Department of Medical Oncology, BC Cancer Agency, Vancouver Centre, Vancouver.
The purpose of this study was to determine the clinical activity of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel.
Eligible patients had progressive disease within 6 months of receiving docetaxel. Patupilone was administered 10 mg/m(2) i.v. every 3 weeks. The primary end point was the proportion of patients with a confirmed ≥50% prostate-specific antigen (PSA) decline.
Eighty-three patients were enrolled. At baseline, the median time to progression after prior docetaxel was 1.4 months (range 0-5.7). Gastrointestinal serious adverse events occurred in four of the six initial patients leading to a reduction of the starting dose of patupilone to 8 mg/m(2) for subsequent patients. Grade 3-4 toxicity at this dose included diarrhea (22%), fatigue (21%), and anorexia (10%). One patient experienced grade 3-4 hematologic toxicity. A PSA decline of ≥50% occurred in 47% of patients. A partial measurable disease response occurred in 24% of assessable patients. A patient-reported pain response was observed in 59% of assessable patients. Median time to PSA progression was 6.1 months [95% confidence interval (CI) 4.7-8.0] and median overall survival was 11.3 months (95% CI 9.8-15.4).
Patupilone at 8 mg/m(2) was tolerable, had antitumor activity, and was associated with symptomatic improvement in patients previously treated with docetaxel.
Chi KN, Beardsley E, Eigl BJ, Venner P, Hotte SJ, Winquist E, Ko YJ, Sridhar SS, Weber D, Saad F. Are you the author?
Reference: Ann Oncol. 2011 Jul 16. Epub ahead of print.