Lenalidomide monotherapy in chemotherapy-naive, castration-resistant prostate cancer patients: Final results of a phase II study - 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: Patients received 25 mg/d lenalidomide for 21 days in 28-day cycles, until disease progression or unacceptable toxicity developed. Endpoints included overall response rate and clinical benefit (overall response + stable disease), toxicity, time to radiographic progression, and time to prostate-specific antigen (PSA) progression, overall survival, and quality of life.

RESULTS: Thirty-two patients were enrolled in the study; of these, 77% (n = 25) had Gleason scores ≥ 7. The median age was 74 years (58-89 y), the median PSA level was 66 ng/mL (2-919 ng/mL), and 5 of 32 patients (17%) had liver or lung involvement. The median number of lenalidomide cycles was 3 (1-16 cycles). Stable disease was seen in 20 patients, for a clinical benefit rate of 63%. The median time to radiographic progression was 4 months (2-16 mo); the median overall survival was 20 months. Of 27 PSA-evaluable patients, 13 (48%) had a decline in PSA level; 3 (11%) had > 50% PSA decrease; the median time to PSA progression was 3 months (2-9 mo). Grade 3/4 hematologic toxicities were the most common adverse events without adverse impact on quality of life. Serious adverse events occurred in 14 patients (44%), including 1 patient (3%) with a rash definitely related to lenalidomide.

CONCLUSION: Lenalidomide monotherapy demonstrates modest activity in chemotherapy-naive CRPC.

Written by:
Nabhan C, Patel A, Villines D, Tolzien K, Kelby SK, Lestingi TM.   Are you the author?
Department of Medicine, Section of Hematology and Oncology, The University of Chicago, Chicago, IL.

Reference: Clin Genitourin Cancer. 2013 Oct 1. pii: S1558-7673(13)00212-7.
doi: 10.1016/j.clgc.2013.09.001


PubMed Abstract
PMID: 24238760

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