The addition of Avastin® (bevacizumab) to standard chemotherapy significantly improved progression-free survival and objective response rate among women with platinum-resistant recurrent ovarian cancer, according to the results of a study published early online in the Journal of Clinical Oncology.
Each year in the United States, roughly 22,000 women are diagnosed with ovarian cancer and more than 15,000 die of the disease. Treatment for ovarian cancer commonly involves surgery and/or chemotherapy. Women who experience cancer progression during or within six months of treatment with a platinum-based chemotherapy regimen are considered to have platinum-resistant cancer. Researchers continue to study new approaches for treating platinum-resistant cancer.
Avastin is a targeted therapy that blocks a protein known as VEGF. VEGF plays a key role in the development of new blood vessels. By blocking VEGF, Avastin deprives the cancer of nutrients and oxygen and inhibits its growth.
The AURELIA Trial was a randomized phase III study that included 361 patients with epithelial ovarian, fallopian tube or primary peritoneal cancer—all of whom had disease progression within six months of their last dose of platinum therapy. Patients were randomly assigned to receive Avastin plus chemotherapy or chemotherapy alone. Chemotherapy consisted of one of three standard chemotherapy drugs typically offered in platinum-resistant cancer (paclitaxel, topotecan, or liposomal pegylated doxorubicin. Patients continued to receive therapy until progression, unacceptable toxicity, or consent withdrawal. Crossover to single-agent Avastin was permitted after progression with chemotherapy alone.
The primary endpoint was progression-free survival (PFS) by RECIST (response evaluation criteria in solid tumors). Secondary endpoints included objective response rate (ORR), overall survival (OS), safety, and patient-reported outcomes.
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Median follow-up was 13 months in the Avastin/chemotherapy group and 13.9 months in the chemotherapy-alone group. Median progression-free survival on RECIST criteria was 6.7 months in the Avastin/chemotherapy group and 3.4 months in the chemotherapy-alone group. The objective response rate on RECIST criteria was 27.3 percent in the Avastin/chemotherapy group and 11.8 percent in the chemotherapy-alone group.
At the time of data cutoff for the final overall survival analysis, 40 percent of patients in the chemotherapy-alone group had crossed over to receive single-agent Avastin after progression. Median overall survival was 16.6 months in the Avastin/chemotherapy group and 13.3 months in the chemotherapy-alone group and this was not considered a statistically significant difference.
Grade ? 2 hypertension and proteinuria were more common with Avastin. GI perforation occurred in 2.2 percent of Avastin-treated patients.
The researchers concluded that the addition of Avastin to standard chemotherapy significantly improved progression-free survival and objective response rates in women with platinum-resistant recurrent ovarian cancer.
Pujade-Lauraine E, Hilpert F, Weber B, et al: Bevacizumab Combined With Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer: The AURELIA Open-Label Randomized Phase III Trial. Journal of Clinical Oncology. Published early online March 17, 2014. doi: 10.1200/JCO.2013.51.4489