title: Safety and clinical outcomes of patients treated with abiraterone acetate after docetaxel: results of the Italian Named Patient Programme.
abstract: OBJECTIVE
  To assess the safety and efficacy of abiraterone acetate (AA) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated in a compassionate named patient programme (NPP).
  
  
  METHODS
  We retrospectively reviewed the clinical records of patients with mCRPC treated with AA at the standard daily oral dose of 1000 mg plus prednisone 10 mg/day in 19 Italian hospitals.
  
  
  RESULTS
  We assessed 265 patients with mCRPC treated with AA. The most frequent (>1%) grade 3-4 toxicities were anaemia (4.2%), fatigue (4.2%), and bone pain (1.5%). The median progression-free survival was 7 months; median overall survival was 17 months after starting AA, and 35 months after the first docetaxel administration. Our study reproduced the clinical outcomes reported in the AA pivotal trial, including those relating to special populations such as the elderly, patients with a poor performance status, symptomatic patients, and patients with visceral metastases.
  
  
  CONCLUSIONS
  Our data show the safety and activity of AA when administered outside clinical trials, and confirm the findings of the post-docetaxel pivotal trial in the patients as a whole population and in special populations of specific interest.
authors.affiliation: Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.
authors.forename: Orazio
authors.initials: O
authors.lastname: Caffo
authors.forename: Ugo
authors.initials: U
authors.lastname: De Giorgi
authors.forename: Lucia
authors.initials: L
authors.lastname: Fratino
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lo Re
authors.forename: Umberto
authors.initials: U
authors.lastname: Basso
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Angelo
authors.forename: Maddalena
authors.initials: M
authors.lastname: Donini
authors.forename: Francesco
authors.initials: F
authors.lastname: Verderame
authors.forename: Raffaele
authors.initials: R
authors.lastname: Ratta
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Procopio
authors.forename: Enrico
authors.initials: E
authors.lastname: Campadelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Massari
authors.forename: Donatello
authors.initials: D
authors.lastname: Gasparro
authors.forename: Sveva
authors.initials: S
authors.lastname: Macrini
authors.forename: Caterina
authors.initials: C
authors.lastname: Messina
authors.forename: Monica
authors.initials: M
authors.lastname: Giordano
authors.forename: Daniele
authors.initials: D
authors.lastname: Alesini
authors.forename: Fable
authors.initials: F
authors.lastname: Zustovich
authors.forename: Anna P
authors.initials: AP
authors.lastname: Fraccon
authors.forename: Giovanni
authors.initials: G
authors.lastname: Vicario
authors.forename: Vincenza
authors.initials: V
authors.lastname: Conteduca
authors.forename: Francesca
authors.initials: F
authors.lastname: Maines
authors.forename: Enzo
authors.initials: E
authors.lastname: Galligioni
mesh_terms: D000069501:Abiraterone Acetate; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000736:Androstenes / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D057176:Compassionate Use Trials; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy*; D012189:Retrospective Studies; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000736:Androstenes; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D000069501:Abiraterone Acetate
keywords: abiraterone acetate; castration-resistant prostate cancer; compassionate programme; pre-treated patients; safety