Monoclonal antibody increases cervical cancer survival

Adding a monoclonal antibody (MAb)-bevacizumab-to combination chemotherapy may increase survival in patients with recurrent cervical cancer, according to results of a National Cancer Institute-funded randomized trial. Use of bevacizumab in cervical cancer is experimental; the MAb currently is approved to treat metastatic colorectal cancer, non-squamous, non-small cell lung cancer, and glioblastoma.

Published in the New England Journal of Medicine, the study evaluated the effectiveness of bevacizumab and nonplatinum combination chemotherapy in 452 patients with recurrent, persistent, or metastatic cervical cancer.  Chemotherapy consisted of cisplatin (50 mg/m²) plus paclitaxel (135 or 175 mg/m²) or topotecan (0.75 mg/m²) on days 1 to 3, plus paclitaxel (175 mg/m²) on day 1. The bevacizumab dosage was 15 mg/kg of body weight. Randomization was to treatment with and without the addition of the MAb and cycles were repeated every 21 days until disease progressed, patients developed unacceptable toxic effects, or a complete response was documented.

Overall survival was the primary endpoint and a 30% reduction in the hazard ratio for death was considered clinically important. In patients who received chemotherapy plus bevacizumab, overall survival was 17.0 months versus 13.3 months in those who received chemotherapy alone (hazard ratio for death 0.71; 98% confidence interval, 0.54 to 0.95; P=0.004). Response rates also were higher with the MAb (48% vs 36%; P=0.008). Bevacizumab was associated with increased incidence of hypertension of grade 2 or higher (25% vs 2%) thromboembolic events of grade 3 or higher (8% vs 1%) and gastrointestinal fistulas of grade 3 or higher (3% vs 0%).

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