OCEANS Study Results

SGO OCEANS Study Results: A Phase III, Multicenter, Randomized Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine plus Bevacizumab in Patients with Platinum- sensitive Recurrent Ovary, Primary Peritoneal or Fallopian Tube Carcinoma

June 2011

Results of a placebo controlled, randomized Phase III clinical trial involving the addition of bevacizumab to platinum based chemotherapy in women with platinum sensitive ovarian, primary peritoneal or fallopian tube cancer at the time of first recurrence have recently been reported at the American Society of Clinical Oncology’s Annual Meeting. There were two treatment arms in the trial known as “OCEANS”. These included 1) intravenous carboplatin and gemcitabine with placebo followed by placebo until progression and 2) intravenous carboplatin and gemcitabine in conjunction with bevacizumab followed by bevacizumab until progression or toxicity. An important qualifier for study participation was that patients could not have received bevacizumab as part of their initial cancer treatment.

The trial Investigators found a four month improvement in median progression free survival (PFS) when bevacizumab was added to carboplatin and gemcitabine chemotherapy and continued as a single agent. PFS was 12.4 months for the experimental arm and 8.4 months for the chemotherapy arm without bevacizumab. The Hazard Ratio for the experimental arm compared to control was 0.484 which represents a 52 percent reduction in the risk of progression compared to the control arm. These results measure favorably when compared to other trials in platinum sensitive recurrent ovarian cancer. In addition, the toxicity profile of bevacizumab in combination with chemotherapy was similar to what has been previously described, and no new toxicities were reported. Bowel perforation was not observed in patients on trial.

The authors report that it is too early to determine how this approach will impact long- term patient survival. Of note, there was no quality of life data collected.

The results of this study have been featured in various professional and consumer media outlets, causing physicians and patients to seek guidance regarding the implications from this trial. The Society of Gynecologic Oncology (SGO) encourages patients and providers to discuss risks, benefits and costs associated with use of bevacizumab as a component of treatment for recurrent ovarian, primary peritoneal or fallopian tube cancers. SGO also commends the investigators and the many patients who participated in this study for contributing valuable data that advance the evidence- based management of these diseases.