title: Phase II trial of cisplatin plus prednisone in docetaxel-refractory castration-resistant prostate cancer patients.
abstract: BACKGROUND
  Docetaxel represents the first-line treatment for castration-resistant prostate cancer (CRPC). New therapeutic options are needed for subsequent lines of therapy in CRPC patients.
  
  
  METHODS
  Patients with progressive CRPC, pretreated with docetaxel, were enrolled at the Department of Molecular and Clinical Oncology and Endocrinology of University 'Federico II of Naples' from April 2007 to January 2010. Accrued patients received cisplatin at the dose of 75 mg/m(2) every 3 weeks with daily 10 mg prednisone. Measures of response and progression were defined according to the Prostate Cancer Working Group (PCWG1) criteria. Toxicity was graded according to the Common Toxicity Criteria of the National Cancer Institute, version 3.0.
  
  
  RESULTS
  Twenty-five patients were recruited. Median age was 65 years (interquartile range 55-74 years). All patients were evaluable for PSA response and toxicity and thirteen patients (52%) were evaluable for measurable disease. A total of 170 cycles of cisplatin chemotherapy were administered. Median dose intensity corresponded to 96% (range 83.8-98.3%) of the maximum dose intensity that could be delivered. Three patients (12%) presented grade 3-4 neuropathy and ten (40%) presented grade 3-4 neutropenia. Five patients (20%) showed a greater than 50% PSA decline, and three of thirteen patients with measurable disease presented a partial response. Median progression-free survival was 5.6 months (24 weeks; range 15-24). Median survival was 55 weeks (range 46-64; see Fig. 1).
  
  
  CONCLUSIONS
  Cisplatin plus prednisone appears to represent an active regimen in docetaxel-refractory CRPC with an acceptable toxicity profile. Further investigations in this setting are warranted to confirm these early encouraging findings.
authors.affiliation: Department of Endocrinology and Medical Oncology, Genitourinary Cancer Section, University Federico II, Naples, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Buonerba
authors.forename: Piera
authors.initials: P
authors.lastname: Federico
authors.forename: Carmine
authors.initials: C
authors.lastname: D'Aniello
authors.forename: Pasquale
authors.initials: P
authors.lastname: Rescigno
authors.forename: Carla
authors.initials: C
authors.lastname: Cavaliere
authors.forename: Livio
authors.initials: L
authors.lastname: Puglia
authors.forename: Matteo
authors.initials: M
authors.lastname: Ferro
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Altieri
authors.forename: Sisto
authors.initials: S
authors.lastname: Perdonà
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D002369:Castration; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D011241:Prednisone