title: Phase II study of docetaxel re-treatment in docetaxel-pretreated castration-resistant prostate cancer.
abstract: OBJECTIVE
  To determine the activity and tolerability of docetaxel re-treatment after first-line therapy with docetaxel in castration-resistant prostate cancer (CRPC).
  
  
  METHODS
  Between November 2005 and January 2009, 45 patients initially responding to docetaxel and then experiencing disease progression after a period of biochemical remission of at least 5 months were enrolled in a prospective multicenter study and re-treated with docetaxel. The primary endpoint was the biochemical response (biochemical partial response defined as > 50% prostate-specific antigen [PSA] decline); secondary endpoints were objective response, toxicity, progression-free survival (PFS) and overall survival (OS).
  
  
  RESULTS
  Partial PSA responses were observed in 11 patients (24.5%), 4 (25%) of whom also had an objective response. The treatment was well tolerated, with grade 1-2 neutropenia, thrombocytopenia, vomiting and peripheral neuropathy noted in 18 (40%), 11 (24.5%), 8 (17.8%), and 6 (13.3%) patients, respectively. The most common grade 3 toxicity was neutropenia, which was observed in 8 patients (17.8%). Median PFS was 5 months and median OS was 13 months.
  
  
  CONCLUSIONS
  Docetaxel re-treatment preserves anti-tumour activity and is well tolerated in a selected population of pretreated patients with CRPC. Further randomized trials are needed to confirm our preliminary results.
authors.affiliation: Dipartimento di Endocrinologia ed Oncologia Clinica e Molecolare, Università Federico II, Napoli, Italy. giuseppedilorenzoncol@hotmail.com
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: Carlo
authors.initials: C
authors.lastname: Buonerba
authors.forename: Adriana
authors.initials: A
authors.lastname: Faiella
authors.forename: Pasquale
authors.initials: P
authors.lastname: Rescigno
authors.forename: Mimma
authors.initials: M
authors.lastname: Rizzo
authors.forename: Riccardo
authors.initials: R
authors.lastname: Autorino
authors.forename: Sisto
authors.initials: S
authors.lastname: Perdonà
authors.forename: Nando
authors.initials: N
authors.lastname: Riccardi
authors.forename: Sarah
authors.initials: S
authors.lastname: Scagliorini
authors.forename: Florinda
authors.initials: F
authors.lastname: Scognamiglio
authors.forename: Daniele
authors.initials: D
authors.lastname: Masala
authors.forename: Matteo
authors.initials: M
authors.lastname: Ferro
authors.forename: Giovannella
authors.initials: G
authors.lastname: Palmieri
authors.forename: Michele
authors.initials: M
authors.lastname: Aieta
authors.forename: Alfredo
authors.initials: A
authors.lastname: Marinelli
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Altieri
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
authors.forename: Giacomo
authors.initials: G
authors.lastname: Cartenì
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000077143:Docetaxel; D004812:Epidemiologic Methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D019233:Retreatment; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D017430:Prostate-Specific Antigen