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OCEANS: Addition of bevacizumab to chemotherapy increased PFS in ovarian cancers
The addition of bevacizumab to gemcitabine and carboplatin, and continuing treatment with bevacizumab until disease progression, significantly improved PFS compared with gemcitabine and carboplatin alone in patients with platinum-sensitive recurrent ovarian, primary peritoneal or fallopian tube cancers.
These results are the third positive phase 3 trial results that indicate that adding bevacizumab (Avastin, Genentech) to chemotherapy improved outcomes in ovarian cancer.
The randomized, phase 3, placebo-controlled OCEANS trials evaluated 484 women with platinum sensitive recurrent ovarian, primary peritoneal or fallopian tube cancer (ROC). All patients were aged at least 18 years and had disease progression after 6 months or longer of front-line platinum-based chemotherapy. Patients were randomly assigned to treatment with gemcitabine and carboplatin with or without bevacizumab for six to 10 cycles.
Final PFS analysis took place with a median follow-up of 24 months. At that time, those patients assigned to bevacizumab had a significantly longer PFS compared with patients assigned to placebo (HR=0.484; 95% CI, 0.388-0.605). Median PFS was 12.4 months for bevacizumab vs. 8.4 months for placebo.
Patients assigned to bevacizumab also had a significantly improved overall response rate compared with those assigned to placebo. Response was 78.5% in the bevacizumab arm vs. 57.4% in the placebo arm. The majority of responses in both arms were partial. Duration of response was an average of 10.4 months for bevacizumab vs. 7.4 months for placebo.
All patients experienced at least one adverse event, with serious events occurring in 24.9% of the placebo arm and 34.8% of the bevacizumab arm. Two patients receiving bevacizumab had gastrointestinal perforation after treatment discontinuation.
“As ovarian cancer becomes a chronic illness, treatments that prolong PFS, and therefore time without cytotoxic chemotherapy, become increasingly relevant,” the researchers wrote.
Perspective
Back to TopThe OCEANS trial is an important study, as it demonstrates the favorable impact of combining bevacizumab with standard chemotherapy on both the opportunity for a patient to achieve a meaningful objective response and also delay the time to subsequent progression of the disease process. It is not at all surprising that this treatment regimen was unable to be documented to improve OS, as it is now very well-established and accepted by the oncology community that, following disease progression on such trials in ovarian cancer, patients will receive a number of biologically and clinically active agents — including the “experimental drug” — that will favorably impact the survival outcome for those individuals on the control arm.
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