A phase 2 study of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Canadian Urologic Oncology Group study P07a.

Abstract

BACKGROUND:

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.

PATIENTS AND METHODS:

Eligible patients had progressive disease within 6 months of receiving docetaxel. Patupilone was administered 10 mg/m2 i.v. every 3 weeks. The primary end point was the proportion of patients with a confirmed≥50% prostate-specific antigen (PSA) decline.

RESULTS:

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/m2 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).

CONCLUSIONS:

Patupilone at 8 mg/m2 was tolerable, had antitumor activity, and was associated with symptomatic improvement in patients previously treated with docetaxel.

• Authors: K N Chi, E Beardsley, B J Eigl, P Venner, S J Hotte, E Winquist, Y-J Ko, S S Sridhar, D Weber, F Saad
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 23 Issue 1 Pg. 53-58 (Jan 2012) ISSN: 1569-8041 [Electronic] England
• PMID: 21765178 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Epothilones
• Taxoids
• Docetaxel
• Prostate-Specific Antigen
• epothilone B

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Agents (therapeutic use)
• Canada
• Castration
• Disease-Free Survival
• Docetaxel
• Epothilones (therapeutic use)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Prostate-Specific Antigen (blood)
• Prostatic Neoplasms (drug therapy, mortality)
• Salvage Therapy (methods)
• Taxoids (therapeutic use)