title: 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.
  
  
  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.affiliation: Department of Medical Oncology, BC Cancer Agency, Vancouver Centre, Vancouver. Electronic address: kchi@bccancer.bc.ca.
authors.forename: K N
authors.initials: KN
authors.lastname: Chi
authors.affiliation: Department of Medical Oncology, BC Cancer Agency, Vancouver Centre, Vancouver.
authors.forename: E
authors.initials: E
authors.lastname: Beardsley
authors.affiliation: Department of Medical Oncology, Tom Baker Cancer Centre, Calgary.
authors.forename: B J
authors.initials: BJ
authors.lastname: Eigl
authors.affiliation: Department of Medical Oncology, Cross Cancer Institute, Edmonton.
authors.forename: P
authors.initials: P
authors.lastname: Venner
authors.affiliation: Department of Medical Oncology, Juravinski Cancer Centre, Hamilton.
authors.forename: S J
authors.initials: SJ
authors.lastname: Hotte
authors.affiliation: Department of Medical Oncology, London Health Sciences Centre, London.
authors.forename: E
authors.initials: E
authors.lastname: Winquist
authors.affiliation: Department of Medical Oncology, Sunnybrook Health Sciences Centre, Toronto.
authors.forename: Y-J
authors.initials: YJ
authors.lastname: Ko
authors.affiliation: Department of Medical Oncology, Princess Margaret Hospital, Toronto, Canada.
authors.forename: S S
authors.initials: SS
authors.lastname: Sridhar
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: D
authors.initials: D
authors.lastname: Weber
authors.affiliation: Department of Urology, University of Montreal, Montreal, Canada.
authors.forename: F
authors.initials: F
authors.lastname: Saad
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002170:Canada; D002369:Castration; D018572:Disease-Free Survival; D000077143:Docetaxel; D034261:Epothilones / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016879:Salvage Therapy / Q000379:methods*; D043823:Taxoids / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D034261:Epothilones; D043823:Taxoids; D000077143:Docetaxel; D017430:Prostate-Specific Antigen; C093788:epothilone B