GESTATIONAL TROPHOBLASTIC DISEASE GUIDELINES
GESTATIONAL TROPHOBLASTIC DISEASE New Zealand Gynaecologic Cancer GroupGUIDELINESCONTENTS:PAGE:1Background and Introduction22Pathogenesis; Ploidy2 3Clinical Presentation24Diagnostic features of GTD subtypes35Surgical Treatment of Molar Pregnancy3 6Histological examination of Products of Conception47Initial Assessment48Follow-up in Molar Pregnancy4 9Referral criteria to Gynaecology Oncology for (suspected) GTN510Hysterectomy for Persistent GTD?511Prophylactic Chemotherapy in Molar Pregnancy612Contraception in Molar Pregnancy613Pregnancy Advice after Molar Pregnancy614Pregnancy during Follow-up after Molar Pregnancy715Co-existing Viable Pregnancy and Molar Pregnancy7Gestational Trophoblastic Neoplasia (GTN)16Diagnosis of Gestational Trophoblastic Neoplasia 717Staging of GTN818Risk Assessment in GTN8 19Chemotherapy in GTN820Follow-up post chemotherapy9 21Advice to Patients after chemotherapy922Pregnancy after chemotherapy for GTN1123Prognosis in GTN11Acknowledgements, Version, Authors13References13 1BACKGROUND AND INTRODUCTIONGestational trophoblastic disease (GTD) is a group of disorders derived from a pregnancy. This term covers hydatidiform mole (including complete and partial moles), invasive mole, gestational choriocarcinoma, and placental site trophoblastic tumour (PSTT). Gestational trophoblastic neoplasia (GTN) is a term used to describe GTD requiring chemotherapy.GTN follows hydatidiform mole (60%), previous miscarriage/abortion (30%), normal pregnancy or ectopic gestation (10%). GTN most commonly follows hydatidiform mole as a persistently elevated hCG titre. The incidence of GTD is 1:200-1000 pregnancies, with evidence of ethnic variation. Women from Asia have a higher incidence than non-Asian women (1/390 and 1/750 respectively). The incidence after a live birth is 1/50,000. Incidence is higher at both ends of the reproductive spectrum, ie, in women younger than 15 and older than 45. 2PATHOGENESIS; PLOIDYPartial moles are triploid, with 2 sets of paternal and 1 maternal haploid set. An embryo is usually present that dies by week 8-9. They most often occur following dispermic fertilisation. Complete moles are usually diploid, derived from paternal duplication or dispermic fertilisation of an ‘empty’ ovum (lacking in maternal genes). The chromosome count is either 46XX, from one sperm (75%) that duplicates its DNA, or 46XX or 46XY from the presence of two different sperms (25%). Placental site tumour is diploid from either the normal conceptus or a complete mole.3CLINICAL PRESENTATIONDuring Pregnancy Per vaginal bleeding in the first trimesterHigh hCG values Large for dates uterus, hyperemesis, preeclampsia and hyperthyroidismUltrasound: pathognomonic ultrasonographic changes, more often seen in complete molesMacroscopic tissue appearancePartial mole often looks like normal products of conception and so the diagnosis may be missed. The characteristic ‘bunch of grapes’ appearance in complete moles is only seen in the second trimester and as most cases are diagnosed earlier, this is now rarely seen. After Pregnancy EventAny woman who develops persistent vaginal bleeding after a pregnancy event is at risk of having GTNA urine pregnancy test should be performed in all cases of persistent or irregular vaginal bleeding after a pregnancy eventSymptoms of metastatic disease like dyspnoea or abnormal neurology occur rarelyVaginal GTN is most commonly located in the fornices or suburethrally. They are highly vascular and bleed heavily, and biopsy should be avoided.4DIAGNOSTIC FEATURES OF GTD SUBTYPESHydatidiform moles are separated into complete and partial moles based on genetic and histopathological features. In early pregnancy (less than 8 -12 weeks gestation) it may be difficult to separate complete and partial moles on H&E microscopy, and other tests (e.g. ploidy, p57) will often be required to make the diagnosis. Invasive moles usually present with hCG elevation following a molar pregnancy, clinical features can include PV bleeding, abdominal pain or swelling. Quantitative estimation of hCG or tumour hCG (t -hCG) will be of use in the diagnosis. Gestational choriocarcinoma most commonly follows a complete molar pregnancy (25-50%), within 12 months of a non-molar abortion (25%), or after a term pregnancy (25-50%). Symptoms may include PV bleeding, pelvic mass, or symptoms from distant metastases such as liver, lung and brain metastases. hCG is always elevated. It may be a difficult pathological diagnosis because of the frequent haemorrhage and necrosis, which accompany it.Placental Site Trophoblastic Tumour (PSTT) is very rare. This frequently presents as a slow growing tumour a number of years after a molar pregnancy, non-molar abortion or term pregnancy. Usually PSTT presents with gynaecologic symptoms, about 1/3 present with metastases, and some patients present with hyperprolactinaemia or nephrotic syndrome. Usually the hCG levels are relatively low or normal in PSTT relative to the volume of the disease, and HPL is seen in cells on microscopy. This tumour is relatively chemoresistant.Epithelioid Trophoblastic Tumour (ETT) is extremely rare. It may be misdiagnosed as squamous cell cancer of the cervix, choriocarcinoma or PSTT. About 1/3 patients present with metastatic disease, usually in the lungs. The hCG levels are relatively low. It behaves most similarly to PSTT, has a spectrum of behaviour from benign to malignant, and is relatively chemoresistant.5SURGICAL TREATMENT OF MOLAR PREGNANCIESEvacuation of the uterus.Suction evacuation of the uterus is the preferred initial management regardless of uterine size.Medical methods of uterine evacuation have been associated with higher rates of chemotherapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UaWR5PC9BdXRob3I+PFllYXI+MjAwMDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (1). Preparation of the cervix immediately prior to the evacuation is safe.The cervix should be carefully dilated to accommodate a cannula appropriate for the volume of trophoblastic tissue. A suction catheter up to a maximum of 12mm is satisfactory for the rapid evacuation and involution of the uterus. Oxytocin infusion can be used after evacuation, especially if brisk bleeding occurs.Concern has been raised that oxytocin may promote metastases of trophoblastic tissue ADDIN EN.CITE <EndNote><Cite><Author>Attwood</Author><Year>1961</Year><RecNum>2093</RecNum><DisplayText>(2)</DisplayText><record><rec-number>2093</rec-number><foreign-keys><key app="EN" db-id="0fs5a0t5drvzvveffz1vawr8tzrvpw00tp2v" timestamp="1535683086">2093</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Attwood, H. D.</author><author>Park, W. W.</author></authors></contributors><titles><title>Embolism to the lungs by trophoblast</title><secondary-title>J Obstet Gynaecol Br Commonw</secondary-title><alt-title>The Journal of obstetrics and gynaecology of the British Commonwealth</alt-title></titles><periodical><full-title>J Obstet Gynaecol Br Commonw</full-title><abbr-1>The Journal of obstetrics and gynaecology of the British Commonwealth</abbr-1></periodical><alt-periodical><full-title>J Obstet Gynaecol Br Commonw</full-title><abbr-1>The Journal of obstetrics and gynaecology of the British Commonwealth</abbr-1></alt-periodical><pages>611-7</pages><volume>68</volume><keywords><keyword>*Embolism</keyword><keyword>*Extraembryonic Membranes</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Pregnancy</keyword><keyword>*Pregnancy Complications</keyword><keyword>*Pulmonary Embolism</keyword><keyword>*Trophoblasts</keyword></keywords><dates><year>1961</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0022-3204 (Print)
0022-3204 (Linking)</isbn><accession-num>13685013</accession-num><urls><related-urls><url>;(2). However it has been reported that stimulation before evacuation did not increase the risk of persistent disease ADDIN EN.CITE <EndNote><Cite><Author>Hancock</Author><Year>2003</Year><RecNum>2094</RecNum><DisplayText>(3)</DisplayText><record><rec-number>2094</rec-number><foreign-keys><key app="EN" db-id="0fs5a0t5drvzvveffz1vawr8tzrvpw00tp2v" timestamp="1535683809">2094</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Hancock, B.W.</author><author>Newlands, E.S.</author><author>Berkowitz, R.S.</author><author>Cole, L.A.</author></authors></contributors><titles><title>Gestational Trophoblastic Diseases. </title></titles><edition>2nd</edition><dates><year>2003</year></dates><pub-location>Sheffield</pub-location><publisher>International Society for the Study of Trophoblastic Diseases</publisher><urls></urls></record></Cite></EndNote>(3).It is advisable for the procedure to be carried out in the presence of, or by an experienced colleague, especially if the uterine size is large. Patients who are Rh –ve should receive Rh immunoglobulinThe Rh factor is expressed in the trophoblast. Second evacuation of the uterusSecond curettage evacuation of the uterus may be considered in select low risk patients after discussion at a Multidisciplinary meeting. Patients meeting the following criteria may be considered.Hydatidiform mole following initial curettagePersistently elevated b HCGNo evidence of metastatic GTN (CxR)FIGO risk score of 0-4A multicentre prospective phase 2 trial of 85 pts showed that 40% of patients avoided chemotherapy with second curettage. There was 1 uterine perforation (1.6%) managed conservatively PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Pc2Jvcm5lPC9BdXRob3I+PFllYXI+MjAxNjwvWWVhcj48
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ADDIN EN.CITE.DATA (4). 6HISTOLOGICAL EXAMINATION OF PRODUCTS OF CONCEPTIONAll spontaneous miscarriages and retained products of conception managed through a hospital should undergo histological examination. Routine termination of pregnancy does not require histological review.If no histological examination was performed after medical evacuation, hCG test is recommended after three weeks (urine test sufficient)Because GTD can also develop after any pregnancy, it is recommended that products of conception obtained after any repeat evacuation are also examined histologically. Expert pathological opinion, by a pathologist with an interest in gynaecologic pathology, is always recommended in the diagnosis of GTD. Pathology must be reviewed at a multidisciplinary meeting. 7INITIAL ASSESSMENTAll patients diagnosed with a molar pregnancy should be seen for consultation by a local, named clinician responsible for the local GTD Service, typically a gynaecologist. This should happen in conjunction with the Regional GTD Service The establishment of a local registry to capture all GTD patients is recommended. All patients should be asked to consent to centralised registration once a central registry is available. Visit should include:full history, including antecedent and all pregnancies, LMP date, evacuation date, oral contraceptive intake and symptoms Information and discussion about the diagnosis and the need for regular follow upWritten information (see appendix 1)Clinical examination for metastatic disease, pelvic examChest X-ray tumour hCG test as new baselineOffering of counselling PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdGFmZm9yZDwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+
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ADDIN EN.CITE.DATA (5)Socially disadvantaged women and those who do not conceive subsequent to GTD diagnosis require greater psychosocial support.8FOLLOW-UP IN MOLAR PREGNANCY (Partial and Complete Mole)General AspectsPatients must be followed up with regular tumour hCG after any diagnosis of molar pregnancy.Follow-up should preferably be undertaken in consultation with or by a specialist centre (Gynaecological Oncologist, and/or Medical Oncologist) with experience in the management of GTD. Responsibility for follow up of tumour hCG results must be delegated to a specific clinician or GTD Clinical Nurse Specialist, with robust procedures in place for the monitoring of the results.Tumour Marker follow-upTake serum tumour hCG Differs from pregnancy test with beta-hCG (β-hCG) , as it measures all hCG isoformsThe 2 assays are not comparablePatients undergoing follow-up after diagnosis of GTD should preferably have tumour hCG measured. Consistency is essential as treatment decisions might be based on small changes in the hCG.The serum half-life of hCG is ~24-36 hours. The level is roughly linked to the number of tumour cells; 5IU/l ~104 – 105 tumour cells. Schedule t-hCGOn the day of diagnosisWeekly thereafter until normal levels are obtained twiceMonthly once normal levels are obtained.Duration The duration of Follow up should be dependent on type of GTD PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2htaXR0PC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2htaXR0PC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA (6) This follow up plan can be followed if a central/MDM review of pathology has confirmed the diagnosis Partial mole:stop as soon as tHCG negative PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaWVsc21hPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48
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ADDIN EN.CITE.DATA (7)Complete mole:6 months after normalisation any mole with a multiple pregnancy: monthly for 12 months If no central /MDM pathology review has been performedassume complete mole 6 months after normalisation.See appendix 2 for a form to record tumour hCGs. Clinical Follow-upAfter the initial consultation, and provided the tumour hCG is falling appropriately, the patient should be seen again at 8-10 weeks to check that menstruation has returned, and that adequate contraception is being followed. If t hCG has not fallen to normal by this point patients should be referred to a molar clinic or discussed with a gynaecologic oncologistFor pregnancy advice during follow-up, see “Pregnancy advice after Molar pregnancy” below.In a large series, the risk of GTN after end of follow-up as described above is 0% for partial moles, and 0.3% for complete moles PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2htaXR0PC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA (6, 7).9 CRITERIA FOR REFERRAL TO MEDICAL ONCOLOGY FOR (SUSPECTED) GTNThe following criteria for immediate referral apply at any time during diagnosis or follow-up:Histological diagnosis invasive mole, choriocarcinoma, placental site trophoblastic tumour (PSTT).Plateau of tumour hCG lasts for 4 measurements over a period of 3 weeks or longer, ie, days 1,7,14,21 (plateau is usually defined as +/- 10%)Rise of tumour hCG on three consecutive weekly measurements, over a period of two weeks or longer, days 1,7,14 (usually defined as > 10%) Consider possibility of new pregnancy if tumour hCG is risingSerum hCG >20,000 >4 weeks after evacuation (because of risk of uterine perforation)Evidence of metastases in the brain, liver or GI tract, or >2cm on Chest X-ray.Most molar pregnancies spontaneously remit after evacuation; however persistence or change into malignant disease requiring chemotherapy (Gestational trophoblastic neoplasia or GTN) occurs in:0.5 - 4% Partial moles15 - 20% Complete moles.10 HYSTERECTOMY FOR PERSISTENT GESTATIONAL TROPHOBLASTIC DISEASE?Hysterectomy for treatment of molar pregnancy is not recommended as routine practicePatients who have completed their families may ask about hysterectomy to avoid the possibility of chemotherapy or surveillance. Two small American studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DdXJyeTwvQXV0aG9yPjxZZWFyPjE5NzU8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (8, 9) have shown that the chances of needing chemotherapy after hysterectomy for molar pregnancy are 3-10%, i.e. about halved, but certainly not eliminatedNeed for careful surveillance remains essential after hysterectomyIn patients being considered for hysterectomy, full staging investigation including CT thorax/ abdomen/pelvis and MRI pelvis should be performed to exclude obvious evidence of extra-uterine spread which would be a contra-indication to treatment by hysterectomy.! A Gynaecologic Oncologist must be consulted before deciding to proceed to an elective hysterectomy!11PROPHYLACTIC CHEMOTHERAPY IN MOLAR PREGNANCY?Prophylactic chemotherapy is not recommended as routine practice PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYW5nPC9BdXRob3I+PFllYXI+MjAxNzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (11-14) have shown that the risk of post molar GTD (i.e. persistence, invasion, choriocarcinoma, GTN) dropped in patients with molar pregnancy treated after surgery with prophylactic chemotherapy. However, Prophylactic chemotherapy does not obviate the need to monitor patients after evacuation as the risk does not drop to zero.There is a suggestion that patients who received prophylaxis need more chemotherapy if their disease recurs PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaW08L0F1dGhvcj48WWVhcj4xOTg2PC9ZZWFyPjxSZWNO
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaW08L0F1dGhvcj48WWVhcj4xOTg2PC9ZZWFyPjxSZWNO
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b3RlPn==
ADDIN EN.CITE.DATA (14).The ‘risk scales’ used to determine high risk patients for prophylaxis have been subject to much criticism.12CONTRACEPTION IN MOLAR PREGNANCYPatients should be strongly counselled to avoid pregnancy during follow-up. Pregnancy masks tumour persistence/recurrence.Oral contraceptives can be taken between evacuation and normalisation of HCG. Recent series and systematic reviews suggests there is NO increased risk of invasive mole or choriocarcinoma developing from the use of oral contraceptives before normalisation of HCG PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3N0YTwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (15,16).IUCDs should be avoided until the menstrual pattern and tumour hCG are normal to reduce risk of uterine perforation. If chosen as contraception (after normalisation of hCG) advise insertion of IUCD by a gynaecologist.Barrier Methods are the preferred method of contraception during chemotherapy.13PREGNANCY ADVICE AFTER MOLAR PREGNANCYWomen should be advised not to conceive until their follow up is completeFuture pregnanciesIn all subsequent pregnancies patients should have an early (6-8 week) and mid trimester scan looking for molar tissue After all future pregnancy events (including TOP, miscarriage etc) patients should have a tumour hCG blood test 6-8 weeks The chances of conception after molar pregnancy do not differ from the general population. The risk of a further molar pregnancy in future pregnancies is 1:70. Subsequent pregnancies result in full-term live births in about 70% of women, with major and minor congenital malformations detected in 0.4-2.5% of infants. These figures do not differ significantly from the normal population. Outcomes other than full-term live births include first trimester spontaneous abortions in about 15%, 2-8% premature deliveries, and smaller numbers of stillbirths and ectopic pregnancies.14PREGNANCY DURING FOLLOW-UP AFTER MOLAR PREGNANCYPregnancies occurring before completion of recommended follow-up may be allowed to continue under careful surveillance.Background : Tuncer ADDIN EN.CITE <EndNote><Cite><Author>Tuncer</Author><Year>1999</Year><RecNum>2119</RecNum><DisplayText>(17)</DisplayText><record><rec-number>2119</rec-number><foreign-keys><key app="EN" db-id="0fs5a0t5drvzvveffz1vawr8tzrvpw00tp2v" timestamp="1539229700">2119</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tuncer, Z. S.</author><author>Bernstein, M. R.</author><author>Goldstein, D. P.</author><author>Lu, K. H.</author><author>Berkowitz, R. S.</author></authors></contributors><auth-address>New England Trophoblastic Disease Center, Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.</auth-address><titles><title>Outcome of pregnancies occurring within 1 year of hydatidiform mole</title><secondary-title>Obstet Gynecol</secondary-title><alt-title>Obstetrics and gynecology</alt-title></titles><periodical><full-title>Obstet Gynecol</full-title><abbr-1>Obstetrics and gynecology</abbr-1></periodical><alt-periodical><full-title>Obstet Gynecol</full-title><abbr-1>Obstetrics and gynecology</abbr-1></alt-periodical><pages>588-90</pages><volume>94</volume><number>4</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>*Hydatidiform Mole</keyword><keyword>Pregnancy</keyword><keyword>*Pregnancy Outcome</keyword><keyword>Retrospective Studies</keyword><keyword>Time Factors</keyword><keyword>*Uterine Neoplasms</keyword></keywords><dates><year>1999</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>0029-7844 (Print)
0029-7844 (Linking)</isbn><accession-num>10511364</accession-num><urls><related-urls><url>;(17) reviewed 44 pregnancies conceived within 6 months of normal tumour hCG (mean 3 months normal hCG). Seventy five percent of 44 patients had live births and there were 10 spontaneous abortions. None of these patients developed persistent or recurrent GTD, and none of the live births demonstrated any foetal abnormalities.Patients should have an early and mid-trimester scan looking for molar tissue. Other surveillance is difficult during pregnancy, and will depend on the managing specialist’s estimation of the risk of recurrence.see also Pregnancy Advice after Molar Pregnancy Routine follow-up should be resumed after the pregnancy until the total follow-up duration initially planned. 15COEXISTING VIABLE PREGNANCY AND MOLAR PREGNANCYThe recommendation is that the pregnancy should be allowed to proceed after loss of the molar tissue, if it is otherwise safe and the mother wishes, following appropriate counselling. Backgroundrare occurrence 1 in 22,000 – 100,000 pregnancies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdGVpZ3JhZDwvQXV0aG9yPjxZZWFyPjIwMDQ8L1llYXI+
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ADDIN EN.CITE.DATA (18)higher risk of developing maternal complications probability of achieving a viable baby 40% (most pregnancies result in preterm labour, or premature fetal death) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZWJpcmU8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (19, 20) 16DIAGNOSIS OF GESTATIONAL TROPHOBLASTIC NEOPLASIA (GTN)The table below represents the criteria agreed for diagnosis of GTN by the Committee of the International Federation of Gynecology and Obstetrics (FIGO) in September of 2000 Gestational trophoblastic neoplasia is treated by chemotherapy. Criteria for the diagnosis of post hydatidiform mole trophoblastic neoplasia (GTN)GTN may be diagnosed* when the plateau of human chorionic gonadatrophin (hCG) lasts for 4 measurements over a period of 3 weeks or longer, that is days 1,7,14,21.GTN may be diagnosed* when there is a rise of hCG on three consecutive weekly measurements, over a period of two weeks or longer, days 1,7,14.GTN is diagnosed if there is histologic diagnosis of choriocarcinoma.(GTN is diagnosed when the hCG level remains elevated for 6 months or more**)*The actual level of hCG or the amount of rise will be determined by the individualInvestigator, but a plateau is usually defined as +/- 10%, and rise >10%**This has subsequently been removed as a criteria in 2013 ADDIN EN.CITE <EndNote><Cite><Author>Agarwal</Author><Year>2012</Year><RecNum>2129</RecNum><DisplayText>(21)</DisplayText><record><rec-number>2129</rec-number><foreign-keys><key app="EN" db-id="0fs5a0t5drvzvveffz1vawr8tzrvpw00tp2v" timestamp="1539230034">2129</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Agarwal, R.</author><author>Teoh, S.</author><author>Short, D.</author><author>Harvey, R.</author><author>Savage, P. M.</author><author>Seckl, M. J.</author></authors></contributors><auth-address>Imperial College London, London, UK.</auth-address><titles><title>Chemotherapy and human chorionic gonadotropin concentrations 6 months after uterine evacuation of molar pregnancy: a retrospective cohort study</title><secondary-title>Lancet</secondary-title><alt-title>Lancet</alt-title></titles><periodical><full-title>Lancet</full-title><abbr-1>Lancet</abbr-1></periodical><alt-periodical><full-title>Lancet</full-title><abbr-1>Lancet</abbr-1></alt-periodical><pages>130-5</pages><volume>379</volume><number>9811</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Chorionic Gonadotropin/*analysis</keyword><keyword>Cohort Studies</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hydatidiform Mole/*drug therapy/metabolism/*surgery</keyword><keyword>Middle Aged</keyword><keyword>Pregnancy</keyword><keyword>Retrospective Studies</keyword><keyword>Time Factors</keyword></keywords><dates><year>2012</year><pub-dates><date>Jan 14</date></pub-dates></dates><isbn>1474-547X (Electronic)
0140-6736 (Linking)</isbn><accession-num>22130490</accession-num><urls><related-urls><url>(11)61265-8</electronic-resource-num></record></Cite></EndNote>(21) Other factors may be also taken into account by the medical oncologist such as evidence of brain, liver, renal or gastro-intestinal tract metastases, lung metastases >2cm, or a serum tumour hCG > 20,000 IU/L more than four weeks after evacuation.The exclusion of a new pregnancy is essential when evaluating patients with a tumour hCG rise. 17STAGING OF GESTATIONAL TROPHOBLASTIC NEOPLASIAAll patients with GTN should have history and physical examination as above outlined under GTD.Blood tests Baseline t hCGFBC, U&EThyroid function testsCoagulation StatusHBsAgConsider cross-match if heavy bleeding. Radiology Chest X ray (relevant for scoring system below)Pelvic ultrasound (trans-vaginal is preferable) CT abdomen and pelvis and MRI Brain if pulmonary metastasis detected or abnormal findings on exam / symptoms Urine creatinine clearance in patients for EP/EMA or high dose methotrexate. Patients with recurrent GTN should be fully restaged, with all blood tests as above, CT chest abdomen and pelvis, MRI brain, and lumbar puncture for CSF hCG to exclude the CNS acting as a sanctuary site. 18RISK ASSESSMENT IN GESTATIONAL TROPHOBLASTIC NEOPLASIA If a patient on follow-up meets any of the criteria for chemotherapy, their risk will be assessed by the FIGO 2000 criteria below ADDIN EN.CITE <EndNote><Cite><Author>Kohorn</Author><Year>2001</Year><RecNum>2130</RecNum><DisplayText>(22)</DisplayText><record><rec-number>2130</rec-number><foreign-keys><key app="EN" db-id="0fs5a0t5drvzvveffz1vawr8tzrvpw00tp2v" timestamp="1539230113">2130</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kohorn, E. I.</author></authors></contributors><auth-address>Yale Trophoblast Center, Yale University School of Medicine, New Haven, Connecticut, USA. ernest.kohorn@yale.edu</auth-address><titles><title>The new FIGO 2000 staging and risk factor scoring system for gestational trophoblastic disease: description and critical assessment</title><secondary-title>Int J Gynecol Cancer</secondary-title><alt-title>International journal of gynecological cancer : official journal of the International Gynecological Cancer Society</alt-title></titles><periodical><full-title>Int J Gynecol Cancer</full-title><abbr-1>International journal of gynecological cancer : official journal of the International Gynecological Cancer Society</abbr-1></periodical><alt-periodical><full-title>Int J Gynecol Cancer</full-title><abbr-1>International journal of gynecological cancer : official journal of the International Gynecological Cancer Society</abbr-1></alt-periodical><pages>73-7</pages><volume>11</volume><number>1</number><keywords><keyword>Female</keyword><keyword>Humans</keyword><keyword>*Neoplasm Staging</keyword><keyword>*Practice Guidelines as Topic</keyword><keyword>Pregnancy</keyword><keyword>Risk Factors</keyword><keyword>Societies, Medical</keyword><keyword>Trophoblastic Neoplasms/*classification/*pathology</keyword><keyword>Uterine Neoplasms/*classification/*pathology</keyword></keywords><dates><year>2001</year><pub-dates><date>Jan-Feb</date></pub-dates></dates><isbn>1048-891X (Print)
1048-891X (Linking)</isbn><accession-num>11285037</accession-num><urls><related-urls><url>;(22). Low risk patients are those with a score of 6 or below, High risk patients have a score of 7 or over. FIGO score0124Age<40>40AntecedentpregnancyMoleAbortionTermInterval months from index pregnancy<4 mo4-<77-<13>13Pre-treatment serum hCG (IU/l)<103103 < 104104 -<105>105Largest tumour size (including uterine tumour)<3 cm3-<5cm>5 cmSite of metastasesLung *SpleenkidneyGITBrainliverNumber of metastases01 - 45 - 8>8Previous failed chemotherapySingle drug>2 drugsNotes: 1. The interval months from pregnancy is taken from when the pregnancy ended (not started)2. The score for site of metastases is not additive. The highest scoring organ is taken to be the score (e.g. A patient with gastrointestinal and brain metastases scores 4, not 6)3. * lung metastasis counted on CXR not on a Chest CT 19CHEMOTHERAPY IN GESTATIONAL TROPHOBLASTIC NEOPLASIA All patients requiring chemotherapy including methotrexate should be managed by a Medical OncologistMost patients will be low risk, and therefore treated with methotrexate intramuscularlyThis is a generally well tolerated 2 weekly outpatient regimen with few side effectsThis continues until hCG has normalised plus an additional 3 cycles (i.e 6 weeks after normalisation). About 1 in 3-4 of these women will become resistant to this chemotherapy, and will then generally then require combination chemotherapy with EMA-CO or Actinomycin. A small number of women may become intolerant of methotrexate and need to switch regimens. Patients with high risk score or recurrent disease need to be discussed at MDMSample guideline chemotherapy regimens are included in Appendix 3. 20FOLLOW-UP POST CHEMOTHERAPY Medical Oncologist will often refer back to General Gynaecologist or Gynae Oncologists for further follow up after completion of chemotherapyPatients undergoing follow-up after diagnosis of GTD or GTN should only have thCG measured (if this is available). Consistency is essential as treatment decisions are based on small changes in the hCG.Initial post chemo follow-up is recommended to re-check the sites of original disease (e.g. TVUSS, CT, MRI as appropriate) and give advice as in the section below.If the tumour hCG becomes abnormal again at any time after chemotherapy, pregnancy should be excluded first. The tumour hCG should be checked again immediately, and an urgent referral made to Medical Oncology. Follow up schedule: based on European and USA international guidelines. ( note Charing cross follow up indefinitely for data gathering purposes.)Low risk GTN: (post Mtx/actinomycin): Follow up with monthly tHCG’s for 12 months.High risk GTN: (post EMA-CO or equivalent): Follow up with monthly tHCG’s for 2 years.PSTT/ETT: Follow up for minimum of 5 years - HCG’s plus appropriate imaging.21ADVICE TO PATIENTS AFTER CHEMOTHERAPYRisk of relapseIn the largest published series of over 1700 patients, 60 (3.5%) relapsed 35 (58%) of initially low risk, and 25 (42%) of initially high risk. The median time to relapse was 4 months, 73% relapsed within a year of chemotherapy, and 85% within 2 years. Only 1 of the 60 relapses occurred after 5 years PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Qb3dsZXM8L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (23).Time to relapseN =(%)Cumulative (%) 0 - 3 months3151.651.6 3 - 6 months1016.668.2 6 - 12 months 3 5.073.2 12 - 24 months 711.784.9 1 – 5 years 813.598.4> 5 years 1 1.6100ContraceptionAny method may be used after chemotherapy. A delay of at least 6 weeks post chemotherapy is advisable before fitting an IUD. Contraception should be advised for at least one year after the last dose of chemotherapy. This is both to prevent pregnancy obscuring relapse, and to reduce the incidence of abnormal pregnancies.PregnancySee section below. Hormonal Replacment TherapyProvided t hCG levels are normal, there is not known to be any increased risk of recurrence in the use of hormone replacement therapy for those patients with symptomatic premature menopause. Risk of second malignancyThere is no apparent increased risk after Methotrexate and folinic acid. After EMA-CO, the risk ratio over the normal population is 1.5. Myeloid leukaemia is the most common second malignancy followed by breast and colon cancer, and melanoma. 22PREGNANCY AFTER CHEMOTHERAPY FOR GESTATIONAL TROPHOBLASTIC NEOPLASIA Ability to conceive and effect on age of menopauseMost women successfully treated with chemotherapy for GTN can be reassured that their fertility is unlikely to be significantly affected by chemotherapy. A London study of 728 women treated with chemotherapy who subsequently wanted to become pregnant found that 93% conceived and 83% reported at least 1 live birth. There were no apparent differences in conception rates between those who received single agent, and multi-agent chemotherapy ADDIN EN.CITE <EndNote><Cite><Author>Woolas</Author><Year>1998</Year><RecNum>2133</RecNum><DisplayText>(24)</DisplayText><record><rec-number>2133</rec-number><foreign-keys><key app="EN" db-id="0fs5a0t5drvzvveffz1vawr8tzrvpw00tp2v" timestamp="1539230252">2133</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Woolas, R. P.</author><author>Bower, M.</author><author>Newlands, E. S.</author><author>Seckl, M.</author><author>Short, D.</author><author>Holden, L.</author></authors></contributors><auth-address>Department of Gynaecological Oncology, St Mary's Hospital, Portsmouth, UK.</auth-address><titles><title>Influence of chemotherapy for gestational trophoblastic disease on subsequent pregnancy outcome</title><secondary-title>Br J Obstet Gynaecol</secondary-title><alt-title>British journal of obstetrics and gynaecology</alt-title></titles><periodical><full-title>Br J Obstet Gynaecol</full-title><abbr-1>British journal of obstetrics and gynaecology</abbr-1></periodical><alt-periodical><full-title>Br J Obstet Gynaecol</full-title><abbr-1>British journal of obstetrics and gynaecology</abbr-1></alt-periodical><pages>1032-5</pages><volume>105</volume><number>9</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Age of Onset</keyword><keyword>Antineoplastic Combined Chemotherapy Protocols/*therapeutic use</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>Pregnancy</keyword><keyword>*Pregnancy Outcome</keyword><keyword>Reproductive Medicine</keyword><keyword>Trophoblastic Tumor, Placental Site/*drug therapy</keyword><keyword>Uterine Neoplasms/*drug therapy</keyword></keywords><dates><year>1998</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>0306-5456 (Print)
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ADDIN EN.CITE.DATA (25). Pregnancy Advice and Outcome after ChemotherapyWomen should be advised not to become pregnant for at least a year after the last dose of chemotherapy. About 90% of patients who want to become pregnant after chemotherapy will do so. There is a 1:70 (1-2%) chance of conceiving a further molar pregnancy. Most studies suggest that as a group, women have normal reproductive outcomes after chemotherapy for GTN. Pregnancies result in about 70% term live births, with a 2.5% incidence of major and minor congenital abnormalities PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZXJrb3dpdHo8L0F1dGhvcj48WWVhcj4yMDAwPC9ZZWFy
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ADDIN EN.CITE.DATA (28).< 6 months vs. > 12 monthsAnother retrospective analysis found incidence of abnormal pregnancies (spontaneous abortion, stillbirth and repeat mole) was higher in those women who conceived within 6 months vs > 12 months of completing chemotherapy (37.5% vs 10.5 %) Of these women 85% had been treated with methotrexate, the remainder with MEA ADDIN EN.CITE <EndNote><Cite><Author>Matsui</Author><Year>2004</Year><RecNum>2149</RecNum><DisplayText>(29)</DisplayText><record><rec-number>2149</rec-number><foreign-keys><key app="EN" db-id="0fs5a0t5drvzvveffz1vawr8tzrvpw00tp2v" timestamp="1539230479">2149</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Matsui, H.</author><author>Iitsuka, Y.</author><author>Suzuka, K.</author><author>Yamazawa, K.</author><author>Tanaka, N.</author><author>Mitsuhashi, A.</author><author>Sekiya, S.</author></authors></contributors><auth-address>Department of Reproductive Medicine, Chiba University Graduate School of Medicine, Chiba, Japan. hmatsui@med.m.chiba-u.ac.jp</auth-address><titles><title>Early pregnancy outcomes after chemotherapy for gestational trophoblastic tumor</title><secondary-title>J Reprod Med</secondary-title><alt-title>The Journal of reproductive medicine</alt-title></titles><periodical><full-title>J Reprod Med</full-title><abbr-1>The Journal of reproductive medicine</abbr-1></periodical><alt-periodical><full-title>J Reprod Med</full-title><abbr-1>The Journal of reproductive medicine</abbr-1></alt-periodical><pages>531-4</pages><volume>49</volume><number>7</number><keywords><keyword>Antineoplastic Agents/*adverse effects</keyword><keyword>Female</keyword><keyword>Gestational Trophoblastic Disease/*drug therapy</keyword><keyword>Humans</keyword><keyword>Pregnancy</keyword><keyword>Pregnancy Complications/*chemically induced</keyword><keyword>*Pregnancy Outcome</keyword><keyword>Time Factors</keyword><keyword>Uterine Neoplasms/*drug therapy</keyword></keywords><dates><year>2004</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0024-7758 (Print)
0024-7758 (Linking)</isbn><accession-num>15305824</accession-num><urls><related-urls><url>;(29).23PROGNOSIS IN GESTATIONAL TROPHOBLASTIC NEOPLASIA low risk diseaseChances of cure are close to 100%. This is the case if they are treated with MTX alone, or if they require change to second line chemotherapy. high risk disease Survival varies widely according to tumour burden and site of metastasesOverall cure is close to 85%. VERSION and AUTHORSVersion 3Kathryn Chrystal for the NZGCG GroupCorrespondence kchrystal@t.nzBased on first version from 2006, V2 update 2014 (Michelle Vaughan and Simone Petrich)ACKNOWLEDGEMENTSThank you to Dr Philip Savage from the Charing Cross in London, for editing and access to the Charing Cross Trophoblast Disease Clinic Guide, upon which much of the first edition of the guidelines were based. Thanks to Maria Treloar for clerical support and Fran Anderson and Kate Coffey for the patient information booklet.APPENDICESPatient information Patient record REFERENCES ADDIN EN.REFLIST 1.Tidy JA, Gillespie AM, Bright N, Radstone CR, Coleman RE, Hancock BW. Gestational trophoblastic disease: a study of mode of evacuation and subsequent need for treatment with chemotherapy. Gynecologic oncology. 2000;78(3 Pt 1):309-12.2.Attwood HD, Park WW. Embolism to the lungs by trophoblast. The Journal of obstetrics and gynaecology of the British Commonwealth. 1961;68:611-7.3.Hancock BW, Newlands ES, Berkowitz RS, Cole LA. Gestational Trophoblastic Diseases. . 2nd ed. Sheffield: International Society for the Study of Trophoblastic Diseases; 2003.4.Osborne RJ, Filiaci VL, Schink JC, Mannel RS, Behbakht K, Hoffman JS, et al. Second Curettage for Low-Risk Nonmetastatic Gestational Trophoblastic Neoplasia. Obstetrics and gynecology. 2016;128(3):535-42.5.Stafford L, McNally OM, Gibson P, Judd F. Long-term psychological morbidity, sexual functioning, and relationship outcomes in women with gestational trophoblastic disease. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. 2011;21(7):1256-63.6.Schmitt C, Doret M, Massardier J, Hajri T, Schott AM, Raudrant D, et al. Risk of gestational trophoblastic neoplasia after hCG normalisation according to hydatidiform mole type. Gynecologic oncology. 2013;130(1):86-9.7.Wielsma S, Kerkmeijer L, Bekkers R, Pyman J, Tan J, Quinn M. Persistent trophoblast disease following partial molar pregnancy. The Australian & New Zealand journal of obstetrics & gynaecology. 2006;46(2):119-23.8.Curry SL, Hammond CB, Tyrey L, Creasman WT, Parker RT. Hydatidiform mole: diagnosis, management, and long-term followup of 347 patients. Obstetrics and gynecology. 1975;45(1):1-8.9.Bahar AM, el-Ashnehi MS, Senthilselvan A. Hydatidiform mole in the elderly: hysterectomy or evacuation? International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 1989;29(3):233-8.10.Wang Q, Fu J, Hu L, Fang F, Xie L, Chen H, et al. Prophylactic chemotherapy for hydatidiform mole to prevent gestational trophoblastic neoplasia. The Cochrane database of systematic reviews. 2017;9:CD007289.11.Kashimura Y, Kashimura M, Sugimori H, Tsukamoto N, Matsuyama T, Matsukuma K, et al. Prophylactic chemotherapy for hydatidiform mole. Five to 15 years follow-up. Cancer. 1986;58(3):624-9.12.Berkowitz RS, Goldstein DP, DuBeshter B, Bernstein MR. Management of complete molar pregnancy. The Journal of reproductive medicine. 1987;32(9):634-9.13.Limpongsanurak S. Prophylactic actinomycin D for high-risk complete hydatidiform mole. The Journal of reproductive medicine. 2001;46(2):110-6.14.Kim DS, Moon H, Kim KT, Moon YJ, Hwang YY. Effects of prophylactic chemotherapy for persistent trophoblastic disease in patients with complete hydatidiform mole. Obstetrics and gynecology. 1986;67(5):690-4.15.Costa HL, Doyle P. Influence of oral contraceptives in the development of post-molar trophoblastic neoplasia--a systematic review. Gynecologic oncology. 2006;100(3):579-85.16.Gaffield ME, Kapp N, Curtis KM. Combined oral contraceptive and intrauterine device use among women with gestational trophoblastic disease. Contraception. 2009;80(4):363-71.17.Tuncer ZS, Bernstein MR, Goldstein DP, Lu KH, Berkowitz RS. Outcome of pregnancies occurring within 1 year of hydatidiform mole. Obstetrics and gynecology. 1999;94(4):588-90.18.Steigrad SJ, Robertson G, Kaye AL. Serial hCG and ultrasound measurements for predicting malignant potential in multiple pregnancies associated with complete hydatidiform mole: a report of 2 cases. The Journal of reproductive medicine. 2004;49(7):554-8.19.Sebire NJ, Foskett M, Paradinas FJ, Fisher RA, Francis RJ, Short D, et al. Outcome of twin pregnancies with complete hydatidiform mole and healthy co-twin. Lancet. 2002;359(9324):2165-6.20.Vejerslev LO. Clinical management and diagnostic possibilities in hydatidiform mole with coexistent fetus. Obstetrical & gynecological survey. 1991;46(9):577-88.21.Agarwal R, Teoh S, Short D, Harvey R, Savage PM, Seckl MJ. Chemotherapy and human chorionic gonadotropin concentrations 6 months after uterine evacuation of molar pregnancy: a retrospective cohort study. Lancet. 2012;379(9811):130-5.22.Kohorn EI. The new FIGO 2000 staging and risk factor scoring system for gestational trophoblastic disease: description and critical assessment. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. 2001;11(1):73-7.23.Powles T, Savage PM, Stebbing J, Short D, Young A, Bower M, et al. A comparison of patients with relapsed and chemo-refractory gestational trophoblastic neoplasia. British journal of cancer. 2007;96(5):732-7.24.Woolas RP, Bower M, Newlands ES, Seckl M, Short D, Holden L. Influence of chemotherapy for gestational trophoblastic disease on subsequent pregnancy outcome. British journal of obstetrics and gynaecology. 1998;105(9):1032-5.25.Bower M, Rustin GJ, Newlands ES, Holden L, Short D, Foskett M, et al. Chemotherapy for gestational trophoblastic tumours hastens menopause by 3 years. European journal of cancer. 1998;34(8):1204-7.26.Berkowitz RS, Tuncer ZS, Bernstein MR, Goldstein DP. Management of gestational trophoblastic diseases: subsequent pregnancy experience. Seminars in oncology. 2000;27(6):678-85.27.Schorge JO, Goldstein DP, Bernstein MR, Berkowitz RS. Recent advances in gestational trophoblastic disease. The Journal of reproductive medicine. 2000;45(9):692-700.28.Blagden SP, Foskett MA, Fisher RA, Short D, Fuller S, Newlands ES, et al. The effect of early pregnancy following chemotherapy on disease relapse and foetal outcome in women treated for gestational trophoblastic tumours. British journal of cancer. 2002;86(1):26-30.29.Matsui H, Iitsuka Y, Suzuka K, Yamazawa K, Tanaka N, Mitsuhashi A, et al. Early pregnancy outcomes after chemotherapy for gestational trophoblastic tumor. The Journal of reproductive medicine. 2004;49(7):531-4. ................
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