Urology Medical News about romidepsin, castration-resistant prostate cancer, CRPC

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Phase II, two-stage, single-arm trial of the histone deacetylase inhibitor (HDACi) romidepsin in metastatic castration-resistant prostate cancer (CRPC)
Annals of Oncology, 07/29/09

Molife LR et al. - In a study to assess the use of romidepsin in pts with progressing, metastatic, castration-resistant prostate cancer (CRPC), it was concluded that romidepsin demonstrated minimal antitumor activity in chemonaive pts with CRPC.

Methods

A dose of 13 mg/m2 was administered i.v. over 4 h on days 1, 8 and 15 every 28 days.
Primary endpoint was rate of disease control defined as no evidence of radiological progression at 6 mos.
16 assessable pts in stage 1 and 9 assessable pts in stage 2 were selected; progression to stage 2 required 1 or more pts with disease control in stage 1.

Results

35 pts were enrolled.
2 pts achieved a confirmed radiological partial response (RECIST) lasting 6 mos, along with a confirmed prostate-specific antigen decline of 50%.
11 pts experienced toxicity necessitating early discontinuation.
Most common adverse events were nausea (30 pts; 85.7%), fatigue (28 pts; 80.0%), vomiting (23 pts; 65.7%) and anorexia (20 pts; 57.1%).
There was no significant cardiac toxicity.

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