According to a new study published online in the journal The Lancet Oncology, researchers have found that overall survival with the combination of lenalidomide, docetaxel, and prednisone was significantly worse than with docetaxel plus prednisone for the treatment of chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC).
For the double-blind, placebo-controlled, phase III study, researchers enrolled 1,059 patients with chemotherapy-naive mCRPC and randomly assigned them to receive docetaxel 75mg/m2 on day 1 and prednisone 5mg twice daily on days 1-21 and either lenalidomide 25mg or placebo daily on days 1-14 of each 21 day cycle.
Results showed that after a median follow-up of 8 months, 129 patients in the lenalidomide group and 92 in the placebo group had died.
Median overall survival in the lenalidomide group was 17.7 months (95% CI: 14.8 – 18.8) and had not been reached in the placebo group (HR = 1.53; 95% CI: 1.17 – 2.00; P = 0.0017).
Because of the number of deaths in the lenalidomide group, the study was closed early; however, the number of deaths that occurred during treatment or less than 28 days after the last dose were similar in both groups.
- Petrylak DP, Vogelzang NJ, Budnik N, et al. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MANSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)70025-2.