Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial

摘要: Summary Background Patients with metastatic castration-resistant prostate cancer have few treatment options. We investigated the safety and efficacy of lenalidomide, an immunomodulatory agent anti-angiogenic properties, in combination docetaxel prednisone chemotherapy-naive patients cancer. Methods In this randomised, double-blind, placebo-controlled, phase 3 study, we randomly assigned progressive a 1:1 ratio to receive (75 mg/m 2 ) on day 1 (5 mg twice daily) days 1–21 either lenalidomide (25 mg) or placebo once daily 1–14 each 21 cycle. Permuted block randomisation was done interactive voice response system stratified by Eastern Cooperative Oncology Group performance status, geographic region, type disease progression. Clinicians, patients, investigators were masked allocation. The primary endpoint overall survival. Efficacy analysis intention treat. who received at least one dose study drug included analyses. This is registered ClinicalTrials.gov, number NCT00988208. Findings 1059 enrolled between Nov 11, 2009, 23, 2011 (533 group 526 control group), 1046 (525 521 group). At data cutoff (Jan 13, 2012) after median follow-up 8 months (IQR 5–12), 221 had died: 129 92 group. Median survival 17·7 (95% CI 14·8–18·8) not reached (hazard [HR] 1·53, 95% 1·17–2·00, p=0·0017). trial subsequently closed early due futility. deaths that occurred during less than 28 since last similar both groups (18 [3%] 525 vs 13 [2%] patients). 109 (21%) 78 (15%) died more from dose, mainly grade higher adverse event reported 381 (73%) receiving 303 (58%) placebo. Grade 3–4 neutropenia (114 [22%] for 85 [16%] placebo), febrile (62 [12%] 23 [4%]), diarrhoea (37 [7%] 12 [2%]), pneumonia (24 [5%] five [1%]), dyspnoea (22 [4%] nine asthenia (27 17 [3%]), pulmonary embolism (32 [6%] seven [1%]) frequently Interpretation Overall docetaxel, significantly worse men metastatic, Further research warranted. Funding Celgene Corporation.