The use of the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (Avastin) improved progression-free survival in women with ovarian cancer, with the greatest benefits in both progression-free and overall survival seen among patients at high risk for disease progression.
In a multinational trial that begin in 2006 and will continue through 2013, 1,528 women with ovarian cancer (median age 57 years) throughout 11 countries were randomly assigned to receive one of two regimens:
- carboplatin and paclitaxel given every 3 weeks for six cycles (standard therapy)
- standard therapy plus bevacizumab, given concurrently every 3 weeks for five or six cycles and continued for 12 additional cycles or until progression of disease.
Most of the women (90%) had epithelial ovarian cancer, 69% had a serous histologic type, 9% had high-risk early-stage disease, 30% were at high risk for progression, and 70% had stage IIIC or IV ovarian cancer.
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At the 36-month mark of the 7-year study, progression-free survival (restricted mean) was 20.3 months with standard therapy and 21.8 months for standard therapy plus bevacizumab. At 42 months, restricted mean progression-free survival rose to 22.4 months without bevacizumab and 24.1 months with bevacizumab.
Among the women who were at high risk for progression, treatment benefit was greater with bevacizumab than without at 42 months, with a restricted mean progression-free survival of 18.1 months vs 14.5 months. Median overall survival was 36.6 months with bevacizumab and 28.8 months without (N Engl J Med. 2011;365:2484-2496).
Bevacizumab was associated with more toxic effects (most often hypertension of grade 2 or higher), 18% vs 2% with chemotherapy alone. In November 2011, the FDA revoked the accelerated approval of bevacizumab for metastatic breast cancer after ruling that the drug had not been shown to provide a benefit in terms of delay in the growth of tumors, overall survival, or quality of life that would justify its serious risks. The antiangiogenic agent remains on the market in other countries as a treatment for metastatic breast cancer and in the United States for certain types of colon, lung, kidney, and brain cancers.
Corrected January 13, 2012.
