MANAGEMENT OF OVARIAN GERM CELL AND STROMAL TUMOURS- An update Michael Friedlander Ovarian Germ Cell Tumours 1-2% of all ovarian malignancies Usually in adolescents but 42% of 614 patients were over 30! 60-70% STAGE 1 at diagnosis No randomized trials in OGCT Guided by results of large body of data from randomized trials in testis cancer Ovarian Germ Cell Tumours Dysgerminoma Endodermal sinus tumour Embryonal Carcinoma Choriocarcinoma Teratoma-Mature/Immature Immature – low grade/high grade Surgical Principles Suspect diagnosis Pre-operative markers Conservative- fertility preserving surgery Staging-controversial- careful inspection of peritoneum, omentum, contralateral ovary and nodes with washings and biopsies of suspicious areas adequate Unilateral oophorectomy with debulking if advanced stage Management Principles Monitoring tumour markers b hcg AFP LDH t ½ b HCG 24- 48 hrs AFP 5-7 days Switch to salvage therapy if markers not falling adequately or rising during treatment Radiological re-staging following therapy Resection of residual masses particularly if teratoma elements in primary IGCCCG Prognostic classification Testis cancer Prognosis Proportion survival Non-seminoma seminoma Good 56% 90% AFP<1000 & BHCG<1000 & LDH<1.5 N Any marker level & no visceral mets Intermediate 28% 80% AFP 1000-10,000 & BHCG 100010,000 & LDH 1.5-10 ULN Non pulmonary mets Poor 16% 50% Non pulmonary mets AFP >10,000 BHCG>10,000 LDH> 10 ULN Staging System-POG Stage 1-limited to ovary. Washings –ve. Markers fall within T ½ Stage 2-microscopic residual/positive nodes<2cm.-ve washings Stage 3->2cm nodes;gross residual,contiguous visceral involvement;+ve washings Stage 4-distant metastases Malignant Germ Cell Tumors in Children and Adolescents-POG Study J Paed.Surg 39;424:2004 Stage 1 2 3 4 No. 41 16 58 16 6yr EFS% 95 87.5 96.6 86.7 6yr S% 95.1 93.8 97.3 93.3 BEP B 15mg/m2 D1 E 100mg/m2 1-5 P 20/m2 1-5 4 cycles at 3 weekly intervals Management of Dysgerminomas Most patients Stage 1a- surveillance appropriate. 15% will relapse and salvaged with chemotherapy Rare-therefore not clear if BEP X 3 is essentialin advanced or recurrent disease GOG STUDY- 39 patients with stage 1b-3 completely resected-treated with Carboplatin 400mg/m2 and etoposide 120mg/m2 x3 every 4 weeks x 3 No recurrences Management of Good Prognosis Subset BEP x 3 If Bleomycin contraindicated or dropped- EP X4 5 day BEP less toxic and optimal regimen B 30 U d1,8,15 E 100mg/m2 1-5 Cisplatin 20mg/m21-5 Australian Germ Cell Study Lancet 357;739;2001 Indiana BEP vs. 4 Cycles Cisplatin 100mg/m2 day1 Etoposide 120mg/m2 d1-3 Bleomycin 30 u q21 166 randomized Trial stopped as 1 vs. 9 deaths from cancer in the 2 regimens 5 day BEP-Indiana superior regimen Toxicity of BEP Pulmonary toxicity 3%; decreased DLCO 20% AML 0.2- 1% Neuropathy 20% Raynauds 20% Tinnitus 24% High tone hearing loss 70% Gonadal dysfunction 16 -30% Cardiovascular disease/Hypertension How important is Bleomycin Bleomycin should only be omitted if contra-indications when 4 cycles of EP can be used Inconsistent findings from trials of 4 EP vs 3 BEP Management of Intermediate to Poor Risk Subgroup BEP X 4- represents standard of care Multiple studies using various combinations and permutations do not appear superior VeIP appropriate if compromised lung function High dose therapy not demonstrated to be superior first line treatment Accelerated BEP Intermediate-high risknew Australian study Administer every 14 days with pegylated GCF support day 6 Cisplatin 20 mg/m2 day1-5 Etoposide 100mg/m2 d1-5 Bleomycin 30 u weekly x 12 Role of Second Look Surgery Not necessary in patients with completely resected disease at primary surgery Resection of residual masses-particularly if teratomatous elements in primary tumour Resection of residual masses in nondysgerminoma – 50% necrosis;35% mature teratoma; 15% residual cancer Second look surgery Matthew et al J Postgrad Med 2006 68 patients with germ cell tumors 35 residual mass post chemo 29 laparotomy 3 patients had viable tumor, 7 immature teratoma, 3 mature teratoma and 16 necrosis or fibrosis no cases of viable tumour if dysgerminoma, embryonal carcinoma /absence of teratoma in primary Salvage therapy TIP Journal of Clinical Oncology 18; 2000: 2413-2418 Treatment consisted of four cycles of TIP given 21 days apart. Paclitaxel 250/m2 by 24-hour infusion on day 1, followed by an ifosfamide 1.2 g/m2 infusion given over 4 hours, and cisplatin 20 mg/m2 on days 2 through 6. 80% of 30 achieved a favorable response. 22 (73%) of the favorable responses remain durable at a median follow-up duration of 33 months Survival for patients with relapsed testicular GCTs treated with TIP therapy (n = 30; 25 alive) Motzer, R. J. et al. J Clin Oncol; 18:2413-2418 2000 Copyright © American Society of Clinical Oncology Stem Cell Transplant ? European Bone Marrow Transplant GroupRandomized 280 relapsed patients to VIP/VeIP X4 vs VIP/VeIP X3 followed by High Dose Chemo and stem cell support No advantage to High dose and stem cell support 53% 3 year survival in both arms Stem Cell Transplant Results of 2 randomized trials EORTC and an intergroup study do not support role in first line therapy for high risk disease Still contentious for salvage therapy Ovarian Germ Cell Tumors Can stage 1 be managed with close surveillance? Surveillance successful in male germ cell tumours20-30% relapse but salvaged 2 cycles of BEP in “high risk” What about ovarian germ cell tumours Surveillance for Stage 1 tumors Study No. Pathology Relapse Survival Cushing et al 1999 POG/CCG 44 Immature teratoma-stage1 1 97.7% Dark et al 1997 24 9 dysgerminoma 9 immature teratoma 6 yolk sac 8 95% Barazelli 2000 12 6 95% patient Surveillance program Charing Cross /Mount Vernon Pre-op markers and scans 3 months post surgery CT Chest/abd-pelvis If clear2nd look laparoscopy if inadequate staging/immature teratoma Surveillance Markers HCG AFP LDH CA125 1st year every 2 weeks x 6 m and then monthly x 6 2nd year monthly 3rd year every 3/12 4th year every 4/12 Subsequent years 6/12 Surveillance Clinical exam 1st year monthly 2nd year every 2 months 3rd year every 3 months 4th year every 4 months 5-10 every 6 months Imaging Chest X ray alternate visits Abdo-pelvic US every 3rd visit for first 2 years followed by annual abdopelvic ultrasound subsequent years Surveillance in stage 1 Relapses occur within 1 year in almost all cases Salvage high Advantages- reduced toxicty leukemia 0.9% hypertension 15% neuropathy 15% Conclusions Paradigm of a curable malignancy Can not be complacent- still needs expert treatment rather than “recipe –based’’ Good evidence base for treatment Focus on reduction of toxicity in low risk and improving outcomes in intermediate to poor risk Surveillance has not been standard of care in ovarian germ cell tumors but should be considered for 1A Sex cord stromal tumours Sex Cord Stromal Tumors 5-8% of ovarian malignancies Derive from sex cords and ovarian stroma Granulosa Cell;Sertoli Leydig Adult granulosa cell tumors are the most common of the group Granulosa Cell Tumors(GCT) Median Age 54 2-5% of ovarian cancers 5% juvenile-prepubertal age group Usually unilateral 70% secrete estrogen- concurrent endometrial cancer in 5-10% Increased risk of breast cancer Most stage 1 at diagnosis Late recurrences 10-30 years post diagnosis can occur GCT-Survival by Stage FIGO Stage 5year survival 10 year survival 1 90-100% 85-95% 2 55-75% 50-65% 3 25-50% 20-30% GCT- Natural History Indolent Late relapses in up to 30% Stage 1 –but data not robust 90% 5 year survival Recurrences can occur many decades later 10 year survival after recurrence-56% Median Survival after recurrence 2 yrs GCT –Prognostic Factors Stage Poorly differentiated or sarcomatoid variant-worse prognosis Mitotic count 4/10HPF 100% @ 5yrs 5-9 –80% 5yr survival >10-no long term survivors Ploidy- better prognosis in diploid tumors Residual disease post surgery Management Unilateral oophorectomy in children or women of reproductive age group Bilateral tumours uncommon TAHBSO in post menopausal women No evidence to support adjuvant radiation No evidence that adjuvant chemotherapy prevents recurrence-but no studies ! Recurrent Disease management Median time to relapse 4-6 years Repeat debulking surgery should be considered in all patients Localised recurrence-consider radiation Hormonal therapy Chemotherapy Compilation of Results of Chemotherapy Regimen No. RR % Duration Toxic death months CAP 30 73 5-73 0 BEP 63 72 5-80+ 2 PVB 56 70 2-81+ 3 Chemotherapy of GCT Homesley et al Gynecol Oncol 1999;72:131 GOG study- 55 women with Stage 2-4 or recurrent GCT- BEP RR 40% CR 24% 14/38 women had negative second look surgery 50% of patients with recurrent disease progression free at 3 years 69% of patients with advanced tumors progression free at 3 years Significant toxicity with 2 bleomycin related deaths Taxanes in Sex Cord Stromal Tumours MD Anderson Experience-JCO 22;3517;2004 Non-randomized 44 patients-both adjuvant and recurrent Taxane +/- platinum 42% response rate in measurable disease Median PFS 20 months in recurrent disease Less toxic than BEP in this older population Hormone Receptors Hardy et al Gyn Oncol 2005 ER + 32% PR + 100% Hormonal Therapy Agent number Response% LHRH agonist 13 50 Progestin-MPA 5 90 Tamoxifen-progestin 1 100 Conclusions Good prognosis for most Rare –no strong evidence base for treatment decisions Adjuvant therapy controversial-? In high risk Surveillance-long term