TABLE OF CONTENTS - Cancer Treatment & Cancer …
Breast Cancer ? Invasive1 Stage I-III2
Page 1 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
TABLE OF CONTENTS
Initial Evaluation...................................................................................................................................................... Page 2 Hormone receptor-positive/HER2-negative....................................................................................................................... Pages 3-4 Hormone receptor-positive/HER2-positive or Hormone receptor-negative/HER2-positive............................................................. Page 5 Hormone receptor-negative/HER2-negative (triple negative breast cancer)................................................................................Page 6 Evaluation During and Post Neoadjuvant Treatment...........................................................................................................Page 7 Radiation Therapy....................................................................................................................................................... Page 8 Surveillance............................................................................................................................................................... Page 9 Evaluation for Local Recurrence.....................................................................................................................................Page 10 Appendix A: Gene Expression Considerations for Determination of Prognosis and Need for Adjuvant Chemotherapy in Patients
with Hormone receptor-positive/HER2-negative Breast Cancer.............................................................................. Page 11 Appendix B: Chemotherapy and Targeted Therapy Options for Neoadjuvant/Adjuvant Systemic Therapy...................................... Pages 12-13 Appendix C: Endocrine Neoadjuvant/Adjuvant Therapy Options............................................................................................ Page 14 Appendix D: Criteria for Omitting Axillary Node Dissection................................................................................................... Page 15 Appendix E: Selection of Patients for Radiation to Regional Lymphatics...................................................................................Page 15 Principles of Breast Oncologic Surgery.............................................................................................................................. Pages 16-19 Suggested Readings...............................................................................................................................................................................Pages 20-25 Development Credits.............................................................................................................................................................................Pages 26-27
1 There are special circumstances in which these guidelines do not apply. These include, but are not limited to:
Sarcoma of the breast
Patients with lupus and scleroderma
Cancer during pregnancy
Lymphoma of the breast
Patients with limited life expectancy
Special histologies (e.g., tubular, medullary, pure papillary, or colloid)
2 For inflammatory breast cancer, see Breast Cancer - Inflammatory (IBC) algorithm
Copyright 2023 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V17 Approved by Executive Committee of the Medical Staff on 06/20/2023
Breast Cancer ? Invasive Stage I-III
Page 2 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
Note: Consider Clinical Trials as treatment options for eligible patients.
INITIAL MULTIDISCIPLINARY CLINICAL STAGING EVALUATION
History and physical Pathology review1 Bilateral diagnostic mammography
and Ultrasound of breast(s) and regional
nodal basins with FNA or core biopsy Based on imaging and/or clinical
indications, MRI breast with and without contrast may be considered Clip placed in largest node with biopsy confirmed metastasis CBC with differential, liver function tests (total bilirubin, alkaline phosphatase, transaminases), creatinine Genetic testing and counseling as indicated2 Lifestyle risk assessment3
HER2 (human epidermal growth factor receptor) status
ER, PR status Histologic type Composite histologic grade Consider Ki-67 Clinical/imaging tumor size Lymph node status Body imaging as indicated4
HR-positive/ HER2-negative
HR-positive/ HER2-positive8
HR-negative/ HER2-positive8
TREATMENT
Favorable characteristics (grade I/II, strongly ER/PR
positive, low Ki-675)
For adverse features (large nodal burden, high Ki-677,
high grade)
Tumor < 1 cm and lymph nodes negative
Tumor 1 cm with any lymph node status or tumor of any size with nodal involvement
Tumor < 1 cm and lymph nodes negative
Tumor 1 cm with any lymph node status
Definitive breast and nodal surgery (see Page 3)
If unfavorable breast to tumor size ratio and patient desires BCT6, consider neoadjuvant endocrine therapy
Consider neoadjuvant chemotherapy (see Page 4)
Definitive surgery and sentinel lymph node biopsy (see Page 5)
Neoadjuvant systemic therapy (see Page 5)
Definitive surgery and sentinel lymph node biopsy (see Page 5)
Neoadjuvant anti-HER2 and chemotherapy (see Page 5)
BCT = breast conservation therapy ER = estrogen receptor
HR = hormone receptor PR = progesterone receptor
Tumor < 1 cm and
Definitive surgery and sentinel lymph
FNA = fine needle aspiration
HR-negative/
lymph nodes negative
node biopsy (see Page 6)
1 Review MD Anderson approved breast biomarkers 2 See Genetic Counseling algorithm 3 See Physical Activity, Nutrition, and Tobacco Cessation algorithms; ongoing reassessment
of lifestyle risks should be a part of routine clinical practice
HER2-negative (triple negative breast cancer)
Tumor 1 cm with any lymph node status
Neoadjuvant systemic therapy (see Page 6)
4 Patients with clinical stage IIB or higher, or signs or symptoms suggestive of metastatic disease should be considered for additional imaging
5 Low Ki-67 is defined as below institutional median value
6 High Ki-67 is defined as above institutional median value
7 Candidates for BCT: Tumor to breast size ratio allows for acceptable cosmetic result No evidence of diffuse calcifications on mammogram
8 HER2-positive by either immunohistochemistry 3+ or FISH, (HER2/CEP17 ratio 2 or HER2 copy number 6)
Department of Clinical Effectiveness V17
Copyright 2023 The University of Texas MD Anderson Cancer Center
Approved by Executive Committee of the Medical Staff on 06/20/2023
Breast Cancer ? Invasive Stage I-III
Page 3 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
Note: Consider Clinical Trials as treatment options for eligible patients.
SURGICAL CONSIDERATIONS1
BCT or total
TREATMENT
mastectomy with
Consider gene expression testing for risk stratification to guide chemotherapy5
Yes sentinel lymph node biopsy (SLNB) with
(see Appendix A for gene expression testing and indications for chemotherapy)
pN0
See Appendix B and Appendix C for treatment options, if indicated
Favorable characteristics
Candidate
or without reconstruction4
See Page 8 for radiation therapy
HR-positive/ HER2-negative
(grade I/II, strongly
ER/PR positive, low Ki-672)
and cN0
for BCT3 at presentation?
Total mastectomy with No SLNB with or without
reconstruction4
Favorable characteristics
(grade I/II, strongly ER/PR positive, low Ki-672)
and
cN1(1-3 abnormal level 1/II nodes on ultrasound)7,8,9
Candidate
Yes
for BCT3 at
presentation? No
No further axillary
Meets ACOSOG Z0011 Yes
surgery
pN1
or AMAROS or
Adjuvant chemotherapy (see Appendix B) followed by adjuvant endocrine
IBCSG 2301 criteria6?
No Level I/II axillary dissection
therapy (see Appendix C) See Page 8 for radiation
therapy
BCT
Consider gene expression
testing (see Appendix A) if
Level I/II axillary dissection10, 11
limited nodal disease and other favorable prognostic
Total mastectomy with or without reconstruction4
factors are present
ACOSOG = American College of Surgeon Oncology Group
For adverse features (large nodal burden, high Ki-67, high grade)
See Page 4
AMAROS = After Mapping of the Axilla: Radiotherapy Or Surgery BCT = breast conservation therapy ER = estrogen receptor
1 Patients with hereditary breast and ovarian cancer syndrome, deleterious BRCA1 and 2 mutations, history of chest wall
HR = hormone receptor
radiation therapy and > 20% lifetime risk of breast cancer should be considered for risk reducing mastectomy
IBCSG = International Breast Cancer Study Group
2 Low Ki-67 is defined as below institutional median value
PR = progesterone receptor
3 Candidates for BCT: Tumor to breast size ratio allows for acceptable cosmetic result No evidence of diffuse calcifications on mammogram SLND = sentinel lymph node dissection
4 For patients with stage II disease requiring post-mastectomy radiation, consider delayed reconstruction. For patients with stage III disease, delayed reconstruction is generally preferred. Pre-operative consultation with Plastic Surgery and
Radiation Oncology recommended. 5 Gene expression testing may not be indicated for post-surgery patients with all favorable prognostic factors present 6 See Appendix D 7 A positive lymph node identified on preoperative ultrasound should be clipped at the time of biopsy and every effort should be made to remove the clipped node at the time of surgery 8 Retrospective institutional data suggest that patients with ultrasound detected metastases, even if small volume, have a higher burden of nodal involvement than patients with SLND-detected metastases 9 Chemotherapy is not indicated in postmenopausal patients with 1-3 positive nodes and a gene expression recurrence score of 25. For premenopausal patients, chemotherapy is recommended in node positive patients regardless of the
recurrence score. The plan for surgical management of the axilla in the context of menopausal status and timing of systemic therapy should be discussed with the medical oncologist. 10 Level I/II dissection is the current standard of care for patients with cN1 disease undergoing up front surgery. 11 As delineated in recommendations by the National Comprehensive Cancer Network (NCCN), up front targeted axillary dissection can be considered in selected patients with multidisciplinary input. Please note these data are
not supported by level 1 evidence and this approach is an active area of investigation within our institution.
Department of Clinical Effectiveness V17
Copyright 2023 The University of Texas MD Anderson Cancer Center
Approved by Executive Committee of the Medical Staff on 06/20/2023
Breast Cancer ? Invasive Stage I-III
Page 4 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
Note: Consider Clinical Trials as treatment options for eligible patients.
SURGICAL CONSIDERATIONS1
TREATMENT
HR-positive/ HER2-negative
For adverse features (large nodal burden2, high Ki-673, high grade)
Neoadjuvant chemotherapy4 (see Appendix B) followed by definitive surgery5 and endocrine therapy (see Appendix C)
See Page 7 for evaluation during chemotherapy and definitive surgery recommendations
BCT = breast conservation therapy HR = hormone receptor
1 Patients with hereditary breast and ovarian cancer syndrome, deleterious BRCA1 and 2 mutations, history of chest wall radiation therapy and > 20% lifetime risk of breast cancer should be considered for risk reducing mastectomy 2 Large nodal burden is defined as clinical node positive disease with 4 level I/II suspicious lymph nodes on ultrasound 3 High Ki-67 is defined as above institutional median value 4 Consider neoadjuvant systemic therapy for patients with large tumors interested in BCT 5 Definitive surgery should be considered if contraindications to systemic therapy
Copyright 2023 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V17 Approved by Executive Committee of the Medical Staff on 06/20/2023
Breast Cancer ? Invasive Stage I-III
Page 5 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
Note: Consider Clinical Trials as treatment options for eligible patients.
SURGICAL CONSIDERATIONS1
TREATMENT BASED ON PATHOLOGIC FINDINGS
HR-positive/HER2-positive with tumor < 1 cm or
HR-negative/HER2-positive with tumor < 1 cm and cN0
Candidate Yes for BCT2 at
presentation? No
BCT or total mastectomy with sentinel lymph node biopsy (SLNB) with or without reconstruction3
Total mastectomy with SLNB with or without reconstruction3
pN0
No further
Adjuvant anti-HER2-
Meets ACOSOG Z0011
axillary surgery Yes
positive therapy (see Appendix B) and endocrine
pN1
or AMAROS or
therapy as indicated (see
IBCSG 2301
No
Appendix C)
criteria4?
Level I/II axillary
See Page 8 for radiation
dissection
therapy
HR-positive/HER2-positive with tumor 1 cm or tumor of any size with nodal involvement
or HR-negative/HER2-positive
with tumor 1 cm with any lymph node status
Neoadjuvant chemotherapy and anti-HER2 therapy (see Appendix B) followed by definitive surgery5
See Page 7 for evaluation during systemic therapy and
definitive surgery recommendations
Yes Residual disease?
No
T-DM1 (ado-trastuzumab emtansine) for 14 total doses and endocrine therapy as indicated (see Appendix C)
Anti-HER2 antibody therapy alone to complete one-year of therapy and endocrine therapy as indicated (see Appendix C)
ACOSOG = American College of Surgeon Oncology Group ALND = axillary lymph node dissection AMAROS = After Mapping of the Axilla: Radiotherapy Or Surgery BCT = breast conservation therapy HR = hormone receptor
1 Patients with hereditary breast and ovarian cancer syndrome, deleterious BRCA1 and 2 mutations, history of chest wall radiation therapy and > 20% lifetime risk of breast cancer should be considered for risk reducing mastectomy 2 Candidates for BCT: Tumor to breast size ratio allows for acceptable cosmetic result No evidence of diffuse calcifications on mammogram 3 For patients with stage II disease requiring post-mastectomy radiation, consider delayed reconstruction. For patients with stage III disease, delayed reconstruction is generally preferred. Pre-operative consultation with Plastic
Surgery and Radiation Oncology recommended. 4 See Appendix D 5 Definitive surgery should be considered if contraindications to systemic therapy
Department of Clinical Effectiveness V17
Copyright 2023 The University of Texas MD Anderson Cancer Center
Approved by Executive Committee of the Medical Staff on 06/20/2023
Breast Cancer ? Invasive Stage I-III
Page 6 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
Note: Consider Clinical Trials as treatment options for eligible patients.
SURGICAL CONSIDERATIONS1
TREATMENT BASED ON PATHOLOGIC FINDINGS
BCT or total
mastectomy with
sentinel lymph node
pN0
biopsy (SLNB) with
Tumor < 1 cm and cN0
Candidate for BCT2 at
Yes
or without reconstruction3
presentation?
HR-negative/ HER2-negative (triple negative breast cancer)
No
Total mastectomy
pN1
with SLNB with or
without
reconstruction3
Consider adjuvant chemotherapy (see Appendix B) See Page 8 for radiation therapy
Meets
Yes
ACOSOG Z0011
or AMAROS or
IBCSG 2301
criteria4?
No
No further axillary surgery
Level I/II axillary dissection
Adjuvant systemic therapy (see Appendix B)
See Page 8 for radiation therapy
Tumor 1 cm with any lymph node status
Neoadjuvant chemotherapy5 (see Appendix B) followed by definitive surgery6 See Page 7 for evaluation during chemotherapy and definitive surgery recommendations
ACOSOG = American College of Surgeon Oncology Group ALND = axillary lymph node dissection AMAROS = After Mapping of the Axilla: Radiotherapy Or Surgery BCT = breast conservation therapy HR = hormone receptor IBCSG = International Breast Cancer Study Group
1 Patients with hereditary breast and ovarian cancer syndrome, deleterious BRCA1 and 2 mutations, history of chest wall radiation therapy and > 20% lifetime risk of breast cancer should be considered for risk reducing mastectomy 2 Candidates for BCT: Tumor to breast size ratio allows for acceptable cosmetic result No evidence of diffuse calcifications on mammogram 3 For patients with stage II disease requiring post-mastectomy radiation, consider delayed reconstruction. For patients with stage III disease, delayed reconstruction is generally preferred. Pre-operative consultation with
Plastic Surgery and Radiation Oncology recommended. 4 See Appendix D 5 Add pembrolizumab for cT1cN1 or T2N0 or greater 6 Definitive surgery should be considered if contraindications to systemic therapy
Department of Clinical Effectiveness V17
Copyright 2023 The University of Texas MD Anderson Cancer Center
Approved by Executive Committee of the Medical Staff on 06/20/2023
Breast Cancer ? Invasive Stage I-III
Page 7 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
Note: Consider Clinical Trials as treatment options for eligible patients.
EVALUATION DURING AND POST NEOADJUVANT TREATMENT
SURGICAL OPTIONS
Patients receiving neoadjuvant
systemic therapy
Assess tumor size at least every 6 weeks and at completion of systemic treatment with physical exam
At completion of systemic treatment1: Ipsilateral diagnostic mammography and Ultrasound of breast(s) and/or MRI breast with and without contrast If clinically indicated, ultrasound of nodal basin(s)
At any point for clinical suspicion of disease progression, consider mid-treatment MRI breast with and without contrast2 (preferred) or ultrasound of breast and nodal basin(s) If clinical progression, consider change in systemic therapy or proceed with surgery if resectable
BCT = breast conservation therapy SLNB = sentinel lymph node biopsy
Yes
BCT candidate2?
No
Breast conserving surgery3: If clinically node negative at diagnosis, proceed with sentinel
node biopsy followed by axillary lymph node dissection if sentinel node is positive If clinically node positive, confirmed by needle biopsy proceed with axillary lymph node dissection or if axillary nodal disease limited at presentation4 and is no longer evident, consider SLNB with documented removal of clipped node and if no residual disease proceed to radiation therapy without axillary lymph node dissection
Total mastectomy with nodal treatment as determined by initial nodal status: If clinically node negative at diagnosis, proceed with sentinel
node biopsy followed by axillary lymph node dissection if sentinel node positive If clinically node positive, confirmed by needle biopsy proceed with axillary lymph node dissection or if limited axillary nodal disease at presentation4 and no longer evident on imaging consider SLNB with documented removal of clipped node and if no metastases proceed to radiation therapy without axillary lymph node dissection Consider Reconstruction and Plastic Surgery consult5
See Appendix B and C for adjuvant systemic therapy based on tumor subtype
See Page 8 for radiation therapy
1 Imaging may be helpful for assessing response as predictive/prognostic information, even if surgical management is not impacted in the setting of mastectomy 2 Neoadjuvant response assessment with MRI in cases where mammography and/or ultrasound are insufficient 3 Candidates for BCT:
Tumor to breast size ratio allows for acceptable cosmetic result No evidence of diffuse calcifications on mammogram Negative margins after surgery Resolution of any skin edema after systemic therapy 4 Limited nodal involvement at presentation is defined as 3 abnormal nodes on axillary ultrasound. The largest biopsy proven positive node should be clipped at presentation and documentation of clipped nodes is required at surgery. 5 For patients with stage II disease requiring post-mastectomy radiation, consider delayed reconstruction. For patients with stage III disease, delayed reconstruction is preferred.
Copyright 2023 The University of Texas MD Anderson Cancer Center
Department of Clinical Effectiveness V17 Approved by Executive Committee of the Medical Staff on 06/20/2023
Breast Cancer ? Invasive Stage I-III
Page 8 of 27
Disclaimer: This algorithm has been developed for MD Anderson using a multidisciplinary approach considering circumstances particular to MD Anderson's specific patient population, services and structure, and clinical information. This is not intended to replace the independent medical or professional judgment of physicians or other health care providers in the context of individual clinical circumstances to determine a patient's care. This algorithm should not be used to treat pregnant women.
Note: Consider Clinical Trials as treatment options for eligible patients.
RADIATION THERAPY
TREATMENT
T1-2 with negative lymph node(s)
Pathologic findings after
definitive surgery
or clinical stage at baseline if neoadjuvant chemotherapy
T1-2 with 1-3 positive lymph
node(s)
Whole breast radiation therapy1 for breast conservation therapy (BCT)
Consider partial breast radiation therapy for tumors 3 cm and negative lymph nodes
Consider radiation omission for patients age > 70 years with hormone positive, HER2 negative, grade 1-2 disease
Consider no radiation, if tumor is < 5 cm and mastectomy2
For patients with BCT, radiation to breast and refer to Appendix E for decision on regional lymphatics
For patients with mastectomy, refer to Appendix E for decision on regional lymphatics and chest wall for patients with mastectomy or no radiation
T3 or 4 involved lymph nodes
Post mastectomy radiation therapy to chest wall and
regional lymphatics Whole breast radiation therapy1 with regional lymphatics
for BCT
Whole breast radiation therapy Dose: - 4,005 cGy in 15 fraction plus or minus 1,000-1,600 cGy boost in 5-8 fractions, depending on margin. Consider omission of boost if low grade, older age, or hormone positive. - Low risk patients (age > 50 years and hormone positive), consider 2,600 cGy in 5 fractions delivered daily for 5 days
Partial breast radiation, if low risk patients age > 50 years and hormone positive Dose: - 3,850 cGy in 10 fractions delivered twice daily or - 3,000 cGy in 5 fractions, delivered every other day
Whole breast and level I/II axilla Dose: - 4,005 cGy in 15 fractions plus or minus 1,000-1,600 cGy boost in 5-8 fractions, depending on margin. Consider for low risk node positive patients with nomogram predicting low risk of additional nodes
Whole breast or chest wall and undissected draining lymphatics, to include internal mammary nodes (IMN), supraclavicular (SCV), and level III axilla
Include level I/II axilla if ALND not performed Dose: - 5,000 cGy in 25 fractions plus 1,000-1,600 cGy boost in 5-8 fractions, depending on margin - 1,000-1,600 cGy boost in 5-8 fractions to involved unresected nodes
Recurrent disease no prior radiation
ALND = axillary lymph node dissection
Post mastectomy radiation therapy to chest wall and regional lymphatics
Chest wall and undissected draining lymphatics Dose: - 5,400 cGy in 27 fractions plus 1,200 cGy boost in 6 fractions
1 Radiation therapy for BCT and post-mastectomy radiation are generally delivered at completion of chemotherapy. For early stage node negative patients, patients waiting for gene expression scores, or patients eligible for partial
breast irradiation, radiation therapy may be delivered before chemotherapy. 2 See Appendix E: Selection of Patients for Radiation to Regional Lymphatics
Department of Clinical Effectiveness V17
Copyright 2023 The University of Texas MD Anderson Cancer Center
Approved by Executive Committee of the Medical Staff on 06/20/2023
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