapy + RT

NT Leslie, et al. Cancer. 55:2072-2078, 1985.

( DL Longo, et al. J Clin Oncol. 9:227-235, 1991. - NCI

retrospective study

188 pt with HD treated with MOPP chemotherapy between '64-'76

49 pt with bulky mediastinal disease (mediastinal mass ratio > 1/3)

staging evaluation = LAG; Gallium scan; CxR; radionuclide scans of liver, spleen, and bone; bone marrow biopsy

no staging lap

90% were stage III or IV

10 pt (20%) received mantle RT after chemo -- ?dose

end-points = DFS and OS

factors analyzed for prognostic significance = treatment, stage, B symptoms, sex, age, histology

median f/u = 20 yr

| |bulky mediastinal disease (n=49) |no bulky disease (n=139) |

| |MOPP alone (n=39) |MOPP + RT (n=10) |p-value |MOPP alone |

|complete response rate |67% |90% | | |

|relapse rate for CR pt |50% |11% | | |

|20-yr DFS rate |50% |90% |0.053 | |

|20-yr tumor mortality |54% |20% |0.055 |40% |

conclusions = disease-free survival and tumor mortality is significantly improved with combined modality therapy over

chemotherapy alone for bulky mediastinal dz

( RA Behar, et al. IJROBP. 25:771-776, 1993. - Stanford University

retrospective study

48 pt with clinical stage IA-IIIA HD + bulky mediastinal disease treated with combined modality therapy between '80-'88

staging evaluation = CBC, ESR, serum Cu++, LFTs, CxR, CT chest/abdomen/pelvis, LAG, bone marrow biopsy

10 pt underwent staging lap

mean mediastinal mass ratio = 0.46 (range 0.35-0.85)

stage = I-IIA in 18 pt; IIB in 15 pt; IIIA in 15 pt

treatment = chemotherapy -- MOPP in 15 pts, ABVD in 14 pts, PAVe in 19 pts

radiation therapy -- mantle +/- infradiaphragmatic field (after completion of chemo)

shrinking field technique -- 15-20 Gy ( re-evaluation +/- field change ( mean total 44 Gy

partial transmission lung blocks to deliver 15-18 Gy used in 46% (22 pt)

infradiaphragmatic RT in 37% (18 pt)

88% sandwich technique = 2-4 cycles chemo ( 2-4 wk break ( mantle RT ( chemo (total of 6 cycles)

median f/u = 52 mo

end-points = freedom from relapse, survival

90% complete response rate

9-yr actuarial FFR rate = 84%

9-yr actuarial OS rate = 88%

no significant difference in outcome among different chemo regimens or whether staging lap was performed

complications = 25% hypothyroid; 17% herpes zoster; 15% mild radiation pneumonitis; 4% pericarditis

conclusions = with 9-yr freedom from relapse rates of 85-90%, combined modality therapy without staging laparotomy and

RT limited to involved areas should be considered standard

Longo, et al. J Clin Onc. 15:3338, 1997.

( L Hughes-Davies, et al. IJROBP. 39:361-369, 1997. - Joint Center University

retrospective study

172 pt with CS IA-IIB HD + bulky mediastinal disease treated between '69-'92

definition of bulky mediastinal disease = > 1/3 width of max thoracic diameter on upright PA CxR

> 10 cm cephalocaudad diameter on chest CT

staging evaluation = bone marrow biopsy, CxR, LAG or abdominal CT, lung tomography or chest CT

57% (98 pt) had staging lap ( 17% (16 pt) of these had abdominal involvement

treatment groups = group 1 (staging lap and treatment with RT alone)

group 2 (staging lap and treatment with chemo/RT)

group 3 (no staging lap and treatment with chemo/RT)

pt characteristics = group 1 had significantly less B symptoms, more extranodal extension, & more infradiaphragmatic dz

RT = group 1 & 2: mantle field ( paraaortic/splenic pedicle field

group 3: mantle field only in 95%

dose = 30 Gy + boost to 40 Gy in areas of gross disease

15-16 Gy lung dose if parenchymal lesions or extensive hilar adenopathy

15-16 Gy heart dose if extensive pericardial disease or apical cardiac adenopathy

chemo = MOPP x 6 cycles in 82%

ABVD or ChlVPP in the remainder

sequencing was variable = group 1 & 2: > 2 cycles chemo ( RT ( chemo

group 3: > 90% had 6 cycles chemo ( RT

end-points = freedom-from relapse (FFR) and overall survival (OS)

| |RT alone |Chemo/RT |p-value |clinically staged |pathologically staged |p-value |

|10-yr actuarial FFR rate |54% |88% |0.001 |84% |74% |NS |

|10-yr actuarial OS rate |84% |89% |NS |87% |87% |NS |

|pneumonitis rate |11% |17% |NS | | | |

pattern of failure = 54% in mediastinum

median time to relapse = 1.5 yr

pneumonitis rate was higher when any part of chemo was given after RT vs all chemo given before RT (29% vs 13%, p=0.1)

conclusions = patients with clinical stage I-II supradiaphragmatic Hodgkin's disease with bulky mediastinal involvement do

not require staging lap and combined chemoradiotherapy significantly decreases local recurrence risk.

JE Elconia, LR Prosnitz, et al. IJROBP 45 (suppl): abstr 135, 1999 - Duke and Yale

retrospective

71 with HD and bulky (> 1/3 thoracic diameter) mediastinal disease treated with combined modality therapy (1983-1997)

work-up: PE, CXR, CT chest/abd, LAG, blood chemistries (staging lap performed in 4 pt; Gallium scan in 44 pt)

staging: IA-3, IB-1, IIA-22, IIB-26, IIIA-3, IIIB-6, IVA-2, IVB-8

treatment: induction chemo (various regimens used) x 6 cycles ( re-staged

- 66 pt had a CR: no residual radiologic abnormality or negative Gallium in face of abnormal x-ray / CT

- 5 pt had induction failure

RT: all sites of initial involvement in CR pt to 18.6-43 Gy (AP/PA, 6 MV, 150-180 cGy/fx)

median f/u = 6.4 yr

| |# pt |5 yr OS |5 yr FFS |10 yr OS |10 yr FFS |

|all pt with CR |66 | |78.8% | | |

|RT = 30 Gy |9 | |66.7% | | |

|all pt |71 |93% |76% |76% |74% |

no significant difference in failure rate between dose groupings

of 14 CR pt who had a recurrence: 7 were in field only, 3 were out of field only, and 4 with in and out of field

conclusion = low dose RT following CR to induction chemo may be as effective as high doses in patients with bulky mediastinal dz

STAGE IA, IB, IIA, & IIB INFRADIAPHRAGMATIC HODGKIN'S DISEASE

- 10% of cases

- male predominance

Stage IA-IIA Inguinofemoral +/- Pelvic Disease, Non-Bulky

( ( LAG

( abd/pelvic CT to evaluation liver, spleen, celiac, mesenteric nodes

( BM biopsy

( ABVD x 4

IF RT

field = IF RT

dose = (CR) 3060 cGy

(PR) 3600 cGy

( Staging Lap if considering RT alone (40% splenic involvement)?? ( if (-), then …

EF RT alone

field1 = inverted-Y field + spleen

dose1 = 3600 cGy in 180 cGy fx

2 wk break

field2 = mantle

dose2 = 3060 cGy in 180 cGy fx

( Stage IA LP histology with non-bulky inguinofemoral disease only may be adequately treated with RT alone

(but don’t do it on the boards)

( LAG

( abd/pelvic CT to evaluation liver, spleen, celiac, mesenteric nodes

no staging lap

no BM biopsy

RT alone

field = inverted-Y field +/- spleen

dose = 3600 cGy in 180 cGy fx

Stage IA or IIA Para-aortic Node Disease, Non-Bulky

( ( BM biopsy

if (-)BM, treat like stage III b/c 40% risk of splenic dz

( can’t do extended-field RT alone b/c this would be total nodal RT

( ABVD x 4

IF RT

field = IF RT

dose = (CR) 3060 cGy

(PR) 3600 cGy

Stage IB or IIB or Bulky Disease

( ( LAG

( abd/pelvic CT to evaluation liver, spleen, celiac, mesenteric nodes

( BM biopsy

no staging lap

( ABVD x 4-6

IF RT

field1 = inverted-Y

dose1 = (CR) 3060 cGy

(PR) 3600 cGy

field2 = bulky disease

dose2 = (CR or PR) 3600 cGy

Z Liao, et al. IJROBP. 41:1047-1056, 1998. – MD Anderson

retrospective study

87 pt with stage I-II infradiaphragmatic HD treated between 1962-95

path reviewed

staging evaluation: CxR, BM biopsy, LAG, LAP, CT abd/pelvis

definition of bulky dz = > 7 cm

treatment: RT alone 60 pt

chemo alone 4 pt

chemo x 2-3 cycles + RT (bulky dz, B-symptoms) 23 pt

chemo regimen: MOPP

NOVP

ABVD

RT: field: IF (initial anatomic location of the adenopathy) 14 pt

pelvic (iliac and inguinofemoral nodes) 7 pt

inverted-Y (paraaortic, iliac, and inguinofemoral nodes) 12 pt

inverted-Y + spleen 7 pt

total abdomen (upper 2/3 abdomen, iliac, and inguinofemoral nodes) 34 pt

central lymphatic irradiation (mantle + total abdomen) 6 pt

paraaortic + spleen 1 pt

dose: median = 30 Gy

range = 25-45 Gy

CR rate = 98%

median time to relapse = 15.5 mo

median f/u = 15 yr

| | |relapse rate* |10-yr OS rate |10-yr DFS rate |

|overall | | |75% |72% |

|stage |IA |10% | | |

| |IIA |29% | | |

| |IIB |46% | | |

|treatment |RT alone |22% | | |

| |chemo alone |25% | | |

| |chemo + RT |44% | | |

*16 of 24 relapses occurred above the diaphragm

3 relapses occurred in the RT field

factors analyzed: age, gender, stage, B-symptoms, histology, bulky dz, # sites, Hb, albumin, LDH, treatment

UVA: predictors of ( OS = age > 40 yr, B-symptoms, MC or NS histology (compared to LP), Hb < 12, albumin < 3.5

predictors of ( DFS = # involved sites > 3, stage II, B-symptoms, albumin < 3.5, treatment

MVA: predictors of ( OS = age > 40 yr RR 5

Hb < 12 RR 3.4

NS or MC RR 5 vs LP

predictors of ( DFS = albumin < 3.5 RR 12.8

chemo + RT RR 3.6

M Hull, N Mendenhall, et al. IJROBP. 52:161-166, 2002. – U of Florida

retrospective study

21 pt with stage I-II subdiaphragmatic HD treated with curative intent between 1966-98

median f/u = 12.3 yr

10-yr OS rate = 70%

10-yr PFS rate = 80%

recommendations:

cIA inverted-Y + spleen

cIIA, NS/LP inverted-Y + spleen

pIA inverted-Y

pIIA inverted-Y

cI-II, > 3 nodal sites, B-symptoms, bulky dz (> 6 cm), central (para-aortic) presentation, splenic involvement chemo + RT

STAGE III HODGKIN'S DISEASE

Age > 16 yr

( 5-yr OS rate = 75%

5-yr RFS rate = 70%

80% for stage IIIA with minimal (< 5 nodules) or no splenic involvement

- Prognostic Factors for stage III and IV

stage IV

male sex

age ( 45 yr

leukocytosis (WBC count > 15,000)

lymphocytopenia (lymphocyte < 600)

Hb < 10.5 g/dl

serum albumin level < 4 g/dl

( NEJM. 339:1506, 1998. –

MVA of prognostic factors for stage III-IV HD

7 factors identified: stage IV, male gender, age > 45 yr, WBC > 15,000/cc, ANC < 600/cc, Hb < 10.5 g/dl, albumin < 4 g/dl

|# of adverse factors |5-yr OS rate |

|0-3 |83% |

|4-7 |59% |

Clinical Stage IIIA or IIIB, Non-Bulky or Bulky

( chemotherapy is standard and consolidation RT is controversial

rational approach b/c most relapses occur in sites of initial disease

realize that BMT is more difficult after prior thoracic RT – ( bone marrow reserve & ( pulmonary toxicity

Up to 20% of pts with advanced stage HD fail to CR to chemotherapy

( ABVD x 6-8 cycles (CR + 2 cycles) +/- Consolidation RT

or BEACOPP high dose X 8 cycles

re-stage after 4 cycles & 6 cycles with CT of initially involved areas and gallium scan or PET scan

if give more than 6 cycles, bone marrow reserve is reduced, thus hindering chance for BMT if necessary

6 cycles ( non-bulky ( cCR ( +/- 2 additional cycles of chemo

cSD/PD (+PET)( BMT

cPR ( IF RT (30 – 36 Gy) vs BMT

bulky ( cCR ( +/- 2 additional cycles of chemo

cSD/PD (+PET) ( BMT

cPR ( IF RT (30 – 36 Gy) vs BMT

consolidation RT is controversial

indications: PR after chemotherapy (vs BMT?) 30 – 36 Gy

or not treated to 2 cycles past CR?? – personal indication

field = initially involved nodal sites – (off protocol consider only sites of initial bulky dz)

dose = 20 Gy in 1.8 Gy fx

• Pt refuses Chemo

Per PC- if bulky Mediastinal disease would treat whole lung with transmission blocks (37%) would allow for 40 Gy to mantle and 1500 cGy to lungs

( Peripheral Stem Cell Transplant

clear indications: refractory to standard chemo

early relapse < 1 yr

( NCCN Guidelines:

ABVD x 4 cycles ( re-stage with CT of all initially (+)sites

CR/PR ( ABVD x 2 cycles (6 total) +/- IF RT 20-36 Gy

stable/minimal response ( Gallium scan ( (-) ( ABVD x 2 cycles (6 total) + IF RT

(+) ( biopsy ( high-dose chemo +/- IFRT + peripheral stem cell

transplant

progression ( biopsy ( high-dose chemo +/- IF RT + peripheral stem cell transplant

Pathologic Stage III (CS I-II with (+)staging lap)

( ABVD x 6-8 cycles +/- IF RT

STAGE IV HODGKIN'S DISEASE

( BEACOPP high dose X 8

ABVD x 6-8 cycles

+/- IF RT for complete responders (see NCCN guidelines for stage III)

if Gallium scan is still (+), then chemo resistant disease and RT is unlikely to convert pt to CR ( needs BMT

( Pediatric Patients:

- chemotherapy alone vs combined therapy with low dose radiation (15-25 Gy) to limit growth retardation

- whole lung RT for pulmonary mets ??

mantle field with partial transmission blocks for lungs (inferiorly to T12 to cover all lung volume)

dose = ~ 10 Gy for kids (ie. 50% transmission blocks b/c total mantle dose = 21 Gy)

~ 12 Gy for adults (ie. 33% transmission blocks b/c total mantle dose = 36 Gy)

Choice of Chemo Regimen

• High dose BEACOPP current standard of care based of randomized trial comparing COPP/ABVD vs BEACOPP vs High dose BEACOPP

• Stanford 5

12 week dose-intensive regimen

Cumulative dose of alkylating agents is only 25% that of MOPP

Adriamycin dose 50% of ABVD and bleo is 25% of ABVD

- Note, I believe all trials with Stanford 5 have included 36 Gy IF RT to sites >5 cm

( GP Canellos, et al. NEJM. 327:1478-1487, 1992. - CALGB Trial

prospective randomized trial by CALGB

361 pt with stage III-IV HD and those with relapse after RT alone randomized to MOPP vs ABVD vs MOPP/ABVD.

eligibility criteria = age > 16 yr, adequate renal function and bone marrow reserves

24% had staging lap

stratification by age, stage, histology, previous RT, performance status, presence of mediastinal mass

randomization: (1) MOPP -- q28days until CR, then 2 additional cycles (minimum = 6 cycles; maximum = 8 cycles)

(2) ABVD -- q28days until CR, then 2 additional cycles (minimum = 6 cycles; maximum = 8 cycles)

(3) MOPP/ABVD -- MOPP alternating with ABVD for 12 cycles

for MOPP and ABVD groups, if stable or progressive disease after 2 cycles or < CR after 6 cycles ( alternative regimen

no adjuvant RT

response evaluated after every 2 cycles with CxR, bone scan, liver and spleen scans, abdominal x-ray

follow-up = q3mo x yr 1-2, then q6mo thereafter with CxR, bone scan, liver and spleen scan, abdominal x-ray

end-points = failure-free survival (FFS), disease-free survival (DFS), overall survival (OS)

median f/u = 6 yr

| |MOPP (n=123) |ABVD (n=115) |MOPP/ABVD (n=123) |p-value |

|complete response rate |67% |82% |83% |0.006 (MOPP vs others) |

|5-yr failure-free survival |50% |61% |65% |0.02 (MOPP vs others) |

|5-yr overall survival |66% |73% |75% |NS |

MVA: factors significantly affecting CR rate = age (67% for age > 50 yr; 80% for age < 50 yr)

performance status (52% for PS 2; 80% for PS 0-1)

B symptoms (73% vs 84%)

liver involvement (65% vs 79%)

factors significantly affecting FFS rate = age, chemo regimen, stage, > 1 extranodal site involved

prognostic groups: low risk group = age < 50 yr, stage III or IV with one extranodal site involved ( 5-yr FFS = 70%

high risk group = age > 50 yr, stage IV with > 2 extranodal sites involved ( 5-yr FFS = 45%

toxicity: MOPP -- severe neutropenia in 50% and life-threatening in 25%

ABVD -- severe neutropenia in 18% and life-threatening in 3%; severe pulmonary toxicity in 6%

salvage after failure: CR rate = 35% for those who failed MOPP and 61% for those who failed ABVD

conclusions = ABVD and MOPP/ABVD are superior to MOPP in achieving complete remission and failure-free survival

in those with stage III-IV Hodgkin's disease

Duggan et al. JCO 2003

Phase III trial of pts with adv HD disease 856 pts included

Eligibility: IIIA, IIIB, or IV or pts with relapse s/p RT alone

Randomized to

1. ABVD

2. MOPP/ABV

|Treatment |CR |FFS |OS |2nd Malig |

|ABVD |76% |63% |82% |18 total |

|MOPP/ABV |80% |66% |81% |28 total |

ABVD associated with equivalent OS with less 2nd malignancies

( Diehl et al. NEJM 2003

Phase III trial with 1201 pts included

Eligibility: IIB or IIIA with Large Mediastinal Mass

IIIA with ESR > 50 or ESR > 30 with B symptoms, or > 3 LN areas involved

IIIB or IV

- essentially high risk III and IIIB any, IV any

Randomized pts to

1. ABVD/COPP (8 total cycles) – stopped early at interim analysis b/c poor results

2. BEACOPP (Standard dose)

3. BEACOPP Dose increased with Neuopen support

- Bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, Procarbazine, Prednisone

Pts were restaged s/p 4 cycles

RT given to sites > 5 cm (30 Gy) or residual masses (active) 40 Gy

| |COPP/ABVD (260 pts) |Standard BEACOPP |High dose BEACOPP |P value |

|Progression on chemo |10% |8% |2% |Sig for high dose BEACOPP|

|CR |85% |88% |96% | |

|5 yr FFF |69% |76% |87% |Sig for high dose BEACOPP|

|5 yr OS |83% |88% |91% |0.002 vs ABVD COPP |

| | | | |0.06 vs Stand BEACOPP |

Conclusion: High dose BEACOPP had improved FFF and almost significantly improved OS compared to standard BEACOPP.

Consider BEACOPP high dose for this patient population

Federico et al ASCO 2004 – Italy

Randomized trial of 355 pts comparing 3 different chemotherapy regimens

Eligibility: Stage IIB – IV Hodgkins

Randomized to

1. ABVD x 6 cycles

2. MOPP-EBV-CAD

3. Stanford 5

RT: Delivered to residual masses or to the sites of previous bulky disease

Results

| |ABVD |MOPP/EBV/CAD |Stanford 5 |Pvalue |

|CR |88% |94% |72% |0.01 |

|5 yr PFS |83% |85% |67% |>0.01 |

|5 yr OS |90% |90% |83% |NS |

Conclusion: Show an advantage of ABVD and MEC over Stanford V

Chemo + RT vs Chemo

• Indications for RT in Stage III-IV disease

1. PR s/p all chemo

2. ? Did not give 2 cycles past CR?

for stage III-IV HD who achieve a CR after chemo, would not recommend RT if 2 cycles past CR given

- Previously, RT shown to improve EFS. However, several randomized trials have not shown a beneficial role for RT s/p chemotherapy

o Studies have taken 2 approaches

1. Same chemo with observation vs consolidation RT

Usually shows improved EFS with consolidation RT

OS usually equal

2. Different chemo with essentially RT instead of chemotherapy

Usually shows equivalent DFS and OS

- If RT used, recommend 20 Gy to IF for CR pts and 36 Gy for PR

• Relapses occur in about half of the advanced stage pts who achieve CR with chemo alone

• Meta-analysis done showing no benefit and what many quote

- only 6 of the 14 trials were included

- 2 different “designs” seen

• Largest trial done in US is SWOG trial

- Poorly done in that not all randomized to RT actually received it, but was improvement in DFS – as treated

• German study 2nd largest study and was a design where chemo given and then CR randomized to further chemo or RT IF. No benefit seen for RT arm

• Argentine trial done with II/IV HD but all were randomized, not just those in CR, and therefore, the CMT group has improved FFS compared to CT alone pts

• Pediatric study randomized IIB, III, and IV HD to 8 cycles of ABVD +/- IF RT and found no benefit with intent to treat, but the as-treated analysis showed superior outcome for the RT group

• CCG trial compared 12 cycles of MOPP/ABVD to 6 cycles of ABVD + EF RT and a non significant improvement in OS and FFS in CMT group

• Recent CCG trial randomized pts with COPP/ABV and CR randomized to RT vs no RT

- trial close early b/c increased FFS without the RT

• Largest trial was EORTC which gave 4 cycles of chemotherapy and then restaged. IF CR then 2 more cycles. If PR 2 more cycles then restage at 6. Needed to treat 2 cycles past CR and then randomized to IF RT. No benefit for the RT

( Nachman, et al. – CCG 5942 Rand trial of IFRT vs no RT for HD with CR to chemo. JCO 20: 3765-3771 2002Lymphoma Articles\HD\Peds HD Rand trial of CR to RT vs no RT.pdf

closed early due to excessive failures in chemo alone arm. Open from ’95 to ’98

829 pts with Pediatric HD (/=4 LN regions, Mediastinal dz > 1/3 thorax, >10 cm peripheral mass

Group 1 pts: Stage I without adverse features and IIA without adverse features

Group 2 pts: Stage I with adverse features and Stage II with adverse features or B symptoms, and Stage III pts

Group 3 pts: IV pts

chemo: Group 1--stage I, IIA non-bulky, < 4 sites, no hilar dz (alternating 2 COPP & 2 ABV)

Group II--stage I, IIA bulky or IIB-III (alternating 3 COPP & 3 ABV)

Group III--stage IV (Ara-C/VP-16, COPP/ABV, CHOP x 2)

if CR, randomized to (1) IF RT – 2100 cGy in 175 cGy fx

(2) no RT

if PR, then IF RT to 3500 cGy in 175 cGy fx

Note if IV disease with pulmonary involvement, pts received 10.5 Gy to lungs in 12 fractions

if < PR, then off study

CR- If incomplete radiologic response in mediastinum, could still have CR if >70% reduction and gallium – if prev +

PR- defined as 50-70% reduction in TV

Overall 650 pts had CR and eligible for randomization. Only 501 pts were randomized, most off protocol were observed

| |COPP/ABV x 4 (n=245) |COPP/ABV x 4 + IF RT (n=249) |p-value |Group 1 |Group 2 |Group 3 |

|3-yr EFS rate (for |87% |92% |0.57 |95% |82% |83% |

|CR) | | | | | | |

|3 yr EFS as treated |85% |93% |.0024 | | | |

|3-yr OS rate |98% |99% |NS | | | |

Median time to relapse for chemotherapy with observation was 6 months, and most 29/34 were in sites of known disease. Median time for relapse in IFRT was 14 mo with 7/12 occurred within in field only. Post relapse survival was better for rand pts who relapsed after chemo alone compared with those who relapsed after combined therapy (94% vs 84%). This improvement in EFS was seen in all stages treated. In addition, when analyzed by treatment actually received, those with RT did even better. Therefore, combination treatment has remained the standard of care

( J Raemaekers, et al. Ann Oncol. 8:S111-S114, 1997. – EORTC 20884 Trial

update in B Aleman, et al. Proc of ASTRO. 51(suppl 1): 2, 2001.

Update NEJM 2003

prospective randomized trial

Eligibility: III-IV HD (but not IIIAs)

736 pt with CS III-IV HD s/p 6-8 cycles of MOPP/ABV (CR + 2 cycles, 6 if CR after 4, 8 if CR after 6)

pt char: 35% bulky dz

42% stage IV

pt with CR (60%) were randomized: (1) no further therapy

(2) IFRT

RT: 24 Gy to all initially involved nodal areas

16-24 Gy to all initially involved extranodal areas

Note- lower CR rate than normally noted

pt with PR (35%) after 6 cycles - RT to all initially involved nodal (30 Gy) & extranodal (18-24 Gy +/- 4-10 Gy boost) sites

5% failed to respond

median f/u = 79 mo

| |CR – no RT (n=161) |CR – RT (n=172) |p-value |PR – RT (n=243) |

|5-yr RFS rate |84% |85% |NS | |

|5-yr EFS rate |84% |79% |NS |79% |

|5-yr OS rate |91% |85% |0.07 |87% |

|Death 2nd Malig |25% |39% | | |

|Death from |6% |18% | | |

|intercurrent | | | | |

|disease | | | | |

|5 yr cumulative |4% |7.8% |0.05 | |

|2nd malign rate | | | | |

|Liquid tumor |17% |53% | | |

Conclusions: IF RT did not improve outcome in pts with Stage III-IV HD after CR to 6-8 cycles of MOPP/ABV chemotherapy.

RT may benefit those pts with PR

( CJ Fabian, et al. Ann Intern Med. 120:903-912, 1994. - SWOG 7808

prospective randomized trial – total 530 pts entered, 322 achieved CR, 278 randomized

278 pt with clinical stage III-IV HD

- only 104/135 pts randomized to RT actually received it

all had CR after MOP/BAP chemo

randomization: (1) chemo + IF RT (23% did not receive RT)

(2) chemo

RT: field = involved nodal sites

dose = 2000 cGy

field = involved extranodal sites

dose = 1000-1500 cGy

actual treatment received analysis:

| |Chemo + RT |chemo |p-value |

|5-yr DFS rate |85% |67% | |

Pts who had PR all received RT without randomization and FFS and OS was identical to those getting chemo/RT

conclusions = RT in addition to chemotherapy improved the DFS but not the OS

( V Diehl, et al. Proc Am Soc Clin Oncol. 1057:273, 1990. - German HD-3 Trial

prospective randomized trial

274 pt with stage IIIB-IV HD

induction chemo = COPP/ABVD x 6 mo

pt with CR were randomized: (1) COPP/ABVD x 2 mo

(2) IF RT to 20 Gy

| |COPP/AVBD x 6 + IF RT 20 Gy |COPP/ABVD x 8 |p-value |

|5-yr OS rate |93% |80% | |

|5-yr RFS rate |80% |79% | |

conclusions = for stage IIIB-IV HD after achieving a CR with 6 cycles of chemo, addition of IF RT to 20 Gy improves survival

compared to 2 additional months of chemo

( Ferme, et al. Blood. 95:2246, 2000. – GELA H89

prospective randomized trial

559 pt with advanced HD

1st randomization: (1) MOPP/ABV x 6 cycles

(2) ABVPP

pt in cCR or good cPR, randomized to (1) chemo x 2

(2) SNTI

median f/u = 48 mo

| |MOPP/ABV x 8 |MOPP/ABV x 6 + STNI |ABVPP x 8 |ABVPP x 6 + STNI |p-value |

|5-yr DFS rate |80% |82% |68% |75% |0.01 |

|5-yr OS rate |85% |88% |94% |78% |NS (MOPP/ABV) |

| | | | | |0.002 (ABVPP) |

( NL Bartlett, et al. J Clin Onc. 13:1080, 1995. & Horning, et al. J Clin Onc. 20:630-637, 2002. – Stanford University

142 pt with stage II with bulky mediastinal involvement (n=__) or stage III-IV (n=__) HD treated between 1989-

Stanford V + RT to areas of PR or initial bulk > 5 cm

Stanford V: q1wk x 12 wk

Adriamycin

Vinblastine

Mechlorethamine

Vincristine

Bleomycin

Etoposide

Prednisone

initial 25 pt received RT to initial bulky disease or residual radiographic abnormalities after chemo

final 117 pt received RT only to bulky disease (> 5 cm or macroscopic splenic nodules on CT)

RT: field = IF

dose = 36 Gy

median f/u = 5.4 yr

| |overall |stage II with LMA |stage III-IV |p-value |IPI score 0-2 |IPI score > 3 |p-value |

|3-yr OS rate |96% | | | | | | |

|5-yr OS rate |96% | | | | | | |

|3-yr FFS rate |87% |100% |82% | | | | |

|5-yr FFS rate |89% | | | |94% |75% |< 0.0001 |

no pt progressed during treatment

no treatment-related deaths

female and male fertility appears to be preserved

no secondary leukemia was observed

Horning, et al. J Clin Onc. 18:972-980, 2000. – ECOG 1492

multi-institutional phase II pilot study

47 pt with bulky mediastinal stage I-II or stage III-IV HD

Stanford V x 12 wk ( RT 36 Gy to initial bulky nodes (> 5 cm) or macroscopic splenic disease

median f/u = 4.8 yr

5-yr PFS rate = 85%

5-yr OS rate = 96%

ECOG 2496 / Intergroup

on-going

comparing Stanford V to ABVD

J Yahalom, et al. J Clin Onc. 9:2193-2201, 1991. – MSK

retrospective (review of pt treated on 2 protocols)

| | |RT to all initial dz sites |RT to only some of initial dz sites / no RT |p-value |

|10-yr RFS rate |all pt |89% |68% |0.001 |

| |stage II |90% |80% |0.09 |

| |stage III-IV |87% |66% |0.009 |

| |< 5 involved sites |93% |77% |0.005 |

| |> 5 involved sites |73% |59% |0.045 |

|10-yr OS rate |all pt |94% |71% |0.001 |

| |stage II |96% |64% |0.0002 |

| |stage III-IV |92% |72% |0.042 |

| |< 5 involved sites |91% |84% |NS |

| |> 5 involved sites |91% |60% |0.036 |

Loefler, et al. J Clin Onc. 16:818-829, 1998. – Meta-Analysis

meta-analysis of 1,740 pt from 14 prospective randomized trials from 1968-88 (8% I-IIA, 27% IIB-IIIA, 65% IIIB-IVA)

7 trials with 918 pt compared chemo vs. identical chemo + RT

7 trials with 837 pt compared chemo + RT vs. chemo + additional chemo

median f/u = 8.5 yr

| |chemo + RT |chemo |p-value |chemo + RT |chemo + additional chemo |p-value |

|10-yr OS rate |61% |65% | |61% |68% | |

|10-yr DFS rate |62% |51% | |58% |59% | |

KC Marcus, et al. J Clin Oncol. 12:2567-2572, 1994.

J Clin Onc. 18:972, 2000. – Stanford University

Proznit, et al. 1988.

Prizel, et al. 1990. - Intergroup Trial

on-going

ABVD x 6-8 + RT for LMA

GHDSH HD12

on-going

Brizel, et al. IJROBP. 19:535-542, 1991. – Duke University

retrospective study

177 pt with advanced HD

all had chemo

154 pt had cCR ( 87 pt had no RT

67 pt had RT

23 pt had < cCR

|complete responders |chemo + RT |chemo |p-value |

|10-yr OS rate |92% |59% | |

|10-yr DFS rate |87% |56% | |

RECURRENT HODGKIN'S DISEASE

adverse prognostic factors:

initial treatment included chemo vs RT alone

disease free interval < 1 yr

|DFI |salvage rate (without BMT) |

|> 1 yr |50% vs 65% ? |

|< 1 yr |25% |

location of relapse

|location |salvage rate (without BMT) |

|nodal only |50% |

|nodal + extranodal |30% |

Relapse After Chemotherapy:

limited nodal relapse

( RT

- 5 yr DFS approx 30% and OS of 55 - 70%

• Combined non-cross resistant chemotherapy and RT

diffuse relapse > 1 yr after initial therapy

( chemo with non-cross resistant drugs

+/- RT

diffuse relapse < 1 yr after initial therapy

• Several studies including small randomized trials have shown an advantage in DFS and OS for those pts who receive BMT as part of regimen compared to chemotherapy alone

( high-dose chemotherapy and autologous stem-cell support +/- IF RT

20- 30% salvaged after standard dose chemo

55% salvaged after high dose chemo + PSCT

80-100% of failures s/p PSCT are at sites of initial disease ?

- 30-65% OS with Children and BMT

- Some data shows that those with history of atopy and asthma at higher risk of pulmonary problems

- RT is used for IF RT before transplant and reduces risk of relapse at RT sites, also may be used for those who fail to CR to pre-transplant chemotherapy

- Retrospective series have shown improved FFR in pts who received IFRT

- RT doses to IF range from 20 to 36 Gy

M Uematsu, et al. Cancer. 72:207-212, 1993. - Joint Center

retrospective study

28 pt with relapse of HD after combination chemotherapy alone were treated between 1971-90

eligibility criteria = nodal relapse only

75% stage III-IV initially

75% initially treated with MOPP & remainder with ABVD or MOPP/ABVD ( 61% initial CR rate

restaging evaluation = CxR, abd CT or LAG, bone marrow bx

recurrence in a single node in 12 pt (43%)

recurrence in multiple nodes in 16 pt (57%)

treatment = (1) chemo/RT (14 pt): 50% ABVD; 50% MOPP

57% mantle RT; 28% mantle & paraaortic RT; 14% total nodal RT

(2) RT alone (14 pt): 21% mantle RT; 57% mantle & paraaortic-splenic pedicle RT; 21% total nodal RT

**RT dose = 35-44 Gy

end-points = survival & disease-free survival

median f/u = 80 mo

| |RT alone (n=14) |Chemo / RT (n=14) |p-value |

|7-yr actuarial DFS rate |36% |93% |0.002 |

|7-yr actuarial OS rate |36% |85% |0.03 |

conclusions = combination of extended-field RT and chemotherapy is significantly more effective than RT alone for

treatment of nodal only relapse after initial treatment with chemotherapy alone

Lancet. 341:1051, 1993. –

MSK 94-68

re-induction with ICE chemotherapy ( if responding, then IF RT to sites > 5 cm ( PSCT

Relapse After RT Alone

( salvage rate after combination chemo: 10-yr DFS rate = 57-80%

10-yr OS rate = 57-81%

relapse stage I-IIA

( ABVD to CR + 2 cycles (max 6)

( +/- RT

15-25 Gy to previously irradiated sites

30-40 Gy to nonirradiated regions

relapse stage I-IIB, III-IV

( ABVD to CT + 2 cycles (min 6)

( +/- RT

15-25 Gy to previously irradiated sites

30-40 Gy to nonirradiated regions

EA Healey, et al. Cancer. 71:2613-2620, 1993. - Joint Center

retrospective study

127 pt with PS IA-IIIB HD treated between '69-'85 who developed relapse and underwent salvage therapy

initial staging included LAG, CT, CxR, staging lap

initial treatment = RT alone (total nodal RT or extended field RT) in 110 pt (group 1)

Chemo/RT (MOPP) in 17 pt (group 2)

pt characteristics were similar except for initial stage (PS III - 37% vs 76%) and B symptoms (13% vs 76%)

staging at relapse = bone marrow biopsy, CxR, CT chest/abdomen

pattern of relapse by initial treatment group: group I -- nodal sites only in 59%

group II -- nodal sites only in 53%

therapy for relapse:

| |Chemo alone |Chemo/RT |RT alone |

|group 1 |99 pt (90%) |8 pt |3 pt |

|group 2 |13 pt (76%) |3 pt |1 pt |

factors analyzed for prognostic significance:

sex, age (< 40 vs > 40), initial PS (I-II vs III), relapse stage (I-II vs III-IV), histology (NS/LP vs MC/LD),

time to relapse (< 12 mo vs > 12 mo), prior pelvic RT, nodal only vs extranodal +/- nodal relapse,

relapse inside vs outside of RT field

median f/u after relapse = 92 mo

end-points = second CR rate, freedom from second relapse (FSR) rate, overall survival (OS), cause-specific survival (CSS)

| |all pts |group I |group II |p-value |

|second CR rate |79% |82% |59% |0.05 |

|10-yr actuarial FSR rate |53% |58% |13% | |

| - with second CR | |71% |22% |0.04 |

|10-yr actuarial OS rate |57% |59% | | |

| - with second CR | |75% |40% |NS |

|10-yr actuarial CSS rate | |62% |24% | |

UVA: factors favoring a second CR = NS/LP histology, nodal relapse only, no initial pelvic RT, low relapse stage (I-II)

Pediatric Population (age < 16 yr)

Epidemiology

( 6% of childhood malignancies

40% of childhood lymphomas

( male : female predominance

age 3-7 yr 4:1

age 7-9 yr 3:1

age 9-16 yr 1.3:1 (similar to adults)

( peak age = adolescence

rare < 5 yr

Bimodal peak peaking in the 20’s and then after 50 yo

Risk Factors

( h/o infectious mononucleosis ( see ( EBV-Ab titers prior to diagnosis, esp. in MCHD

( affected sibling 2-9 RR for sibling and 99X increased risk for monozygotic twins

Presentation

( painless adenopathy 90%

|nodal region |frequency of involvement |

|cervical |80% |

|mediastinum |75% (adolescents) vs 33% (age 1-10 yr) |

|infradiaphragmatic |5% |

( B-symptoms 33%

Work-up

( H&P

( blood work: CBC, lytes, BUN/Cr, LFTs, Alk phos, ESR, LDH

( CxR

CT chest/abd/pelvis

Gallium (Ga67) scan – rebound thymic hyperplasia can cause abnormal uptake in kids (false +)

( bone marrow biopsy – only if clinical stage III-IV or B-symptoms

( excisional LN biopsy

Natural History

( histology

|histologic subtype |age < 10 yr |age 10-16 yr |age > 17 yr |

|NSHD |44% |77% |72% |

|MCHD |33% |11% |17% |

|LPHD |13% |8% |5% |

|LDHD |0% |1% |1% |

S Cleary, et al. IJROBP. 28:77-84, 1994. - Stanford University

( 60% stage I-II

40% stage III-IV

Prognostic Factors

R Smith, et al. Proc of ASTRO. 119, 2001. – multi-institutional

analysis of pre-tx factors in 320 pt to develop a prognostic index in children with clinical stage I-IV HD between 1990-2000

tx = chemo + low-dose IFRT

median f/u = 53 mo

MVA – 4 factors predicting for ( DFS = male gender; stage IIB, IIIB, or IV; WBC > 11,500, Hb < 11

(insignificant factors = age, histology, B-symptoms, ESR, extranodal dz, bulky dz)

|# prognostic factors |5-yr DFS rate |5-yr OS rate |

|0-1 |94% |96% |

|2 |78% |95% |

|3-4 |63% |77% |

( stage

( bulk of disease

large mediastinal mass

> 4 sites involved

> 5 splenic nodules

stage IV with multiple extranodal organs involved

( B-symptoms

( ( LDH, ESR, ferritin

( age

|Age |5-yr OS rate |10-yr OS rate |

|< 10 yr |94% |92% |

|11-16 yr |93% |86% |

|> 16 yr |84% |73% |

S Cleary, et al. IJROBP. 28:77-84, 1994. - Stanford University

Outcome

( 80% overall survival

|Stage |10-yr OS rate |10-yr DFS rate |

|I-IIA(non-bulky) |~ 97% |~ 93% |

|IIA(bulky), IIB-IIIA |~ 90% |~ 87% |

|IIIB-IV |~ 75% | |

Treatment (p214-216 of peds book)

Stage IA-IIA (non-bulky) – current standard per ASTRO 2001 refresher course is combined modality therapy

( COPP alternating with ABV x 4 cycles

OR

ABVD x 4 cycles

for peds pt, chemo is always involved in tx regimen

chemo + low dose IF RT will result in less late toxicity than with RT alone (bone & muscle hypoplasia)

OR

ABVE-PE x 4 cycles

RT: field = involved nodal areas

Ann Arbor site

Neck: Treat ipsilateral neck and include entire width of vertebral bodies (to prevent any future growth abnormalities)

mediastinal mass – initial CC dimension + 2 cm; post-chemo lateral extent + 1.5 cm; include SCF; exclude axilla is not involved

iliac nodes – perform oophoropexy in females to preserve fertility

pulmonary nodules – may require whole lung RT

dose = (CR) 2100-2550 cGy

(< CR) 3500 cGy

ex. 2001 ASTRO case 1: 13 yo M with high left cervical node (4 cm), Gallium (+)left neck only, CT chest/abd/pelvis(-),

bx = NSHD, CS IA

prognosis – 10-yr DFS = > 90%

tx – ABVD x 4 + IF RT (2 cycles may be appropriate for early rapid responders on protocol)

field – left neck & SCF

if pre-pubertal, consider bilateral necks to ( hypoplasia (esp. if > 25 Gy)

if very high neck node, ( CT neck to r/o nasopharynx involvement

may be difficult to cover upper portion of very high neck dz with AP/PA ( may need lateral mixed

beam field matched to low neck field with common isocenter

if LPHD & completely excised, then tx with chemo + IF RT is still appropriate instead of IF RT alone

as in adults b/c dose required is high

RR of 2nd malignancy = ~ 20 for females & ~ 10 for males

< 10% infertility rate with ABVD

ex. 2001 ASTRO case 2: 9 yo F with left cervical, PA, bilateral iliac nodes (all < 3 cm), B-sx, bx = MCHD, CS IIIB

prognosis – 10-yr DFS = ~ 75%

ABVD + IF RT – while adult studies appear to be (-), CCG 5942 showed ( relapse rate with IF RT

RT field – inverted Y +/- spleen

ex. 2001 ASTRO case 3: 9 yo F with CS IIIB treated with ABVD x 6 but relapses 3 yr later in PA region

tx – high dose chemo + stem cell rescue (could consider RT alone in adult pt relapsing > 1 yr out)

TBI 12 Gy

also add IF RT after stem cell rescue

( Stanford data on transplants in relapsed kids

SS Donaldson, et al. J Clin Onc. 5:742-749, 1987. - Stanford University Ped HD 1 Study

retrospective study

55 pt < 14 yr old treated with MOPP x 6 cycles + low dose IF RT between 1970-83

staging lap in 96%

27 stage I-II & 28 stage III-IV

80% NSHD or MCHD

tx scheme: MOPP x 2 ( RT field#1 ( MOPP x 2 ( +/- RT field#2 ( MOPP x 2

RT: field: supramediastinal mantle (mini-mantle) field for dz limited to axilla, SC, IF, & cervical LNs

full mantle field to dz in thorax and cervical +/- axilla LNs

para-aortic or pelvic fields for infradiaphragmatic dz

dose: bone age (yr) dose (cGy)

< 5 yr 1500

6-10 yr 2000

11-14 yr 2500

? 10 Gy boost to those with < CR or bulky dz (> 6 cm node or LMA)

median f/u = 7.5 yr

| |overall |stage I-II |stage III-IV |

|10-yr actuarial OS rate |89% |100% |78% |

|10-yr actuarial FFR rate |90% |96% |84% |

|10 yr actuarial LC rate |97% | | |

low dose RT resulted in minimal inhibition of soft tissue and bone growth

secondary acute leukemia rate = 4% at 5-yr & 11% at 10-yr

conclusions = MOPP x 6 cycles + low-dose RT provides excellent dz control for pediatric HD

however, majority of males became sterile and secondary leukemia rate was significant

S Hunger, et al. J Clin Onc. 12:2160-2166, 1994. - Stanford University Ped HD 2 Study

57 pt < 16 yr old with HD (1 IA, 22 II, 21 III, 13 IV) treated with ABVD x 3 / MOPP x 3 + IF RT between 1982-90

ineligibility criteria: stage IA LPHD in high neck, treated with RT alone

staging lap in 70%

tx scheme: ABVD x 1 + MOPP x 1 ( RT field#1 ( ABVD x 1 + MOPP x 1 ( +/- RT field#2 ( ABVD x 1 + MOPP x 1

RT: field1 = involved field (most bulky area, usually mantle field)

dose1 = 1500 cGy

field2 = sites of bulky dz (LMA or > 6 cm nodal mass) OR < CR after 2 cycles of chemo

dose2 = 1000 cGy (total = 2500 cGy)

median f/u = 6.7 yr

all pt had CR after completing tx

| |overall |stage I-III |stage IV |p-value |

|10-yr actuarial OS rate |96% |100% |85% |0.02 |

|10-yr actuarial EFS rate |93% |100% |69% |0.0005 |

no second malignancies

no abnormal skeletal growth or pubertal development

no symptomatic cardiac, pulmonary, or thyroid dz

32% subclinical pulmonary dysfunction

16% chemical hypothyroidism

conclusions = alternating ABVD/MOPP x 6 cycles with involved field RT to 15 Gy [10 Gy boost to sites of bulky dz (LMA or

> 6 cm nodal mass) or < CR after 2 cycles of chemo] produces excellent results in pediatric HD stage I-III

O Oberlin, et al. J Clin Onc. 10:1062-1068, 1992. - French Society of Pediatric Oncology (SFOP)

prospective randomized trial

238 pt < 18 yr old with HD treated with chemo + RT between 1982-88

staging lap in 2%

randomization: clinical stage IA or IIA: (1) ABVD x 4

(2) MOPP x 2 + ABVD x 2

RT: started 1 mo after chemo

field = involved field

dose = (CR or good PR) 2000 cGy

(< good PR) 4000 cGy

clinical stage IB, IIB, III-IV: all pt got MOPP x 3 + ABVD x 3

RT: (IB or IIB) field1 = involved field

dose1 = see above

field2 = prophylactic paraaortic/splenic (after 2 wk break)

dose2 = 2000 cGy

(III-IV) field = involved field (excluding extralymphatic sites)

dose = see above

"good chemo response" (95%): CR = complete clinical &/or radiologic disappearance of dz OR

good PR = > 70% reduction in tumor size

"poor chemo response" = < 70% reduction in tumor size or early recurrence before starting RT

| |stage IA-IIA |stage IB-IIB-III |stage IV |

|CR rate |82% |63% |38% |

|PR (> 70%) rate |15.5% |34% |33% |

|good chemo response rate |97.5% |97% |71% |

median f/u = 6 yr

| |stage I-II |stage III |stage IV |"good responders" |"poor responders" |

| |(n=177) |(n=40) |(n=21) |(n=227) |(n=11) |

|6-yr actuarial DFS rate |89% |82% |62% |89% |18% |

no difference in the ABVD vs MOPP/ABVD arms

recommendations = (1) stage IA-IIA "responders" - ABVD x 4 + involved field RT to 20 Gy

(2) stage IB-IIB "responders" - MOPP x 3 / ABVD x 3 + involved field & paraaortic/splenic RT to 20 Gy

(3) BMT for "poor responders"

S Donaldson, et al. J Clin Onc. 8:1128-1137, 1990.

retrospective study

pediatric early-stage HD

compared results from Stanford (pathologic staging, EF RT or chemo/IF RT) with St Bartholomew’s (clinical staging, IF RT)

higher relapse rate for IF RT alone, but equivalent overall survival b/c salvage chemo

| |pathologic staging |clinical staging |p-value |

| |EF RT or chemo + IF RT |IF RT | |

|10-yr RFS rate | | | |

| - large mediastinal mass | |53% | |

| - small bulk disease | |86% | |

|10-yr OS rate |91% |91% | |

D Jenkin, et al. Med Pediatr Onc. 18:265-272, 1990. - University of Toronto

G Schellong, et al. Ann Onc. 7:567-572, 1996. - German

G Schellong, et al. J Clin Onc. 17:3736, 1999. – German-Australian Pediatric HD Study Group DAL-HD-90 Trial

Lymphoma Articles\HD\Ped HD 90 German JCO 1999.pdf

578 pt

chemo: OPPA (OEPA) / COPP

replaced etoposide for procarbazine in boys to preserve fertility

RT: field1 = IFRT95

dose1 = 25 Gy (20 Gy in high risk arm)

field2 = CD to residual dz

dose2 = 30-35 Gy total

low risk: CS I, IIA

OPPA (OEPA) x 2

intermediate risk: CS IIB, IIIA

OPPA (OEPA) x 2 + COPP x 2

high risk: CS IIIB, IV

OPPA (OEPA) x 2 + COPP x 4

no difference between OPPA and OEPA

5-yr EFS rate = 91%

5-yr OS rate = 98%

| |5 yr DFS |

|Low Risk |95% |

|Int Risk |93% |

|High risk |87% |

U Ruhl, et al. Proc of ASTRO. 48:178-179, 2000 (abstr #133). – GPOH-HD 95 trial, Germany

update in U Ruhl, et al. IJROBP. 51:1209-1218, 2001.

Lymphoma Articles\HD\German HD 95 IJROBP 2001.pdf

prospective trial

830 pt with HD treated between 1995-2000

gallium scans & PET scans were not routinely used for staging

initial therapy: low risk group, TG 1: CS I, IIA ( OPPA or OEPA x 2 cycles

intermediate risk group, TG 2: CS IIAE, IIB, IIIA ( OPPA or OEPA x 2 cycles + COPP x 2 cycles

high risk group, TG 3: CS IIBE, IIIAE, IIIB, IV ( OPPA or OEPA x 2 cycles + COPP x 4 cycles

additional therapy based on re-staging studies: if cCR, then no further therapy (23% of pt)

if good cPR (> 75% reduction), then 20 Gy IFRT (62% of pt)

if cPR with < 75% reduction, then 30 Gy IFRT

(any residual mass > 50 cc in volume received a boost to 35 Gy)

treatment: OEPA x 2-6 cycles

if CR (22%) ( no RT

if PR with > 75% tumor regression (61%) ( IF RT to 20 Gy

if PR with 50-75% tumor regression (12%) ( IF RT to 30 Gy

chemo: OPPA (girls) or OEPA (boys) q28d

Vincristine 1.5 mg/m2 IV on d 1, 8, 15

Procarbazine 100 mg/m2 PO on d 1-15 or Etoposide 125 mg/m2 IV on d 3-6

Prednisone 60 mg/m2 PO on d 1-15

Adriamycin 40 mg/m2 IV on d 1, 15

COPP q28d

Cytoxan 500 mg/m2 IV on d 1, 8

Vincristine 1.5 mg/m2 IV on d 1, 8

Procarbazine 100 mg/m2 PO on d 1-15

Prednisone 40 mg/m2 PO on d 1-15

median f/u = 38 mo

| | |overall |CS I, IIA |CS IIAE, IIB, IIIA |CS IIBE, IIIAE, IIIB, IV |

|5-yr EFS rate |overall |90% |94% |91% |84% |

| |RT |93% |97% |92% |

| |No RT |89% |92% |81% |

| | |p=0.09 |p=NS |p=0.01 |

|relapse rate |RT |6% | | | |

| |No RT |9% | | | |

|5-yr OS rate |overall |97% | | | |

100% of failure in those with no RT did fail in the initial site (as at least part of the failure), where as those with RT only

failed in the IF in 25%.

• German Studies tried different regimens

OPPA/COPP- Vincristine, procarbazine, prednisone and doxorubicin/cyclophosphamide, vincristine, procarbazie and pred

- This regimen had good DFS

Then the German group tried to eliminate procarbazine but had poorer disease free survival rates

VP-16 used next (OEPA) and had a good DFS with this regimen

Therefore, other groups tried to use etoposide in advanced disease but did not have a good outcome

- Felt that VP-16 May be used in early stage disease but not advanced disease

S Donaldson @ ASTRO 2001 - Tri-Center Protocols (Stanford, St. Jude, Dana-Farber)

1990-98

96 pt with clinical stage I-II non-bulky, age < 18 yr

VAMP x 2 ( IFRT ( VAMP x 2

chemo: velban, adriamycin, MTX, prednisone

RT: field = IFRT

dose = 15 Gy (CR) or 25 Gy (< CR)

4-yr EFS rate = 94%

4-yr OS rate = 99%

V Vecchi, et al. Cancer. 72:2049-2057, 1993. - Italian (AIEOP) Multicenter Study

prospective trial

215 pt < 15 yr old with HD treated between 1983-89

Group 1: stage IA-IIA (non-bulky)

ABVD x 3 cycles ( RT

RT: field =

dose = 20-25 Gy

Group 2: stage IA (bulky), IB, IIA (bulky), IIB, IIIA

alternating MOPP/ABVD x 6 cycles ( RT

Group 3: stage IIIB, IVA, IVB

alternating MOPP/ABVD x 6 cycles ( RT ( MOPP/ABVD x 4 cycles

re-staging performed after 2 cycles chemo, before RT, 1 mo after RT (group 1-2), before maintenance chemo (group 3)

| |stage IA-IIA (non-bulky) |stage IA-IIA (bulky), IB, IIB, IIIA |stage IIIB, IVA, IVB |

|7-yr DFS rate |95% | | |

|7-yr OS rate | | | |

Nachman, et al. – CCG 5942 Rand trial of IFRT vs no RT for HD with CR to chemo. JCO 20: 3765-3771 2002.

Lymphoma Articles\HD\Peds HD Rand trial of CR to RT vs no RT.pdf

closed early due to excessive failures in chemo alone arm. Open from ’95 to ’98

829 pts with Pediatric HD (/=4 LN regions, Mediastinal dz > 1/3 thorax, >10 cm peripheral mass

Group 1 pts: Stage I without adverse features and IIA without adverse features

Group 2 pts: Stage I with adverse features and Stage II with adverse features or B symptoms, and Stage III pts

Group 3 pts: IV pts

chemo: Group 1--stage I, IIA non-bulky, < 4 sites, no hilar dz (alternating 2 COPP & 2 ABV)

Group II--stage I, IIA bulky or IIB-III (alternating 3 COPP & 3 ABV)

Group III--stage IV (Ara-C/VP-16, COPP/ABV, CHOP x 2)

if CR, randomized to (1) IF RT – 2100 cGy in 175 cGy fx

(2) no RT

if PR, then IF RT to 3500 cGy in 175 cGy fx

Note if IV disease with pulmonary involvement, pts received 10.5 Gy to lungs in 12 fractions

if < PR, then off study

CR- If incomplete radiologic response in mediastinum, could still have CR if >70% reduction and gallium – if prev +

PR- defined as 50-70% reduction in TV

Overall 650 pts had CR and eligible for randomization. Only 501 pts were randomized, most off protocol were observed

| |COPP/ABV x 4 (n=245) |COPP/ABV x 4 + IF RT (n=249) |p-value |Group 1 |Group 2 |Group 3 |

|3-yr EFS rate (for |87% |92% |0.57 |95% |82% |83% |

|CR) | | | | | | |

|3 yr EFS as treated |85% |93% |.0024 | | | |

|3-yr OS rate |98% |99% |NS | | | |

Median time to relapse for chemotherapy with observation was 6 months, and most 29/34 were in sites of known disease. Median time for relapse in IFRT was 14 mo with 7/12 occurred within in field only. Post relapse survival was better for rand pts who relapsed after chemo alone compared with those who relapsed after combined therapy (94% vs 84%). This improvement in EFS was seen in all stages treated. In addition, when analyzed by treatment actually received, those with RT did even better. Therefore, combination treatment has remained the standard of care

POG 8625

prospective randomized trial

stage I-II

4 cycles of chemo (2 MOPP & 2 ABVD)

if CR, randomized to (1) 2 additional cycles of chemo (1 MOPP + 1 ABVD)

(2) IF RT

| |MOPP/ABVD x 6 |MOPP/ABVD x 4 + IF RT |p-value |

|5-yr OS rate |97% |86% | |

|5-yr EFS rate |97% |86% | |

|5-yr DFS rate |86% |89% | |

no fatal toxicities and no 2nd malignancies to date

POG 9426

on-going trial

eligibility criteria: CS or PS IA, IIA, & PS IIIAmiro (dz limited to spleen, splenic, celiac, or portal nodes), age < 21yr

exclusion criteria: B-symptoms, bulky mediastinal dz, extranodal dz

staging w/u: CxR, CT chest/abd/pelvis, Gallium scan, ESR, BM biopsy, biochem panel

+/- staging LAP

repeat initially (+)scans after 2nd and 4th cycle of chemo & 8 wk after RT

DBVE x 2 cycles ( if CR, no further chemo ( IF RT

if PR (non-mediastinal dz), DBVE x 2 cycles ( if stable or further regression, then IF RT

if progression & biopsy(+), then off study

if NR or PD (non-mediastinal dz), off study

if PR (> 50% reduction of mediastinal dz) & (-)Ga67 scan ( IF RT

if < PR (< 50% reduction of mediastinal dz) regardless of Ga67 scan, DBVE x 2 cycles (

if CR or further dz regression & (-)Ga67 scan, then IF RT

if dz progression or (+)Ga67 scan, then biopsy ( if (+), then off study

randomization: (1) Zinecar – topoisomerase II inhibitor

(2) no Zinecar

DBVE: q28d cycle

Doxorubicin 25 mg/m2/day IVP on d 1 & 15

Bleomycin 10 IU/m2/day IVP on d 1 & 15

Vincristine 1.5 mg/m2/day IVP (max 2 mg) on d 1 & 15

Etoposide 100 mg/m2/day IVPB on d 1-5

RT: start 28-40 days after beginning the last cycle of chemo

field = involved nodal sites + 2 cm around any residual dz in the mediastinum

1) to ensure a 2 cm margin on neck dz, a spine block may not be appropriate

2) some bulky axillary or SC/IC dz may overlie humeral head or medial clavicle & could be missed with standard axillary field

dose = 2550 cGy in 150 cGy x 17 fx

unilateral neck: superior = lower border of mandible, tips of the mastoid, mid tragus

inferior = below clavicle, 2 cm on original disease if lower neck involved

medial = cover medial head of SCM & clavicular head, exclude vertebral body if possible, if not possible to

exclude ipsilateral epiphysis of cervical vertebrae include both to assure symmetric neck growth

lateral = medial 2/3 of clavicle, 2 cm on disease

bilateral neck: see above for superior, inferior, and lateral borders

may treat bilateral neck for unilateral involvement to assure symmetric neck growth

when used with a mediastinal field, use a 2 cm wide C-spine block

axilla: superior = inferior edge of clavicle

medial = 1 cm margin on lateral surface of thoracic cage

lateral = 2 cm on disease

inferior = 2 cm on disease, at least as low as the bottom of the 4th rib

shield humeral head

unilateral neck + contralateral axilla: _____________

unilateral neck + ipsilateral axilla: connect unilateral neck field to unilateral axilla field

mediastinum: superior = ______________

inferior = if no subcarinal or pericardial nodes, then dome of diaphragm (T10/11)

if subcarinal, pericardial, or diaphragmatic nodes, then ____________

lateral = 2 cm margin on residual disease

1-2 cm margin on hilum

1.5 cm margin on vertebral bodies to include internal mammary and paraspinous nodes

mediastinum + neck: connect neck and mediastinum fields

2 cm wide posterior C-spine block

mediastinum + neck + axilla: connect neck, mediastinum, & axilla fields (mantle)

spleen: superior = 1 cm margin of lung above dome of diaphragm

inferior = 2 cm margin on spleen on CT

medial = 2 cm margin on spleen, 2 cm margin on contralateral side of vertebral bodies to include upper PA nodes

lateral = cover rib cage

femoral or inguinal: AP field prescribed at depth of femoral nodes on CT (8-12 MeV e-)

superior = 3 cm above palpable nodes and parallel to inguinal fold

inferior = 3 cm below palpable nodes, 1-2 cm on femoral triangle _________

medial = 1-2 cm on femoral triangle _____________

lateral = _____________

iliac + inguinofemoral: AP/PA thru pelvis portion

AP photon with e- boost for groin portion

superior = L5/S1

inferior = ___________

medial = ___________

lateral = ____________

inverted Y field: superior = dome of diaphragm

inferior =

lateral = transverse processes of vertebrae, 2 cm around nodes, 2 cm on spleen/splenic pedicle

remainder like iliac + inguinofemoral field

para-aortic nodes + splenic pedicle: for rare situation of isolated PA nodal involvement

superior = dome of diaphragm in an interspace

inferior = L4/5

lateral = transverse processes, 2 cm on residual dz, 1-2 cm on clips at splenic pedicle

supra + infra-diaphragmatic dz: 4 wk rest between fields

gap between fields or use an extended field

f/u protocol: TSH, T4 q1yr x 10 if chest RT

FSH, LH (if pubertal) q1yr x 10

CxR q6mo x yr 1-5 ( q1yr x yr 5-10

CT scan q6mo x yr 1 ( q1yr x yr 2-5

PFTs q1yr x 5

ECG/Echo q3yr

mammograms if chest RT

POG 9425

DBVE-PC x 3 cycles ( 25 Gy IFRT

2 more cycles ( 25 Gy IFRT

pt divided based on early rapid response

Stage IB-IIB or Bulky dz – current standard per ASTRO 2001 refresher course is combined modality therapy

( ABVD x 6 cycles

RT: field = involved field

dose = 2100 cGy

would follow CCG 5942

Link, et al. Proc of ASCO 1994. –

CS I-II bulky or CS III-IV

VEPA x 6 + IF RT (15-25 Gy)

chemo: velban, etoposide, prednisone, adriamycin

5-yr EFS rate = 68%

5-yr OS rate = 81%

closed early due to poor outcome

S Donaldson @ ASTRO 2001 - Tri-Center Protocols (Stanford, St. Jude, Dana-Farber)

1994-98

122 pt with CS I-II bulky or CS III-IV

VAMP/COPP x 2 ( IFRT ( VAMP x 2

chemo: velban, adriamycin, MTX, prednisone

cytoxan, vincristine, procarbazine, prednisone

RT: field = IFRT

dose = 15 Gy (CR) or 25 Gy (< CR)

| |2-yr EFS rate |

|CS I-II bulky |90% |

|CS III-IV |81% |

Stage III-IV – current standard per ASTRO 2001 refresher course is combined modality therapy

( ABVD x 6 cycles

OR

COPP/ABV X 6 total (3 of each)

RT: field = involved field

dose = 20 – 21 Gy

field = residual disease after PR

dose = 1000 cGy (total = 3500 cGy)

( MOPP/ABVD x 8 cycles without RT

controversial for children

do not recommend

R Hutchinson, et al. Med Pediatr Onc. 21:61, 1993. (abstract) - CCG 521

update in R Hutchinson, et al. J of Clin Onc. 16:897, 1998.

prospective randomized trial

111 pt with stage III-IV

randomization: (1) alternating ABVD x 6 / MOPP x 6

(2) ABVD x 6 + IF RT

RT: field = involved field

dose = 2100 cGy

| |ABVD x 6 / MOPP x 6 |ABVD x 6 + RT |p-value |

|4-yr OS rate |84% |90% |NS |

|4-yr EFS rate |77% |87% |NS |

criticisms = not enough patients to show a difference

M Weiner, et al. J Clin Onc. 15:2769-2779, 1997. - POG 8725

prospective randomized trial

179 children with stage IIB, IIIA2, IIIB, & IV Hodgkin's Dz treated between 1987-92

staging lap in 36%

randomization: (1) alternating MOPP x 4 /ABVD x 4 cycles (n=89)

(2) alternating MOPP x 4 /ABVD x 4 cycles + EF RT (n=90)

RT: if no subdiaphragmatic dz ( STNI (mantle + paraaortic/spleen)

if subdiaphragmatic dz( TNI (mantle + paraaortic/spleen + pelvis)

dose = 2100 cGy in 150 cGy fx to nodes and spleen

1050 cGy in 150 cGy fx to nonlymphoid organs (liver, lung, pericardium, kidney, etc)

2 wk rest between fields

re-staging performed after 3, 6, & 8 cycles of chemo and after RT

if < CR after chemo ( biopsy suspicious site ( if confirmed residual dz, off protocol

90% CR rate after 8 cycles of MOPP/ABVD

10 of 80 RT patients did not receive it

| | |MOPP/ABVD x 8 (n=89) |MOPP/ABVD x 8 + RT (n=90) |p-value |

|5-yr actuarial OS rate | |96% |87% |NS |

|5-yr actuarial EFS rate |overall |79% |80% |NS |

| |CR after chemo (n=161) |82% |87% |NS |

if clinical CR after 3 cycles chemo, 5-yr EFS rate = 94%

if not clinical CR after 3 cycles chemo, 5-yr EFS rate = 78%

conclusions = (1) in children with stage clinical stage IIB-IV HD, 8 cycles of alternating MOPP/ABVD produces equivalent

outcome compared to chemo + RT

(2) clinical response after 3 cycles of chemo if a powerful predictor of outcome

Found no difference in 5 year EFS when analyzed by intent to treat, the 5 yr EFS of 80% was inferior to that of other trial

and when analyzed by treatment actually received, there was a benefit for radiation. Therefore, POG continued with RT

CCG-59704

eligibility criteria: stage II-III + bulky disease or B-symptoms, stage IV

BEACOPP x 2 ( re-evaluate ( BEACOPP x 2 ( re-evaluate (

if CR/PR-1(> 70% ( size & (-)Ga67 scan) ( if male, then ABVD x 2 + IF RT

if female, then COPP/ABV x 4

if PR-2(50-70% ( size) ( BEACOPP x 4 + IF RT

if PD, then off protocol

BEACOPP: Bleomycin

Etoposide

Adriamycin

Cytoxan

Vincristine

Procarbazine

Prednisone

Link, et al. Proc of ASCO 1994. –

CS I-II bulky or CS III-IV

VEPA x 6 + IF RT (15-25 Gy)

chemo: velban, etoposide, prednisone, adriamycin

5-yr EFS rate = 68%

5-yr OS rate = 81%

closed early due to poor outcome

S Donaldson @ ASTRO 2001 - Tri-Center Protocols (Stanford, St. Jude, Dana-Farber)

1994-98

122 pt with CS I-II bulky or CS III-IV

VAMP/COPP x 2 ( IFRT ( VAMP x 2

chemo: velban, adriamycin, MTX, prednisone

cytoxan, vincristine, procarbazine, prednisone

RT: field = IFRT

dose = 15 Gy (CR) or 25 Gy (< CR)

| |2-yr EFS rate |

|CS I-II bulky |90% |

|CS III-IV |81% |

G Schellong, et al. Baillieres Clin Haematol. 9:619-634, 1996. - German

P Mauch, et al. Cancer. 51:925-932, 1988. - Joint Center

Refractory/Relapsed Disease

• Divided into 3 groups

o Primary refractory disease

o Early relapse 1 year since remission

( relapse typically occurs within 4 yr

( prognostic factors:

site of relapse (nodal better than extranodal)

stage assigned to relapse (early better than advanced)

histology (LP & NS better than MC)

( things to consider when choosing appropriate salvage therapy:

did the pt ever achieve a CR or was the dz refractory to initial tx?

if a CR was achieved, was it durable (> 1 yr)?

was the relapse in nodal or extranodal sites?

was the stage at relapse early or advanced?

( Standard-Dose Chemotherapy

indications: initially treated with RT alone

DFS rate = 55-80%

Involved-Field RT

considered for areas of bulky dz if can be given safely

• Relapse at supradiaphragmatic nodal site alone without B symptoms may be able to be salvaged with RT alone

( High-Dose Chemotherapy + Stem-Cell Rescue

indications: initially treated with chemo

| |standard dose chemo |high dose chemo + BMT |

|DFS rate |10-50% | |

Involved-Field RT

considered for areas of bulky dz if can be given safely

( Palliative Therapy

J Yahalom, et al. Sem Radiat Oncol. 6:210-224, 1996. –

D Linch, et al. Lancet. 341:1051-1054, 1993. – BNLIG

prospective randomized trial

40 pts with recurrent HD

Study closed early due to better DFS with BMT arm

Randomized to

1. Standard-dose BEAM )mini beam

2. High dose BEAM with autologous BMT

DFS favored BMT with DFS of 53% for those with BMT vs 10% for those without BMT

A Yuen, et al. Blood. 89:814-822, 1997. – Stanford University

matched pair analysis

| |conventional dose chemo |high dose chemo + BMT |p-value |

|EFS rate |27% |53% | |

J Poen, R Hoppe, et al. IJROBP. 36:3-12, 1996. – Stanford University

retrospective study

pt with stage I-III HD at relapse

| |autologous BMT |autologous BMT + IFRT |p-value |

|3-yr RFS rate |67% |100% | |

|3-yr OS rate |60% |85% | |

Hodgkin’s Disease Diagnosed During Pregnancy

1st Trimester of Pregnancy

( Therapeutic Abortion

( Close Observation & Induce Delivery at 32-36 wk after Fetus Reaches Lung Maturity (by amniocentesis)

considered if stage I-IIA supradiaphragmatic and growing slowly

( Mantle Field RT

most of dose to fetus is via internal scatter

techniques to ( dose to fetus: raise lower border of field to T8/9

HBB lower border of field

lead shield over abdomen

Delivery by C-section after Fetus Reaches Lung Maturity and Simultaneous Staging Lap

if (-)lap, then PA RT

if (+)lap, then ABVD x 6

SY Woo, et al. IJROBP. 23:407-412, 1992. – MD Anderson

16 pt

mantle field with abdominal shielding

no congenital abnormalities

( Chemotherapy

not recommended during 1st trimester

1/3 of infants develop congenital abnormalities

Thomas, et al. Cancer. 38:1443-1451, 1976. –

2nd Half of Pregnancy

( Close Observation & Induce Delivery at 32-36 wk after Fetus Reaches Lung Maturity (by amniocentesis)

appropriate for most pt unless symptomatic advanced disease

C Jabobs, S Donaldson, et al. Annals of Int Med. 95:669-675, 1981. –

Nisce, et al. Am J Clin Onc. 9:146-151, 1986. –

( Vinblastine + Prednisone

used for symptomatic pt with advanced stage or rapidly progressing disease

vinblastine has never been associated with fetal abnormalities in the 2nd half of pregnancy

prednisone has an antitumor effect and hastens fetal pulmonary maturity

Follow-up

NCCN Guidelines:

( H&P – finds 70% of all the relapses

Note: Reactive hyperplasia of LN can occur in those just outside the prior RT port.

blood work (CBC, Plt, Lytes, LFTs, LDH, ESR)

q3mo x yr 1-2 ( q4mo x yr 3-4 ( q6mo x yr 5 ( q1yr

( TSH, T4

if neck RT given

q6mo

( CxR – Finds 25% of relapses

q6mo x yr 1-3 ( q1yr

( CT chest/abd/pelvis

if CS I-II, q1yr x 5 yr

if CS III-IV, q6mo x yr 1-3 ( q1yr x yr 4-5

(consider PET scan as an alternative ??)

( screening mammograms

if mantle RT given

q1yr

start 8-10 yr after RT or age 40 yr, whichever is earliest

( re-vaccinate for H. flu & pneumovax q6yr if splenectomy or spleen RT ??

Complications

RT Toxicity:

( Acute Side Effects:

Mantle Field

- occipital hair loss / epilation ( starts to regrow at 3 mo

- mild skin reaction in neck, shoulders, and axilla

- oral mucositis

- esophagitis

- thickening of saliva

- altered sense of taste

- fatigue

- nausea and occasional vomiting

- mild myelosuppression (50%)

Paraaortic Field

- nausea and vomiting

- fatigue

- mild myelosuppression (75%)

- transient ( liver enzymes (alk phos)

( Subacute Toxicity:

- Lhermitte Sign

- 10-15% incidence after mantle irradiation

- transient myelopathy with paresthesias down the dorsal portion of the extremities with neck flexion

- insidious onset 1-2 mo after RT and resolves over 2-6 mo

- caused by transient demyelination

- Temporary Xerostomia

- occurs after mantle irradiation & saliva returns to normal within 6 mo

- may be permanent after Waldeyer irradiation

- intensive fluoride treatment to minimize incidence of dental caries

- Radiation Pneumonitis

- 1-6 mo after completion with mild nonproductive cough, low-grade fever, & dyspnea on exertion

- may occur earlier with prior chemotherapy

- dose threshold =

- symptomatic incidence = 5% (2-3x ('d risk if large mediastinal LAD or MOPP chemo)

- treatment = NSAIDS

corticosteroids x 4-6 wk with slow taper

N Tarbell, et al. IJROBP. 18:275-281, 1990. - Joint Center

retrospective study

590 pt with stage IA-IIIB supradiaphragmatic HD received mantle field RT between 1969-84

RT doses: 3600-4000 cGy to uninvolved areas

4000-4400 cGy to involved areas

25% received MOPP chemo

median f/u = 104 mo

| | |symptomatic radiation pneumonitis rate |

|overall | |6% |

|small or no mediastinal dz | |4% |

|bulky mediastinal dz | |14% |

|RT alone |overall |3% |

| |whole lung to 1500 cGy |13% |

|chemo + RT |overall |11% |

| |whole lung to 1500 cGy |15% |

Hancock, et al. Semin Radiat Oncol. 6:225, 1996. –

- Acute Pericarditis

- 2-3% risk

- fever, chest pain, friction rub, pericardial effusion

- treatment = NSAIDS

- resolves over several weeks

- Acute Myocarditis

( Late Complications:

- Hypothyroidism

- 30% incidence after mantle irradiation

- subclinical with elevated TSH and normal T4

- treatment = L-thyroxine

N Tarbell, et al. IJROBP. 18:275-281, 1990. - Joint Center

retrospective study

590 pt with stage IA-IIIB supradiaphragmatic HD received mantle field RT between 1969-84

RT doses: 3600-4000 cGy to uninvolved areas

4000-4400 cGy to involved areas

25% received MOPP chemo

median f/u = 104 mo

| |overall |age < 16 yr |age > 16 yr |

|chemical hypothyroidism |25% |64% |29% |

|clinical hypothyroidism |3% (2(/2 early tx) | | |

|median time to onset |44 mo | | |

Sklar, et al. J Clin Endocrinol Metab. 85:4441, 2000. –

- Herpes Zoster

- occurs up to 1-2 yr after treatment in 10-15%

- treatment = acyclovir

- Cardiac Toxicity

- arrhythmias

- MI RR ~ 2.5

- CAD

- Second Primary Cancers

- RR 6.4

- 10-15% at 15 yr

- AML – 5% after MOPP x 4 (10% after 6 cycles)

seen after chemotherapy (alkylating agents or procarbazine) latent period of 3-7 yr

- lymphoma – diffuse large cell lymphoma after latent period of > 5 yr

- solid tumors – 8% @ 15-yr

after radiation therapy with latent period of 10-15 yr

breast > lung, GI tract cancers

- In a Stanford series one of the highest risks for 2nd malignancy was need for salvage therapy.

A Ng, et al. Proc of ASTRO. 51:67-68, 2001. – Harvard

Blood et al. 2002

retrospective study

1319 pts with stage IA-IVB Hodgkin’s dz treated between 1969-97

Included only 961 pts with > 10 yr f/u

66% had mantle and paraaortic with total dose near 40 Gy and median of 36 Gy

85% had chemo with 296 as MOPP

median f/u = 12 yr

181 2nd malignancies occurred (excluding epidermal skin ca)

3 most common solid tumors = breast, lung, GI tract

less common solid tumors = sarcoma, H&N, thyroid, melanoma

| |15 yr risk |20 yr risk |

|Risk of 2nd Malignancy |14% |23% |

|2nd malignancy type |median latent period |age at dx |RR breast cancer |yr from tx |RR of 2nd ca |

|Leukemia |4.8 yr |< 15 yr |111 |0-5 yr |2 |

|NHL |7.3 yr |15-19 yr |31 |5-10 yr |3 |

|solid tumor |12.7 yr |20-25 yr |16 |10-15 yr |4 |

| | |26-29 yr |8 |15-20 yr |7 |

| | |30-35 yr* |4 |> 20 yr |11 |

*no ( risk of breast ca if diagnosed after age 35 yr

no difference in 2nd malignancy risk between males and females

RR of 2nd malignancy was lower after RT alone vs chemo + RT (4 vs 6) aka higher rate of 2nd malig with combo Rx

Decreased risk of 2nd malignancy with decreasing field size

Risk of Breast cancer significantly increased with dx prior to age 30 vs not significant if after 35 yo

In 1st 10 yrs 50% are solid tumors and 2nd 10 yrs 85% are solid tumors

Overall 4.6 fold increase risk of 2nd cancer relative to general population. Increased risk after 10-15 yrs is mainly driven by

solid tumors, mostly breast

- Infertility

- for pelvic irradiation (ovaries overlie the iliac lymph nodes)

- 100% sterility and amenorrhea for doses of 30-35 Gy

- oophoropexy moves ovaries into midline low pelvis behind uterus to allow for shielding (keep dose < 4 Gy)

- Small Bowel Obstruction

- 1% after < 35 Gy

- Special Pediatric Issues

- Infertility

- 2nd Malignancy:

~ 15% risk at 10 yr

| |leukemia (2(/2 alkylating agent) |solid tumor* (2(/2 RT) |overall |

|5-yr rate |1% |0.4% |2% |

|10-yr rate |3% |2% |5% |

|15-yr rate |4% |6% |9% |

|median time delay |5 yr |12 yr | |

* basal cell ca, breast ca, thyroid ca, sarcoma

Bhatia, et al. NEJM. 334:12, 1996. – Late Effects Study Group (multi-institutional study)

1,380 pt

median f/u = 11.4 yr

L Constine, et al. Proc of ASTRO. 51:70, 2001. – multi-institutional

retrospective study

928 pt < 18 yr old treated for HD between 1960-90

median f/u = 14.5 yr

RR of 2nd malignancy = 17 (greater for females)

median latent period for breast ca = 15.3 yr

only 2 developed breast ca after doses < 25 Gy

Tucker, et al. NEJM. 318:76, 1988. – Stanford

15-yr risk: all cancers 18%

solid tumors 13%

leukemia 3%

lymphoma 2%

Wolden, et al. J Clin Onc. 16:536, 1998. – Stanford

694 pt < 21 yr old

tx: RT alone 46%

chemo + RT 51%

chemo alone 3%

mean RT dose = 38 Gy

mean f/u = 13 yr

56 pt developed a 2nd cancer: 27% breast, 22% sarcoma, 14% leukemia, 7% lung, 7% melanoma, 5% HNL,

5% thyroid, 5% salivary

- Bone and Soft Tissue Growth Impairment / Hypoplasia

short siting height, small neck circumference, shortened clavicles, small thorax

most significant in age < 13 yr & dose > 35 Gy

dose < 25 Gy results in no significant height abnormalities

Willman, et al. IJROBP. 28:85, 1994. –

SS Donaldson, et al. Pediatr Clin North Am. 38:457-473, 1991. - Stanford University

RJ Carmel, et al. Cancer. 37:2813-2725, 1976. -

SL Hancock, et al. NEJM. 325:599-605, 1991. -

M Henry-Amar, et al. Ann Oncol. 3:S117-128, 1992. –

FE Van Leeuwen, et al. J Clin Onc. 18:487-497, 2000. –

S Ghatia, et al. NEJM. 334:745-751, 1996. –

Chemotherapy Toxicity

( Acute Toxicity:

- alopecia

- nausea & vomiting

- diarrhea

- mucositis

- neuropathy -- paresthesias and weakness

- confusion

- myelosuppression

- procarbazine ( disulfiram reaction

( Chronic Toxicity:

- hypothyroidism

- pulmonary fibrosis

- MOPP ( 5% risk of AML at 10 yr

maximum risk at 5-9 yr

possibly increased with age > 40 yr or splenectomy

risk depends on the # of cycles given

male infertility (80%)

female infertility (50%)

25% for age < 25 yr

90% for age > 25 yr

- ABVD ( < 1% risk of AML at 10 yr

male infertility (20%)

female infertility (50%)

25% for age < 25 yr

90% for age > 25 yr

bleomycin lung toxicity (5%)

cardiomyopathy

Splenectomy Toxicity

( Bacterial Sepsis (3%)

all patients should be immunized for H. influenza b, Meningococcus, & S. pneumoniae at least 1 wk prior to therapy

re-immunization 2 yr after therapy & q6yr thereafter

( Leukemia

possibly slightly increased risk

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