Lenalidomide monotherapy in chemotherapy-naive, castration-resistant prostate cancer patients: final results of a phase II study.

摘要: Abstract Background We investigated the activity of lenalidomide, which has antiangiogenic, antineoplastic, and immunomodulatory properties, in chemotherapy-naive, castration-resistant prostate cancer (CRPC) patients. Patients received 25 mg/d lenalidomide for 21 days 28-day cycles, until disease progression or unacceptable toxicity developed. Endpoints included overall response rate clinical benefit (overall response + stable disease), toxicity, time to radiographic progression, prostate-specific antigen (PSA) survival, quality life. Results Thirty-two patients were enrolled study; these, 77% (n = 25) had Gleason scores ≥ 7. The median age was 74 years (58-89 y), PSA level 66 ng/mL (2-919 ng/mL), 5 32 (17%) liver lung involvement. number cycles 3 (1-16 cycles). Stable seen 20 patients, a 63%. 4 months (2-16 mo); survival months. Of 27 PSA-evaluable 13 (48%) decline level; (11%) > 50% decrease; (2-9 mo). Grade 3/4 hematologic toxicities most common adverse events without impact on Serious occurred 14 patients (44%), including 1 patient (3%) with rash definitely related lenalidomide. Conclusion Lenalidomide monotherapy demonstrates modest chemotherapy-naive CRPC.