781P - Analysis of European patients enrolled in a global early access protocol with abiraterone acetate for metastatic castration-resistant prostate canc...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Prostate Cancer
Biological Therapy
Presenter Daniel Castellano
Citation Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336
Authors D. Castellano1, S. Bracarda2, M. Tucci3, O. Capoun4, V. Matveev5, G. Bodoky6, G. Fountzilas7, G. Kacso8, M. Borre9, I. Skoneczna10, A. Londhe11, P. De Porre12, D. Atlan13, B. Goon14, E. Lee15, T. McGowan16, V. Naini17, A. Molina18, C.N. Sternberg19
  • 1Medical Oncology, Hospital Universitario 12 De Octubre Medical Oncology, 28041 - Madrid/ES
  • 2Department Of Oncology, San Donato Hospital Arezzo, Istituto Toscano Tumori (ITT), Arezzo/IT
  • 3Medical Oncology, San Luigi Hospital Orbassano, Orbassano/IT
  • 4Medicine, General University Hospital and Charles University, Prague/CZ
  • 5Department Of Urology, Russian Cancer Research Center n.a. N.N. Blokhin, Moscow/RU
  • 6Department Of Oncology, Szent László Hospital, Budapest/HU
  • 7Medical Oncology, Papageorgiou General Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki/GR
  • 8Medicine, University of Medicine and Pharmacy, Cluj Napoca/RO
  • 9Medicine, Aarhus University Hospital, Skejby, Aarhus/DK
  • 10Medicine, Maria Sklodowska Curie Memorial Cancer Centre, Warsaw/PL
  • 11Clinical Biostatistics, Janssen Research & Development, Horsham/US
  • 12Oncology Development, Janssen Research & Development, Beerse/BE
  • 13Epc - Jemea Medical Affairs Hematology/oncology, Janssen Europe, Paris/FR
  • 14Us Maf Cpl Rate, Janssen Research & Development, Horsham/US
  • 15Janssen Emea Medical Affairs, Janssen Research & Development, Beerse/BE
  • 16Med Group Oncology T, Janssen Research & Development, Horsham/US
  • 17Wc Clinical Oncology, Janssen Research & Development, Los Angeles/US
  • 18Oncology Ta Admin Pa, Janssen Research & Development, Menlo Park/US
  • 19Department Of Medical Oncology, San Camillo and Forlanini Hospitals, Rome/IT



Following release of COU-AA-301 pivotal trial data, a global early access protocol (EAP) was opened to enable preapproval access to abiraterone acetate (AA) for metastatic castration-resistant prostate cancer (mCRPC) patients (pts) who had progressed after 1 or 2 chemotherapy regimens, 1 of which contained a taxane, and for whom no approved alternative treatment was available. In COU-AA-301, AA + prednisone (P) significantly prolonged median overall survival by 4.6 months in post-docetaxel mCRPC pts, with a 26% reduction (hazard ratio = 0.74 [95% confidence interval (CI), 0.64-0.86]; p < 0.0001) in the risk of death vs P alone. We report the outcomes from pts in the EAP who were enrolled from 10 countries in Europe.


Globally, 2314 mCRPC pts were enrolled and 98.5% of pts had previously received docetaxel. Of those enrolled, 1171 (51%) were European. Pts received AA (1000 mg/d PO) + P (5 mg bid) and continued on the EAP until disease progression, or until AA became available and reimbursed in the respective country. The primary end point was the number of clinically important adverse events (AEs), including ≥ Grade 3 or serious AEs (NCI-CTCAE v 4.0) occurring during treatment and within 30 days of treatment discontinuation. Time to prostate-specific antigen progression (TTPP) and time to clinical progression (TTCP) were used to guide treatment decisions.


The median age of European pts was 71 years. 90% and 39% of pts had bone and soft-tissue metastases, respectively. Median duration of therapy was 6.4 months. Median TTPP (385 events) was 9.3 months (95% CI, 8.5-11) and median TTCP (412 events) was 13 months (95% CI, 12-14.8). Grade 3/4 AEs of special interest were hepatotoxicity (6.7%), hypertension (5.1%), cardiac disorders (1.5%), osteoporosis (1.1%), fluid retention/edema (0.9%), and hypokalemia (0.8%). Study discontinuations due to AEs or death were ≤ 8% each.


These final analysis results reveal that AA + P is safe and effective across geographically diverse European investigational sites. This EAP enables an early insight into real-world clinical practice in a clinical trial framework.


S. Bracarda: has served as an advisory board member for Jannsen, Astellas, Bayer, and Genentech; O. Capoun: has received travel and congress fee support from Janssen, Ipsen, and Astellas; G. Bodoky: has served as an advisory board member for Pfizer, Novartis, Roche, Amgen, Janssen, Lilly, and GSK.

I. Skoneczna: has received speaker fees from Janssen. A. Londhe, P. De Porre, D. Atlan, B. Goon, E. Lee, T. McGowan and A. Molina: is an employee of Janssen and holds stock in Johnson & Johnson; V. Naini: is an employee of Janssen; C.N. Sternberg: has received honoraria from Astellas, Johnson & Johnson, Ipsen, Bayer, and Millennium. All other authors have declared no conflicts of interest.