The preliminary findings were reported here at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
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 treatment was 42.2 months, compared with 37.3 for those receiving chemotherapy alone. The period of time before ovarian cancer recurred (called progression-free survival) improved by nearly 3.5 months with the additional drug (13.8 months compared with 10.4 months for the woman on chemotherapy alone). The risk reduction for progression and death were 39% and 17%, 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 in Houston. “This trial, while not completely definitive, builds on previous data, offering hope that we can hone in on treatments to achieve that goal.”
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, a cooperative group funded by the National Cancer Institute, 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 Food and Drug Administration. Both this trial, also known as GOG 213, and the previous trial, known as OCEANS and published June 10, 2012, in the Journal of Clinical Oncology, 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 GOG 213 reported a strong trend towards improved overall survival. In 2014, the FDA approved bevacizumab with chemotherapies for the treatment of women with platinum-resistant, recurrent ovarian cancer.