The addition of bevacizumab (Avastin) to gemcitabine and carboplatin, followed by bevacizumab until disease progression, resulted in significantly improved progression-free survival compared to gemcitabine and carboplatin plus placebo among women with platinum-sensitive recurrent ovarian, primary periotoneal, or fallopian tube cancer. Results from the phase III OCEANS (Ovarian Cancer Study Comparing the Efficacy and Safety of Chemotherapy and Anti-Angiogenic Therapy in Platinum-Sensitive Recurrent Disease) trial were published in the Journal of Clinical Oncology.1 The study was sponsored by Genentech, which manufactures bevacizumab.
Analysis of Progression-free Survival
Both treatment groups consisted of 242 patients with histologically confirmed disease progression and ≥ 6 months after completion of front-line platinum-based chemotherapy. “At the time of the final [progression-free survival] analysis (338 events), the median follow-up was 24 months,” the authors reported. The median [progression-free survival] was 12.4 months for patients receiving bevacizumab vs 8.4 months for those receiving placebo (P < .0001).
“As ovarian cancer becomes a chronic illness, treatments that prolong [progression-free survival], and therefore time without cytotoxic chemotherapy, become increasingly relevant,” the authors noted.
Other Key Data
The overall response rate was also significantly improved in patients receiving bevacizumab—78.5% vs 57.4% in the placebo group (P < .0001). The duration of response was 10.4 months for patients receiving bevacizumab vs 7.4 months for patients receiving placebo.
The median overall survival data remain immature, but the most recent analysis put survival at 35.2 months among patients receiving placebo vs 33.3 months for those receiving bevacizumab. The majority of the 235 deaths (48.6% of patients) resulted from disease progression. ‘‘The [overall survival] data from OCEANS are not yet mature, and the percentage of patients receiving subsequent therapy with chemotherapy and with bevacizumab or other antiangiogenic therapy is being observed for subsequent analysis,” the researchers stated. “The National Comprehensive Cancer Network Compendium lists bevacizumab as a therapeutic option for [recurrent ovarian cancer], making subsequent therapy with bevacizumab an available choice for many women with [this disease] in the United States,” the authors added.
“All patients in both arms experienced at least one adverse event,” the researchers reported. Serious adverse events occurred in 34.8% of patients receiving bevacizumab and 24.9% of patients receiving placebo. Grade 3 or higher hypertension and proteinuria occurred more frequently in patients receiving bevacizumab. “The rates of neutropenia and febrile neutropenia were similar in both arms,” the authors wrote. No gastrointestinal perforations occurred during study treatment or within the 30-day safety-reporting period. ■
Disclosure: The Ovarian Cancer Study Comparing the Efficacy and Safety of Chemotherapy and Anti-Angiogenic Therapy in Platinum-Sensitive Recurrent Disease (OCEANS) study was sponsored by Genentech.
1. Aghajanian C, Blank SV, Goff BA, et al: OCEANS: A randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 30:2039-2045, 2012.