Abiraterone acetate post-docetaxel for metastatic castration-resistant prostate cancer in the Belgian compassionate use program

BACKGROUND - Abiraterone acetate (AA) is licensed for treating metastatic castration-resistant prostate cancer (mCRPC). Real-world data on oncological outcome after AA are scarce. The current study assesses efficacy and safety of AA in mCRPC patients previously treated with docetaxel who started treatment during the Belgian compassionate use program (January 2011-July 2012).

PATIENTS AND METHODS - Records from 368 patients with mCRPC from 23 different Belgian hospitals who started AA 1000mg per day with 10mg prednisone or equivalent were retrospectively reviewed (September 2013-December 2014). Prostate-specific antigen (PSA) response (decrease≥50%), time to PSA progression (increase>50% over PSA nadir in case of PSA response/>25% in absence of PSA response), time to radiographic progression (on bone scans or for soft tissue lesions using Response Evaluation Criteria In Solid Tumors 1. 1), overall survival and adverse event rate (Common Terminology Criteria for Adverse Events v4. 03) were analyzed. Kaplan-Meier statistics were applied.

RESULTS - Overall, 92 patients (25%) had an Eastern Cooperative Oncology Group performance status≥2. Median age was 73 years, median PSA was 103ng/dl. PSA response was observed in 131 patients (37. 4%). Median time to PSA and radiographic progression was 4. 1 months (95% CI: 3. 6-4. 6) and 5. 8 months (5. 3-6. 4), respectively. Median overall survival was 15. 1 months (13. 6-16. 6). Most common grade 3 to 4 adverse events were anemia (13. 9%), hypokalemia (7. 3%), fatigue (6. 8%), and pain (6. 3%). Median duration of AA treatment was 5. 3 months (interquartile range: 2. 8-10. 3). The main study limitation is its retrospective design.

CONCLUSIONS - These real-world data on post-docetaxel AA efficacy are in line with the COU-AA-301 trial. Importantly, incidence of severe anemia and hypokalemia is up to 50% higher than reported in previous studies.

Urologic oncology. 2016 Feb 02 [Epub ahead of print]

Charles Van Praet, Sylvie Rottey, Fransien Van Hende, Gino Pelgrims, Wim Demey, Filip Van Aelst, Wim Wynendaele, Thierry Gil, Peter Schatteman, Bertrand Filleul, Dennis Schallier, Jean-Pascal Machiels, Dirk Schrijvers, Els Everaert, Lionel D'Hondt, Patrick Werbrouck, Joanna Vermeij, Jeroen Mebis, Marylene Clausse, Marika Rasschaert, Joanna Van Erps, Jolanda Verheezen, Jan Van Haverbeke, Jean-Charles Goeminne, Nicolaas Lumen

Department of Urology, Ghent University Hospital, Ghent, Belgium.  Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium. , Department of Medical Oncology, University Hospital Leuven, Leuven, Belgium. , Department of Medical Oncology, AZ Turnhout, Turnhout, Belgium. , Department of Medical Oncology, AZ Klina, Kalmthout, Belgium. , Department of Medical Oncology, AZ Delta, Roeselare, Belgium. , Department of Medical Oncology, Imelda Hospital, Bonheiden, Belgium. , Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. , Department of Urology, Onze-Lieve-Vrouw Hospital, Aalst, Belgium. , Department of Medical Oncology, Hopital De Jolimont, Haine Saint Paul, Belgium. , Department of Medical Oncology, University Hospital Brussels, Jette, Belgium. , Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint Luc, Brussels, Belgium. , Department of Medical Oncology, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium. , Department of Medical Oncology, AZ Nikolaas, Sint-Niklaas, Belgium. , Department of Medical Oncology, CHU Dinant-Godinne, Yvoir, Belgium. , Department of Urology, AZ Groeninge, Kortrijk, Belgium. , Department of Medical Oncology, ZNA Jan Palfijn, Merksem, Belgium. , Department of Medical Oncology, AZ Jessa, Hasselt, Belgium. , Department of Medical Oncology, St Luc Bouge, Namur, Belgium. , Department of Medical Oncology, UZA/AZ Monica, Antwerp, Belgium. , Department of Medical Oncology, Algemeen Stedelijk Ziekenhuis, Aalst, Belgium. , Department of Medical Oncology, AZ Sint-Trudo, Sint-Truiden, Belgium. , Department of Urology, AZ Sint-Andries, Tielt, Belgium. , Department of Medical Oncology, Sainte-Elisabeth, Namur, Belgium. , Department of Urology, Ghent University Hospital, Ghent, Belgium.

PubMed

E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe