Abiraterone acetate in patients with metastatic castration-resistant prostate cancer: long term outcome of the Temporary Authorization for Use programme in France - Inserm - Institut national de la santé et de la recherche médicale Access content directly
Journal Articles BMC Cancer Year : 2015

Abiraterone acetate in patients with metastatic castration-resistant prostate cancer: long term outcome of the Temporary Authorization for Use programme in France

Philippe Beuzeboc
  • Function : Author
  • PersonId : 975624
Laura Moise
  • Function : Author
  • PersonId : 975627
Remy Delva
  • Function : Author
  • PersonId : 975628
Aude Fléchon
  • Function : Author
  • PersonId : 975629
Igor Latorzeff
  • Function : Author
  • PersonId : 949033
Jean-Marc Ferrero
Stéphane Oudard
  • Function : Author
  • PersonId : 854064
Guilhem Roubaud
  • Function : Author
  • PersonId : 975634

Abstract

AbstractBackgroundCOU-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.MethodsBetween 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.ResultsAmong 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.ConclusionsBiochemical 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.
Fichier principal
Vignette du fichier
12885_2015_Article_1257.pdf (667.31 Ko) Télécharger le fichier
Origin : Publication funded by an institution
Loading...

Dates and versions

inserm-01264474 , version 1 (29-01-2016)

Identifiers

Cite

Nadine Houédé, Philippe Beuzeboc, Sophie Gourgou, Diego Tosi, Laura Moise, et al.. Abiraterone acetate in patients with metastatic castration-resistant prostate cancer: long term outcome of the Temporary Authorization for Use programme in France. BMC Cancer, 2015, 15 (1), pp.222. ⟨10.1186/s12885-015-1257-2⟩. ⟨inserm-01264474⟩
351 View
152 Download

Altmetric

Share

Gmail Facebook X LinkedIn More