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

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

Received: 1 August 2011; in revised form: 26 August 2011 / Accepted: 29 August 2011 / Published: 2 September 2011
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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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MDPI and ACS Style

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.

AMA Style

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.

Chicago/Turabian Style

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.

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