FDA Approves Bevacizumab Plus Chemotherapy for Platinum-Resistant, Recurrent Ovarian Cancer

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The U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The approval is based on the results of an international, randomized, two-arm trial (AURELIA) with the primary comparison of investigator-assessed progression-free survival. This trial compared bevacizumab plus chemotherapy vs chemotherapy alone. The trial enrolled 361 patients: 179 patients were assigned to receive bevacizumab plus chemotherapy, and 182 patients were assigned to receive chemotherapy alone. The chemotherapy included paclitaxel, pegylated liposomal doxorubicin, or topotecan.

Treatment continued until disease progression, unacceptable toxicity, and/or consent withdrawal. All enrolled patients had received no more than two prior chemotherapy regimens, had an ECOG performance status of 0 to 2, and had recurred within less than 6 months from the most recent platinum-based therapy.

The progression-free survival assessment demonstrated a statistically significant improvement in patients who received bevacizumab plus chemotherapy compared to those who received chemotherapy alone (hazard ratio [HR] = 0.38, 95% confidence interval [CI] = 0.30–0.49, P < .0001, stratified log-rank test). The median progression-free survival of patients who received bevacizumab plus chemotherapy was 6.8 months (95% CI = 5.6–7.8) compared to 3.4 months (95% CI = 2.1–3.8) for those receiving chemotherapy alone. There was no significant difference in overall survival (16.6 vs 13.3 months; HR = 0.89, 95% CI = 0.69–1.14).

Exploratory Analyses

The trial was stratified by chemotherapy regimen. Exploratory analyses were performed by comparing the addition of bevacizumab to each chemotherapy regimen.

The addition of bevacizumab to paclitaxel provided the largest improvement, resulting in a 5.7-month improvement in median progression-free survival (9.6 vs 3.9 months; HR = 0.47, 95% CI = 0.31–0.72), an improvement in the overall response rate of 23% (53% vs 30%), and a 9.2-month improvement in median overall survival (22.4 vs 13.2 months; HR = 0.64, 95% CI = 0.41–1.01).

Ninety-seven per cent of patients in the paclitaxel regimen had received paclitaxel with previous chemotherapy regimens. These exploratory analyses suggest that patients who have received prior treatment with paclitaxel may benefit from bevacizumab plus weekly paclitaxel. ■





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