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

Authors

null

Nadine Houede

CHU Carémeau, Nîmes, France

Nadine Houede , Philippe Beuzeboc , Sophie Gourgou , Diego Tosi , Laura Moise , Gwenaelle Gravis , Remy Delva , Aude Flechon , Igor Latorzeff , Jean-Marc Ferrero , Stephane Oudard , Sophie Tartas , Brigitte Laguerre , Delphine Topart , Guilhem Roubaud , Hanane Agherbi , Xavier Rebillard , David Azria

Organizations

CHU Carémeau, Nîmes, France, Medical Oncology Department, Institut Curie, Paris, France, Biostatistics Unit, CTD INCa, Montpellier Cancer Institute, Montpellier, France, Institut régional du Cancer de Montpellier, Val d’Aurelle, Montpellier, France, Centre François Baclesse, Caen, France, Medical Oncology, Institut Paoli Calmette, Hôpital de Jour, Marseille, France, Centre Paul Papin, Angers, France, Centre Léon Bérard, Lyon, France, Clinique Pasteur Groupe Oncorad Garonne, Toulouse, France, Department d'Oncologie Medicale, Centre Antoine Lacassagne, Nice, France, Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris, France, University of Lyon, Centre Hospitalier Lyon Sud, Pierre-Bénite, France, Centre Eugène Marquis, Rennes, France, CHU Montpellier, Montpellier, France, Department of Medical Oncology, Institut Bergonie, Bordeaux, France, Clinique Beausoleil, Montpellier, France, Institut Régional du Cancer Montpellier, Montpellier, France

Research Funding

No funding sources reported

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 use authorisation (TUA) 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 TUA. Methods: Between December 2010 and July 2011, we conducted an ambispective, multicentric cohort study and investigated data from 20 centres participating to the AA TUA 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.

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Abstract Details

Meeting

2015 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session B: Prostate, Penile, Testicular, and Urethral Cancers, and Urothelial Carcinoma

Track

Urothelial Carcinoma,Prostate Cancer,Penile, Urethral, and Testicular Cancers

Sub Track

Prostate Cancer - Advanced Disease

Citation

J Clin Oncol 33, 2015 (suppl 7; abstr 264)

DOI

10.1200/jco.2015.33.7_suppl.264

Abstract #

264

Poster Bd #

D7

Abstract Disclosures