title: Safety and Clinical Outcomes of Abiraterone Acetate After Docetaxel in Octogenarians With Metastatic Castration-Resistant Prostate Cancer: Results of the Italian Compassionate Use Named Patient Programme.
abstract: Metastatic castration-resistant prostate cancer mainly affects older men, opening issues about the efficacy and safety of therapies in this population. We have demonstrated that abiraterone, a selective androgen biosynthesis inhibitor, is a safe and active therapeutic option in a subgroup of 47 very elderly adults (aged > 80 years) enrolled in the Italian named patient program, with a tolerability profile and clinical outcomes comparable to those of younger population.
  
  
  BACKGROUND
  Prostate cancer mainly affects elderly men, who are often frail and whose reduced physiological reserves and multiple comorbidities increase the risk of side effects. The availability of new drugs has improved the overall survival (OS) of patients with castration-resistant prostate cancer (CRPC) but has increased the number of very elderly CRPC patients receiving anticancer drugs, raising questions about their efficacy and safety in this population.
  
  
  METHODS
  We assessed the tolerability of abiraterone (AA) in a cohort of very elderly adults with metastatic CRPC (mCRPC) enrolled in the Italian AA named patient program and analyzed their clinical outcomes. We retrospectively reviewed the clinical records of 47 mCRPC patients aged > 80 years who had received AA after docetaxel. The Kaplan-Meier method was used to calculate OS and progression-free survival (PFS). Safety and clinical outcomes were also analyzed by age group (< 80 and > 80 years). Cox regression analysis was used to calculate the differences in PFS and OS between the groups according to the stratification variables.
  
  
  RESULTS
  In very elderly men, the prostate-specific antigen response rate was 48.9%, and the median PFS and OS were 8 and 18 months, respectively. The differences in toxicities between the older and younger age groups were not major. The limitation of the present study was mainly its retrospective nature.
  
  
  CONCLUSIONS
  Our data show that AA is active and safe in very elderly patients and leads to outcomes similar to those observed in younger patients, thus confirming that AA is a manageable therapeutic option for this patient population.
authors.affiliation: Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Maines
authors.affiliation: Medical Oncology Department, Santa Chiara Hospital, Trento, Italy. Electronic address: orazio.caffo@apss.tn.it.
authors.forename: Orazio
authors.initials: O
authors.lastname: Caffo
authors.affiliation: Medical Oncology Department, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Ugo
authors.initials: U
authors.lastname: De Giorgi
authors.affiliation: Medical Oncology Department, National Cancer Institute, Aviano, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Fratino
authors.affiliation: Medical Oncology Department, Santa Maria degli Angeli Hospital, Pordenone, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lo Re
authors.affiliation: Medical Oncology Unit 1, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.
authors.forename: Vittorina
authors.initials: V
authors.lastname: Zagonel
authors.affiliation: Medical Oncology Department, San Vincenzo Hospital, Taormina, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Angelo
authors.affiliation: Medical Oncology Department, Civil Hospital, Cremona, Italy.
authors.forename: Maddalena
authors.initials: M
authors.lastname: Donini
authors.affiliation: Medical Oncology Department, Villa Sofia Cervello Hospital, Palermo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Verderame
authors.affiliation: Medical Oncology Department, Unicampus University, Rome, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Ratta
authors.affiliation: Medical Oncology Department, National Cancer Institute, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Procopio
authors.affiliation: Medical Oncology Department, Civil Hospital, Lugo di Romagna, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Campadelli
authors.affiliation: Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Massari
authors.affiliation: Medical Oncology Department, Civil Hospital, Parma, Italy.
authors.forename: Donatello
authors.initials: D
authors.lastname: Gasparro
authors.affiliation: Medical Oncology Department, Santa Maria della Misericordia Hospital, Udine, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Ermacora
authors.affiliation: Medical Oncology Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Messina
authors.affiliation: Medical Oncology Department, Sant'Anna Hospital, Como, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Giordano
authors.affiliation: Department of Radiological, Oncological and Anatomopathological Sciences, La Sapienza, University of Rome, Rome, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Alesini
authors.affiliation: Medical Oncology Unit 1, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Basso
authors.affiliation: Medical Oncology Department, Casa di Cura Pederzoli, Peschiera del Garda, Italy.
authors.forename: Anna Paola
authors.initials: AP
authors.lastname: Fraccon
authors.affiliation: Medical Oncology Department, San Giacomo Apostolo Hospital, Castelfranco Veneto, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Vicario
authors.affiliation: Medical Oncology Department, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
authors.forename: Vincenza
authors.initials: V
authors.lastname: Conteduca
authors.affiliation: Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.
authors.forename: Enzo
authors.initials: E
authors.lastname: Galligioni
mesh_terms: D000069501:Abiraterone Acetate / Q000008:administration & dosage*; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D057176:Compassionate Use Trials; D018572:Disease-Free Survival; D000077143:Docetaxel; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D016016:Proportional Hazards Models; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000401:mortality; D012189:Retrospective Studies; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D000069501:Abiraterone Acetate
keywords: Abiraterone; Castration-resistant prostate cancer; Elderly; Outcomes; Safety