967O - Updated overall survival analysis in OCEANS, a randomized phase 3 trial of gemcitabine (G) + carboplatin (C) and bevacizumab (BV) or placebo (PL) fo...

Date 30 September 2012
Event ESMO Congress 2012
Session Gynecological cancer
Topics Anti-Cancer Agents & Biologic Therapy
Ovarian Cancer
Presenter Carol Aghajanian
Authors C. Aghajanian1, L.R. Nycum2, B. Goff3, H. Nguyen4, A. Husain5, S.V. Blank6
  • 1Gynecologic Medical Oncology Service, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 2Department Of Obstetrics And Gynecology, Forsyth Regional Cancer Center, Winston-Salem/US
  • 3Department Of Obstetrics And Gynecology, University of Washington School of Medicine, Seattle/US
  • 4Biostatistics, Genentech, Inc., South San Francisco/US
  • 5Avastin Ovarian Cancer Program, Genentech, Inc., South San Francisco/US
  • 6Division Of Gynecologic Oncology, NYU School of Medicine, New York/US

Abstract

Background

In OCEANS, BV in combination with GC resulted in a statistically significant and clinically meaningful improvement in PFS in patients (pts) with platinum-sensitive (Plat-S) ROC (median PFS, 12.4 vs 8.4 months; HR = 0.484; P < .0001). These results were supported by the overall response rate (ORR), duration of response (DOR), and independent review committee (IRC) analyses. At the time of the final PFS analysis, the OS data were still not mature. Additional OS updates have been performed; here we present the 3rd interim OS analysis.

Methods

Eligibility criteria included first recurrence of Plat-S OC, PPC, or FTC with an ECOG PS of 0 or 1, no prior BV or chemotherapy for ROC, and measurable disease. Pts were randomized 1:1 to arm A: GC (G [1000 mg/m2, days 1 and 8] and C [AUC 4, day 1], q3w for 6–10 cycles) + concurrent PL (q3w), followed by PL until disease progression (PD) or unacceptable toxicity; or arm B: GC + concurrent BV (15 mg/kg q3w), followed by BV until PD or unacceptable toxicity. The primary end point was investigator-assessed PFS by RECIST. Secondary end points included ORR, OS, DOR, and safety. The 3rd interim OS analysis was conducted with a data cutoff date of March 30, 2012.

Results

As of the data cutoff date, 286 events (59% of pts) had occurred. There was no difference in OS between the arms, with an HR of 0.960 (95% CI, 0.760–1.214; log-rank P = 0.736). With a median follow-up of 42 months, median OS was 33.7 months in the GC + PL arm and 33.4 months in the GC + BV arm. There was no difference in the number of grade 5 treatment-emergent adverse events between arms (1 in each), the number of deaths was balanced between arms, and the cause of death in the majority of cases was PD in both arms. 89% and 86% of pts received subsequent therapy (including BV in 39% and 22%) in the PL and BV arms, respectively.

Conclusions

These data provide assurance that there is no detriment to OS with the addition of BV in this setting, and supports the positive benefit:risk ratio of the GC + BV regimen in significantly improving PFS in patients with platinum-sensitive ROC.

Disclosure

L.R. Nycum: Dr. Nycuum was a member of the Avastin-Ovary advisory board for Genentech for a contract of 1 year. The contract ended the end of March 2012. H. Nguyen: Hoa Nguyen is an employee of Genentech and owns stock in Roche. A. Husain: Dr. Husain is an employee of Genentech and holds stock ownership (Roche). All other authors have declared no conflicts of interest.