(HealthDay) -- For men with metastatic castration-resistant prostate cancer (mCRPC), the addition of bevacizumab (B) to docetaxel plus prednisone (DP) is not associated with improved overall survival (OS), but does improve progression-free survival (PFS) and objective response (OR), according to a study published online March 26 in the Journal of Clinical Oncology.
To evaluate the efficacy of DP treatment with and without B, William Kevin Kelly, D.O., of Thomas Jefferson University in Philadelphia, and colleagues conducted a phase 3, randomized, placebo-controlled trial involving 1,050 men with chemotherapy-naive progressive mCRPC. OS was the primary end point, and secondary end points included PFS, OR, and toxicity.
The researchers observed no significant difference in median OS between patients receiving DP+B and DP (22.6 and 21.5 months, respectively; stratified log-rank P = 0.181). Men treated with DP+B had significantly longer median PFS compared with those receiving DP alone (9.9 versus 7.5 months; stratified log-rank P < 0.001). The proportion of patients with OR was significantly superior in the DP+B group versus DP alone (49.4 versus 35.5 percent; P = 0.0013). Treatment-related deaths (4.0 versus 1.2 percent; P = 0.005) and the percentage of men experiencing grade 3 or higher treatment-related toxicity (75.4 versus 56.2 percent; P ≤ 0.001) were significantly higher for those receiving DP+B.
"Despite an improvement in PFS and OR, the addition of bevacizumab to docetaxel and prednisone did not improve OS in men with mCRPC and was associated with greater toxicity," the authors write.
The authors disclosed financial relationships with pharmaceutical companies, including Genentech, which together with Roche funded the study.
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