Addition of Aflibercept to Docetaxel/Prednisone Does Not Improve Overall Survival in Men with Metastatic Castration-resistant Prostate Cancer
In a phase III double-blind study (VENICE trial) reported in Lancet Oncology, Ian F. Tannock, DSc, of Princess Margaret Cancer Centre in Toronto, and colleagues evaluated the addition of the antiangiogenic agent aflibercept (Zaltrap) to standard docetaxel/prednisone therapy in patients with metastatic castration-resistant prostate cancer. Median overall survival was not improved with the addition of aflibercept.
Study Details
In this international trial, 1,224 men with metastatic castrate-resistant prostate cancer, adequate organ function, and no prior chemotherapy were randomly assigned to receive docetaxel (75 mg/m2 every 3 weeks) and oral prednisone (5 mg twice daily) with (n = 612) or without (n = 612) aflibercept (6 mg/kg) or placebo every 3 weeks. The primary endpoint was overall survival.
Overall Survival and Safety Outcomes
At final analysis, the median follow-up was 35 months. Median overall survival was 22.1 months in the aflibercept group and 21.2 months in the placebo group (stratified hazard ratio = 0.94, P = .38).
Aflibercept treatment was associated with a greater frequency of grade 3 or 4 gastrointestinal disorders (30% vs 8%), hemorrhagic events (5.2% vs 1.7%), hypertension (13% vs 3.3%), fatigue (16% vs 7.7%), and infections (20% vs 10%), as well as a greater frequency of treatment-related fatal adverse events (3.4% vs 1.5%).
The investigators concluded, “Aflibercept in combination with docetaxel and prednisone given as first-line chemotherapy for men with metastatic castrate-resistant prostate cancer resulted in no improvement in overall survival and added toxicity compared with placebo. Docetaxel plus prednisone remains the standard treatment for such men who need first-line chemotherapy.”
The study was funded by Sanofi and Regeneron Pharmaceuticals Inc.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
