Chicago, IL—The addition of bevacizumab (Avastin) to standard chemotherapy extended survival in women with platinum-sensitive recurrent ovarian cancer compared with chemotherapy alone in the phase 3 randomized controlled GOG0213 trial. The results were presented at the 2015 Society of Gynecologic Oncology annual meeting.
The median overall survival was 42.2 months for women randomized to receive bevacizumab plus chemotherapy versus 37.2 months for those assigned to chemotherapy alone. Progression-free survival was improved by nearly 3.4 months with the addition of bevacizumab—13.8 months versus 10.4 months with chemotherapy alone.
Bevacizumab reduced the risk for death by 17% and the risk for progression by 39%.
“Most women whose ovarian cancer is recurring want every edge to extend their lives. This trial, while not completely definitive, builds on previous data, offering hope that we can hone in on treatments to achieve that goal,” said lead investigator Robert L. Coleman, MD, Vice Chair, Clinical Research, Department of Gynecologic Oncology and Reproductive Medicine, M.D. Anderson Cancer Center, Houston, TX.
Platinum-based doublets are a standard of care for women with platinum-sensitive recurrent ovarian cancer. The GOG0213 trial was designed to evaluate the role of the addition of bevacizumab to standard chemotherapy and the role of secondary cytoreductive surgery. At the meeting, the results of the first part of the study were presented.
The study randomized 374 women to standard chemotherapy with paclitaxel (Taxol) plus carboplatin (Paraplatin) and 374 women to standard chemotherapy plus bevacizumab. Both arms received 6 cycles of chemotherapy, and the study arm continued to receive bevacizumab maintenance therapy.
This is the first clinical trial of bevacizumab in the setting of ovarian cancer with overall survival being the primary end point.
Both treatment arms were well-balanced for demographic and disease characteristics. The patients’ median age was 60 years, and 81% of patients had serous histology.
Patients who received bevacizumab had significantly more grade ?3 adverse events, including gastrointestinal necrosis fistula (1% vs 1.8%, respectively; P = .05), infections (5.8% vs 13%, respectively; P = .002), joint pain (4.6% vs 15.1%, respectively; P <.001), and proteinuria (0% vs 8.1%, respectively; P <.001). However, these events were consistent with the known side effect profile of bevacizumab.
The ongoing study will assess quality of life of women in both arms of the trial, as well as the role of secondary cytoreductive surgery before receiving chemotherapy.
