Addition of Bevacizumab to Chemotherapy Extends Survival in Women With Platinum-Sensitive Recurrent Ovarian Cancer
In a phase III study of women with ovarian cancer, researchers found that the addition of bevacizumab (Avastin) to standard chemotherapy extended median overall survival by 5 months compared to standard chemotherapy alone. The bevacizumab combination was also associated with a significant improvement in progression-free survival. The findings were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in Chicago (Abstract 4917).
Study Findings
The preliminary findings of the phase III, randomized, controlled trial included women with platinum-sensitive recurrent ovarian cancer. A total of 374 women received the standard chemotherapy treatment of paclitaxel and carboplatin. Another 374 received the chemotherapy drugs paclitaxel and carboplatin, plus bevacizumab. Both arms received paclitaxel and carboplatin for six cycles, and the study arm patients continued with bevacizumab maintenance. Unlike previous ovarian clinical trials of bevacizumab, this study’s primary endpoint was overall survival.
Median overall survival for woman in the chemotherapy-plus-bevacizumab arm was 42.2 months, compared with 37.3 for those receiving chemotherapy alone. The period of time before disease progression was significantly improved, with patients in the chemotherapy-plus-bevacizumab arm having a median progression-free survival of 13.8 months vs 10.4 months in the chemotherapy-alone arm. The risk reduction for progression and death were 39% (P < .0001) and 17% (P = .056), respectively.
“Most women whose ovarian cancer is recurring want every edge to extend their lives,” said lead author Robert L. Coleman, MD, of The University of Texas MD Anderson Cancer Center. “This trial, while not completely definitive, builds on previous data, offering hope that we can hone in on treatments to achieve that goal.”
Side Effects
Some expected side effects, including gastrointestinal damage and joint pain, were observed, but none that suggested a significant safety concern. The ongoing study will assess quality of life for women receiving the additional drug and the role of secondary surgery before chemotherapy.
This study, conducted by the Gynecologic Oncology Group, was the second to test bevacizumab under these conditions (first chemotherapy for platinum-sensitive recurrence), a use for which bevacizumab is not currently approved by the U.S. Food and Drug Administration (FDA). Both this trial, also known as GOG0213, and the previous trial, known as OCEANS, showed a longer delay in time to the next recurrence when bevacizumab is added to standard chemotherapy. Neither study showed a significant improvement in long-term survival, though GOG0213 reported a strong trend toward improved overall survival. In 2014, the FDA approved bevacizumab with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
