Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 Oct;139(1):10-6.
doi: 10.1016/j.ygyno.2015.08.004. Epub 2015 Aug 10.

Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer

Carol Aghajanian  1 , Barbara Goff  2 , Lawrence R Nycum  3 , Yan V Wang  4 , Amreen Husain  4 , Stephanie V Blank  5
Affiliations
Clinical Trial

Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer

Carol Aghajanian et al. Gynecol Oncol. 2015 Oct.

Abstract

Objective: OCEANS is a randomized, placebo (PL)-controlled, phase 3 trial evaluating the efficacy and safety of bevacizumab combined with gemcitabine+carboplatin (GC) for patients with platinum-sensitive recurrent ovarian cancer (ROC). The study met its primary endpoint, demonstrating improved progression-free survival with GC+bevacizumab compared with GC+PL. Herein, we describe results of final overall survival (OS) and updated safety.

Methods: Patients with recurrent platinum-sensitive ROC (recurring ≥6months after first-line platinum-based therapy) and measurable disease at baseline were randomized to receive GC+bevacizumab or GC+PL for 6-10cycles; PL or bevacizumab was then continued until disease progression. In this updated analysis, a Cox proportional hazards model was used to compare OS between the 2 treatment arms.

Results: At the data cutoff date (July 19, 2013), 353 patients (72.9%) had died. Median follow-up for OS was 58.2months in the experimental arm and 56.4months in the control arm. Consistent with interim analyses, median OS was comparable between arms (GC+bevacizumab: 33.6months; GC+PL: 32.9months; hazard ratio=0.95; log-rank p=0.65), and was consistent across all examined patient subgroups. The frequency and severity of adverse events were consistent with previous analyses; no new safety concerns were identified.

Conclusions: Results from final OS analysis of the phase 3 OCEANS study showed no significant difference in OS for patients treated with GC+bevacizumab compared with GC+PL.

Trial registration: ClinicalTrials.gov NCT00434642.

Keywords: Bevacizumab; OCEANS; Ovarian cancer; Overall survival; Safety.

PubMed Disclaimer

Conflict of interest statement

A.H. and Y.V.W. are employees of Genentech, Inc. A.H. also has a patent pending with Genentech, Inc. S.V.B. has served on an advisory board for and received fees from Genentech, Inc.

Figures

Fig. 1
Fig. 1. CONSORT diagram of all randomly assigned patients
aIncludes 168 patients with disease progression per RECIST and 4 patients with clinical disease progression. bIncludes 109 patients with disease progression per RECIST and 5 patients with clinical disease progression. cFive patients who were randomly assigned to the GC + PL arm received 1 or 2 doses of bevacizumab in error and were assigned to the GC + bevacizumab arm for all safety analyses. dFour patients who were randomly assigned to the GC + PL arm did not receive any protocol treatment and thus were excluded from the safety analysis. GC, gemcitabine + carboplatin; PL, placebo.
Fig. 2
Fig. 2
Updated overall survival (A) in the total study population and (B) according to patient subgroups. CI, confidence interval; GC, gemcitabine + carboplatin; HR, hazard ratio; OS, overall survival; PL, placebo.
Fig. 2
Fig. 2
Updated overall survival (A) in the total study population and (B) according to patient subgroups. CI, confidence interval; GC, gemcitabine + carboplatin; HR, hazard ratio; OS, overall survival; PL, placebo.
See this image and copyright information in PMC

References

    1. American Cancer Society. Ovarian cancer. 2014 Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003130-pdf.pdf. Last Medical Review: 08/05/2014; Last Revised: 12/23/2014.
    1. Baldwin LA, Huang B, Miller RW, Tucker T, Goodrich ST, Podzielinski I, et al. Ten-year relative survival for epithelial ovarian cancer. Obstet Gynecol. 2012;120:612–618. - PubMed
    1. McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with Stage III and Stage IV ovarian cancer. N Engl J Med. 1996;334:1–6. - PubMed
    1. Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, et al. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000;92:699–708. - PubMed
    1. Coleman RL, Monk BJ, Sood AK, Herzog TJ. Latest research and treatment of advanced-stage epithelial ovarian cancer. Nat Rev Clin Oncol. 2013;10:211–224. - PMC - PubMed

Publication types

MeSH terms

Associated data