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Cancers 2011, 3(3), 3449-3460; doi:10.3390/cancers3033449
Article

Phase II Study of Pomalidomide in Patients with Castration-Resistant Prostate Cancer

1,* , 2,3
,
1, 4
 and
2.3
1 Memorial Hermann Cancer Center, University of Texas, 6410 Fannin Street, Suite 830, Houston, TX 77030, USA 2 Health Science Center, University of Colorado, Denver, CO 80217, USA 3 University of Colorado Cancer Center, Aurora, CO 80045, USA 4 Celgene Corporation, Summit, NJ 07901-3915, USA
* Author to whom correspondence should be addressed.
Received: 1 August 2011 / Revised: 26 August 2011 / Accepted: 29 August 2011 / Published: 2 September 2011
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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 prostate cancer; metastatic; castration-resistant; pomalidomide; thalidomide analog; antiangiogenic; immunomodulatory
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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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.

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