GOG 218 Phase III Trial Study Results

GOG 218 Phase III Trial Study Results

June 2010

Results of a placebo controlled randomized Phase III clinical trial involving the addition of bevacizumab to standard chemotherapy treatment in women with newly diagnosed, advanced ovarian, primary peritoneal or fallopian tube cancer have recently been reported at the annual meeting of the American Society of Clinical Oncology. Three treatment arms were included in the trial known as GOG 218. These included 1) standard intravenous paclitaxel and carboplatin 2) intravenous paclitaxel and carboplatin in conjunction with bevacizumab and 3) intravenous paclitaxel, carboplatin and bevacizumab with continuation of bevacizumab as a single agent for an additional 10 months (maintenance).

The Society of Gynecologic Oncology commends the Gynecologic Oncology Group, their investigators and the many patients who participated in this study for contributing valuable data advancing the evidence-based management of these diseases.

The main finding was a significant improvement in progression free survival (PFS) with the addition of bevacizumab to upfront intravenous chemotherapy when the bevacizumab was continued as a maintenance regimen after chemotherapy. This improvement in PFS was 3.8 months (10.3 for standard chemotherapy, 14.1 months for the maintenance regimen). The authors report that it is too early to determine how this approach will impact long-term patient survival.

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. SGO encourages patients and providers to discuss risks, benefits and costs associated with use of bevacizumab as a component of upfront treatment and maintenance therapy.