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OCEANS: Frontline bevacizumab extended PFS in recurrent ovarian cancer
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2011 ASCO Annual Meeting
CHICAGO — The addition of bevacizumab to gemcitabine/carboplatin chemotherapy cut the risk for disease progression by more than half in women with recurrent epithelial ovarian, primary peritoneal and fallopian tube cancers, according to phase-3 results from the OCEANS trial.
Bevacizumab (Avastin, Genentech) was associated with a 4-month extension of PFS compared with chemotherapy alone, and 78.5% of women in the experimental group experienced tumor shrinkage compared with just 57.4% of the women in the control group. Duration of response was also superior for the patients in the bevacizumab group: 10.4 months vs. 7.4 months (HR=0.534; 0.498-0.698).
“This study shows that bevacizumab in addition to a standard chemotherapy choice of carboplatin and gemcitabine followed by bevacizumab until progression of disease provides a clinically meaningful benefit in recurrent ovarian cancer,” said Carol Aghajanian, MD, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center. “There was a 52% reduction in the risk for progression with a median increase from 8.4 months to 12.4 months.”
Women with recurrent, platinum-sensitive disease who had undergone one prior round of chemotherapy were assigned to gemcitabine/carboplatin/placebo (n=242) or gemcitabine/carboplatin/bevacizumab (n=242). Bevacizumab or placebo was continued after the completion of chemotherapy until the time of disease progression.
Median age in the placebo group was 61 and 60 in the experimental group. Approximately one-third of patients were 65 or older in both groups.
After a median follow-up of 24 months, median PFS was 12.4 months in the bevacizumab group compared with 8.4 months for chemotherapy alone (HR=0.484; 95% CI, 0.388-0.605).
The rate of hypertension and proteinuria were higher in the experimental arm, but neutropenia and febrile neutropenia were identical. Researchers observed no gastrointestinal perforations.
“The safety data were reassuring and consistent with the known bevacizumab side effect profile,” Aghajanian said. – by Jason Harris
For more information:
- Aghajanian C. #LBA5007. Presented at: the 2011 ASCO Annual Meeting.
Disclosure: Dr. Aghajanian reported no relevant financial disclosures.
In advanced ovarian cancer, similar to advanced breast cancer, there is often the opportunity to intervene with many lines of chemotherapy. There are many chapters in the story, so to speak. The ability to prolong each and every chapter in this disease will, in my estimation, make the story longer. That is, ultimately improve survival. These trial results are certainly an important step in this direction with the 52% prolongation in time to progression patients can live with more time to lead full and active lives in the absence of chemotherapy. It’s also comforting to see that there were no new safety signals in this trial.
- Andrew Seidman, MD
Attending Physician in
the Breast Cancer Medicine Service,
Memorial Sloan-Kettering Cancer Center
Disclosure: Dr. Seidman reported serving in a consultant or advisory role for Enzon and Wyeth, receiving honoraria from Abraxis BioScience, Genentech and Genomic Health; and receiving research funding from Abraxis BioScience.
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