Clinical Cancer esearch cer Therapy : Clinical alidomide in Nonmetastatic Biochemically Relapsed state Cancer : Results of a Phase I / II R ble-Blinded , Randomized Study

Download pose: To evaluate the safety and activity of 6 months of treatment with lenalidomide at 5 or 25 mg/d metastatic biochemically relapsed prostate cancer. erimental Design: Sixty men with non-castrate, nonmetastatic, biochemically relapsed prostate were stratified by prostate-specific antigen (PSA) doubling time, surgery/radiation therapy, prior gen deprivation therapy (ADT), and randomized to lenalidomide 5 mg (n = 26) or 25 mg/d (n = 34) eeks repeated monthly for 6 months or until dose-limiting toxicity or disease progression. Toxicity aluated monthly, and PSAs and X-rays/scans every 6 months. Study size was determined to detect a ssion rate of 40% at 6 months in either arm with 85% power (compared with a rate of 80% in the ation receiving no treatment). Changes in PSA slopes were calculated using the regression of the log r each patient before and during the initial 6 months and compared by t test. ults: Baseline variables were balanced between arms. Grade 3/4 toxicity rates were 12% (n = 3) with and 29% (n = 10) with 25 mg (P = 0.1), most commonly neutropenia (five patients, all on 25 mg). atients per arm had thromboembolic events. The change in PSA slope was greater with 25 mg versus [−0.172 (−0.24 to −0.11) versus −0.033 (−0.11 to 0.04); P = 0.005]. With a mean follow-up of onths (range 14-44), five patients on 25 mg and one patient on 5 mg remain on the study. clusions: Lenalidomide has acceptable toxicity and is associated with long-term disease stabilizaCon tion and PSA declines. Randomized studies evaluating conventional clinical disease end points in this patient population are planned. Clin Cancer Res; 16(21); 5269–76. ©2010 AACR.