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Phase II Study of Pomalidomide in Patients with Castration-Resistant Prostate Cancer
Memorial Hermann Cancer Center, University of Texas, 6410 Fannin Street, Suite 830, Houston, TX 77030, USA
Health Science Center, University of Colorado, Denver, CO 80217, USA
University of Colorado Cancer Center, Aurora, CO 80045, USA
Celgene Corporation, Summit, NJ 07901-3915, USA
* Author to whom correspondence should be addressed.
Received: 1 August 2011; in revised form: 26 August 2011 / Accepted: 29 August 2011 / Published: 2 September 2011
Abstract: Background: Pomalidomide is a distinct immunomodulatory agent that also displays anti-proliferative and proapoptotic activity. The purpose of this study was to assess the efficacy and safety of pomalidomide for the treatment of chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). Methods: Pomalidomide was administered orally in doses of 1 or 2 mg/day without interruption. Follow ups were conducted every 4 weeks with evaluation of study outcomes at 12 weeks. The principal study outcomes were PSA response, time to progression (TTP) using RECIST, overall survival (OS), and safety. A total of 32 patients were enrolled: 15 in the 1 mg/day cohort (median baseline PSA level of 12.30 ng/mL [0.8–236.0]), and 17 in the 2 mg/day cohort (median baseline PSA level of 12.50 ng/mL [0.6–191.8]). Results: In the 1 mg cohort disease was stabilized for ≥28 days in eight patients, and median TTP was 2.90 months. In the 2 mg cohort, PSA decreased >50% in three patients, disease was stabilized for ≥28 days in seven patients, and median TTP was 5.87 months. Toxicity in both cohorts was predominantly grade 1 or 2; 2 grade 3 toxicity (fatigue) occurred in the 1 mg cohort, and 5 grade 3 toxicities (chest pain, diarrhea, epigastric pain, impaction, pain) occurred in the 2 mg cohort. One grade 4 toxicity of cardiac ischemia occurred. Conclusions: Pomalidomide shows promising activity in patients with CRPC and has an acceptable safety profile.
Keywords: prostate cancer; metastatic; castration-resistant; pomalidomide; thalidomide analog; antiangiogenic; immunomodulatory
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Amato, R.J.; Glode, L.M.; Podolnick, J.; Knight, R.; Crawford, D. Phase II Study of Pomalidomide in Patients with Castration-Resistant Prostate Cancer. Cancers 2011, 3, 3449-3460.
Amato RJ, Glode LM, Podolnick J, Knight R, Crawford D. Phase II Study of Pomalidomide in Patients with Castration-Resistant Prostate Cancer. Cancers. 2011; 3(3):3449-3460.
Amato, Robert J.; Glode, L. Michael; Podolnick, Jeremy; Knight, Robert; Crawford, David. 2011. "Phase II Study of Pomalidomide in Patients with Castration-Resistant Prostate Cancer." Cancers 3, no. 3: 3449-3460.