title: Abiraterone acetate in patients with metastatic castration-resistant prostate cancer: long term outcome of the Temporary Authorization for Use programme in France.
abstract: BACKGROUND
  COU-AA-301 trial has proved that abiraterone acetate (AA), a selective inhibitor of androgen biosynthesis, improved overall survival (OS) of patients with metastatic castration resistant prostate cancer (mCRPC) after a first line of docetaxel. Based on this result, a Temporary Authorization for Use (TAU) was performed between December 2010 and July 2011 to provide patients with mCRPC the opportunity to receive AA before its commercialization. The aim of this study was to evaluate safety and efficacy of AA treatment in this TAU.
  
  
  METHODS
  Between December 2010 and July 2011, we conducted an ambispective, multicentric cohort study and investigated data from 20 centres participating to the AA TAU for patients presenting mCRPC and already treated by a first line of chemotherapy (CT). Statistical analyses of the data were performed using the Stata software v13 to identify predictive and prognostic factors.
  
  
  RESULTS
  Among the 408 patients, 306 were eligible with a follow-up at 3 years. Median OS was 37.1 months from beginning of CT and 14.6 months from AA introduction. 211 patients (69%) received ≥ 3 months of AA and 95 patients (31%) were treated less than 3 months. In the multivariate analyses, duration of AA was significantly correlated with PSA decrease at 3 months. Additionally, shorter time under AA treatment, presence of multiple sites of metastasis and previous hormonal treatment duration were three independent factors associated with poorer OS. At the time of analysis ten patients were still under treatment for more than 3 years.
  
  
  CONCLUSIONS
  Biochemical response monitored by PSA changes at 3 months is a strong predictive factor for AA treatment duration. Some high responders' patients could beneficiate from AA for more than 3 years.
authors.affiliation: Department of Medical Oncology, Nîmes University Hospital, Nîmes, France. nadine.houede@chu-nimes.fr.|INSERM U1194, Montpellier, France. nadine.houede@chu-nimes.fr.
authors.forename: Nadine
authors.initials: N
authors.lastname: Houédé
authors.affiliation: Department of Medical Oncology, Curie Institute, Paris, France. philippe.beuzeboc@curie.net.
authors.forename: Philippe
authors.initials: P
authors.lastname: Beuzeboc
authors.affiliation: Biostatistics Unit, ICM - Montpellier Cancer Institute, Montpellier, France. sophie.gourgou@icm.unicancer.fr.
authors.forename: Sophie
authors.initials: S
authors.lastname: Gourgou
authors.affiliation: Department of Medical Oncology, ICM - Montpellier Cancer Institute, Montpellier, France. diego.tosi@icm.unicancer.fr.
authors.forename: Diego
authors.initials: D
authors.lastname: Tosi
authors.affiliation: Department of Medical Oncology, François Baclesse Cancer Centre, Caen, France. l.moise@baclesse.fr.
authors.forename: Laura
authors.initials: L
authors.lastname: Moise
authors.affiliation: Department of Medical Oncology, Paoli Calmette Institute, Marseille, France. gravisg@ipc.unicancer.fr.
authors.forename: Gwenaëlle
authors.initials: G
authors.lastname: Gravis
authors.affiliation: Department of Medical Oncology, Paul Papin Cancer Centre, Angers, France. r.delva@unimedia.fr.
authors.forename: Remy
authors.initials: R
authors.lastname: Delva
authors.affiliation: Department of Medical Oncology, Leon Bérard Cancer Centre, Lyon, France. aude.flechon@lyon.unicancer.fr.
authors.forename: Aude
authors.initials: A
authors.lastname: Fléchon
authors.affiliation: Clinique Pasteur, Toulouse, France. i.latorzeff@clinique-pasteur.com.
authors.forename: Igor
authors.initials: I
authors.lastname: Latorzeff
authors.affiliation: Department of Medical Oncology, Antoine Lacassagne Cancer Centre, Nice, France. jean-marc.ferrero@nice.unicancer.fr.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ferrero
authors.affiliation: Department of Medical Oncology, Georges Pompidou European Hospital, Paris, France. stephane.oudard@egp.aphp.fr.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Oudard
authors.affiliation: Department of Medical Oncology, Lyon University Hospital, Lyon, France. sophie.tartas@chu-lyon.fr.
authors.forename: Sophie
authors.initials: S
authors.lastname: Tartas
authors.affiliation: Department of Medical Oncology, Eugène Marquis Cancer Centre, Rennes, France. b.laguerre@rennes.unicancer.fr.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Laguerre
authors.affiliation: Department of Medical Oncology, Montpellier University Hospital, Montpellier, France. d-topart@chu-montpellier.fr.
authors.forename: Delphine
authors.initials: D
authors.lastname: Topart
authors.affiliation: Department of Medical Oncology, Bergonié Cancer Institute, Bordeaux, France. g.roubaud@bordeaux.unicancer.fr.
authors.forename: Guilhem
authors.initials: G
authors.lastname: Roubaud
authors.affiliation: INSERM U1194, Montpellier, France. hanane.agherbi@inserm.fr.
authors.forename: Hanane
authors.initials: H
authors.lastname: Agherbi
authors.affiliation: Department of Urology, Clinique Beausoleil, Montpellier, France. xavier.rebillard@wanadoo.fr.
authors.forename: Xavier
authors.initials: X
authors.lastname: Rebillard
authors.affiliation: INSERM U1194, Montpellier, France. david.azria@montpellier.unicancer.fr.|Department of Radiation Oncology, ICM - Montpellier Cancer Institute, Montpellier, France. david.azria@montpellier.unicancer.fr.
authors.forename: David
authors.initials: D
authors.lastname: Azria
mesh_terms: D000069501:Abiraterone Acetate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D015331:Cohort Studies; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D011379:Prognosis; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000069501:Abiraterone Acetate