FoROMe Lausanne 6 février Anita Wolfer MD-PhD Cheffe de clinique Département d Oncologie, CHUV

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1 FoROMe Lausanne 6 février 2014 Anita Wolfer MD-PhD Cheffe de clinique Département d Oncologie, CHUV

2 Epithelial Ovarian Cancer (EOC) Epidemiology Fifth most common cancer in women and forth most common cause of cancer death in women Most deadly gynecological cancer in western world In 2012 in Europe estimated new cases of ovarian cancer: with deaths No proven screening test available Predominantly older women, >80% older than 50 years Risk factors: poor reproductive history and long reproductive career ESMO Clinical Practice Guidelines Ann Oncol 24 (suppl 6): vi24-vi32, 2013

3 Epithelial Ovarian Cancer (EOC) Presentation Pelvic pain Constipation/diarrhea Postmenopausal vaginal bleeding fatigue

4 Epithelial Ovarian Cancer (EOC) Biology

5 Epithelial Ovarian Cancer (EOC) Histology Jones & Drapkin, Front. Oncol., 26 August 2013

6

7 Stage at presentation Type II Type I

8 Ovarian Cancer Histology matters British Journal of Cancer (2011) 105(12),

9 Distribution of various histological subtypes of ovarian cancer Invasive serous carcinomas most common subtype ~90% high grade, ~10% low grade Account for up to 80% of advanced EOC ~10% endometrioid ~5% clear cell carcinomas more common in Japan Relatively good prognosis at early stage but worse than serous at advanced stage 10-15% Borderline tumors (serous, endometrioid or mucinous)

10 Prognostic factors in advancedstage ovarian cancer Analysis of 6 GOG trials including almost 1900 stage III/IV patients, treated with surgery and cisplatin/paclitaxel (J Clin Oncol 25: ) Characteristic HR Disease progression (95% CI) Age, years P HR Death p < <.001 Residual disease Microscopic cm < <.001 >1.0 cm < <.001

11 Prognostic factors in advancedstage ovarian cancer II Characteristic HR Disease progression (95% CI) GOG PS P HR Death p <.001 Histology Serous Endometrioid Clear cell <.001 Mucinous < <.001 JClinOncol25:

12 Management Initial assessment with history, PE, imaging, CA-125, biopsies Upfront radical cytoreductive surgery In case this is not possible, second attempt after initial chemotherapy (secondary debulking) Platinum-based chemotherapy (even for stage I, particularly if suboptimally staged; consider carboplatin as single agent) Six cycles No second look

13 Recent developments in the treatment of EOC Carboplatin + Paclitaxel standard for the past 15 years Addition of 3 rd drug never showed improved outcome but added toxicity However, results far from satisfactory: Median TTP: mo Median OS: < 3 yrs

14 How to improve: improve cytoreduction by interval debulking

15 PS vs IDS: Identical OS Vergote et al, N Engl J Med 2010; 363:

16 OS according to residual disease Vergote et al, N Engl J Med 2010; 363:

17 Comparison of PDS vs IDS Primary debulking surgery (n=276) Optimal ( 1 cm) 41.6% 80.6% Neoadjuvant chemotherapy (n=274) Overall survival 29 months 30 months Perioperative death 2.5% 0.7% Overall survival by debulking status Complete 45 months 38 months Optimal 32 months 27 months

18 How to improve: better cytoreduction by interval debulking ASCO 2013 MRC-CHORUS trial (J Clin Oncol 31, 2013 (suppl; abstr 5500) PS (n=276) NACT (n=274) Treatment received Surgery 90% P-CT 92% P-CT 76% Surgery 78% Surgery + 6 cycles P-CT 64% 68% Postop AEs (grade 3+) Infection 6% 3% Hemorrhage 3% 7% VTE 2% 0% Discharge within 14 days 74% 92% Debulked to 0cm residual disease 15% 35% 12-month survival rate 70% 76%

19 MRC-CHORUS trial Primary debulking surgery (n=276) Neoadjuvant chemotherapy (n=274) Complete debulking 16% 40% 41% Optimal ( 1 cm) 25% 35% 75% Suboptimal (> 1 cm) 61% 25% Overall survival 22.8 months 24.5 months Death 5.6% 0.5% J Clin Oncol 31, 2013 (suppl; abstr 5500)

20 Improve chemotherapy: by changing administration route

21 Intraperitoneal vs intravenous chemotherapy Investigators (year published) No. of patients Overall survival in months Control arm Exp. Arm Aberts et al., p=0.02 Polyzos et al., Gadducci et al., Markman et al., p=0.05 Yen et al., Armstrong et al., p=0.02

22 Pooled Data (all cisplatin studies) Treatment hazard ratios (HRs) for overall survival for i.p. versus i.v. therapy. χ2 heterogeneity (5 d.f.) = 2.70; p =.75. Trimble E L et al. The Oncologist 2008;13:

23 Comparing toxicity between IP and IV Worse in IV: Hearing loss/tinnitus Hematologic (but not uniform between trials) Worse in IP: Fatigue Gastrointestinal grade 3 Infection Neurotoxicity grade 3 Abdominal pain Trimble E L et al. The Oncologist 2008;13:

24 Why is IP chemotherapy not standard treatment (yet?)? Additional time, effort, training, risk of local morbidity, toxicity Use of cisplatin rather than carboplatin (trials with carboplatin ongoing) Lack of adequate financial reimbursement (?) Belief that if comparative arm had been carboplatin there would have been no survival benefit (absence of evidence-based data)

25 Improve chemotherapy: by changing administration schedule

26

27

28 Katsumata, Lancet Oncol 2013; 14:

29 Katsumata, Lancet Oncol 2013; 14:

30

31 Ongoing trials studying dose-dense chemotherapy GOG262: phase III, stage II-IV EOC, comparing carbo d1 combined with 3-weekly vs weekly paclitaxel +/- bevacizumab; completed accrual, ongoing MITO-7: phase III, stage IC-IV EOC, comparing weekly carbo AUC2 + paclitaxel 60 mg/m2 (wcp) to carbo AUC6 + paclitaxel 175 mg/m2 every 3 weeks (3wCP) Reported at ASCO 2013: median PFS was 18.8 months with wcp and 16.5 months with 3wCP (HR 0.88, 95%CI , p=0.18) Toxicity profile clearly favoring weekly administration J Clin Oncol 31, 2013 (suppl; abstr LBA5501) ICON8: phase III, 3-arm trial, comparing Carbo AUC5 + paclitaxel every 3 weeks, vs carbo AUC5 d1 plus weekly paclitaxel, vs weekly carbo AUC2 plus weekly paclitaxel

32 ICON8: a randomized, phase III trial to evaluate the safety and efficacy of dose-dense, dose-fractionated carboplatin-paclitaxel chemotherapy in the treatment of patients with ovarian cancer. 1 endpoints: PFS, OS 2 endpoints: toxicity, quality of life, cost effectiveness

33 Improve chemotherapy: by adding drugs concomitantly or sequentially

34 Adding 3 rd cytotoxic drug Rationale: addition of non-cross resistant drug to platinum/paclitaxel combi may improve OS Multiple trials. Biggest is GOG182-ICON5 (JCO 2009;27(9): ): 5 arms study of adding either Gemcitabine, Topotecan or Caelyx to backbone of Carbo/pacli Study closed after 4312 pts accrued due to no PFS and OS benefit over CP

35 Addition of and maintenance with targeted agent GOG 218 ICON7 Pazopanib Population Primary and maintenance Primary and maintenace Maintenance 1 and 2 endpoint PFS and OS PFS and OS, RR PFS and OS, safety, QoL Maintenance duration 15 months max. 12 months max. 24 months max. Results (ΔPFS) 6 months 5.4 months 5.6 months Resluts (OS) 58 months (34.5 to 39.3 in poor prognosis group)

36 Adding bevacizumab: GOG 218 and ICON7 GOG 218 (stage III-IV EOC, PS 0-2): 3 arms: 1) carbo/paclitaxel 2) CP+Bev 15mg/kg concomitant to chemotherapy 3) CP+Bev followed by Bev 12m maintenance ICON-7 (EOC stage I-IIA high risk [9%] or IIB-IV, PS 0-2): 2 arms: 1) carbo/pacli 2) carbo/pacli+bev followed by Bev 36 wks at 7.5mg/kg

37 GOG 218: PFS 10.3 mo 11.2 mo 14.1 mo Δ=3.8 mo

38 GOG 218: OS 39.3 mo 38.7 mo 39.7 mo

39 ICON7: PFS Median PFS: C: 17.3 mo Bev: 19.0 mo

40 ICON7: PFS (high risk) Median PFS: C: 10.5 mo Bev: 15.9 mo

41 ICON7: OS 58 mo median OS

42 ICON7: OS (high risk) Median OS high risk C: 34.5 mo Bev: 39.3 mo Δ 4.8 mo (as of ECC 2013)

43 Toxicity GI perforation 1-2.6% Hypertension grade % Proteinuria grade % Questions: 1. Should it be given as first line or in recurrent setting? 2. How long should maintenance be? 3. What dose? 4. What s the benefit of bev in combination with weekly paclitaxel?

44

45 Other anti-angiogenic maintenance AGO-OVAR16 : Pazopanib (24m) v placebo in pts who do not have progression after surgery and completion of >4 cycles of platinum-taxane chemo (940pts, FIGO II-IV, 85% in CR at entry). Improved PFS from 12.3m to 17.9m. OS immature (ASCO JCO 2013;31 sup:abstr LBA5503)

46 So where to go?

47 comparing effects of IP vs dosedense chemotherapy: PFS 18.3 vs 23.8 mo 17.5 vs 28.2 mo

48 comparing effects of IP vs dosedense chemotherapy: OS 49.7 vs 65.6 mo 62.2 vs mo

49 Ongoing trials adressing this question: GOG 252, phase III, 3-arm Carbo AUC6 iv d1 + paclitaxel iv 80 mg/m 2 d1,8,15 Carbo AUC6 ip d1 + paclitaxel iv 80 mg/m 2 d1,8,15 Cisplatin 75 mg/m 2 d1 ip + paclitaxel 135 mg/m 2 d1 iv, 60 mg/m 2 ip d8 Plus bev 15 mg/kg concomitant and maintenance ipocc trial, phase III comparing iv carbo vs ip carbo together with weekly paclitaxel (NCT ); ongoing

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