title: Abiraterone acetate post-docetaxel for metastatic castration-resistant prostate cancer in the Belgian compassionate use program.
abstract: 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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: Department of Urology, Ghent University Hospital, Ghent, Belgium. Electronic address: charles.vanpraet@uzgent.be.
authors: Charles
authors: C
authors: Van Praet
authors: Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.
authors: Sylvie
authors: S
authors: Rottey
authors: Department of Medical Oncology, University Hospital Leuven, Leuven, Belgium.
authors: Fransien
authors: F
authors: Van Hende
authors: Department of Medical Oncology, AZ Turnhout, Turnhout, Belgium.
authors: Gino
authors: G
authors: Pelgrims
authors: Department of Medical Oncology, AZ Klina, Kalmthout, Belgium.
authors: Wim
authors: W
authors: Demey
authors: Department of Medical Oncology, AZ Delta, Roeselare, Belgium.
authors: Filip
authors: F
authors: Van Aelst
authors: Department of Medical Oncology, Imelda Hospital, Bonheiden, Belgium.
authors: Wim
authors: W
authors: Wynendaele
authors: Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors: Thierry
authors: T
authors: Gil
authors: Department of Urology, Onze-Lieve-Vrouw Hospital, Aalst, Belgium.
authors: Peter
authors: P
authors: Schatteman
authors: Department of Medical Oncology, Hopital De Jolimont, Haine Saint Paul, Belgium.
authors: Bertrand
authors: B
authors: Filleul
authors: Department of Medical Oncology, University Hospital Brussels, Jette, Belgium.
authors: Dennis
authors: D
authors: Schallier
authors: Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint Luc, Brussels, Belgium.
authors: Jean-Pascal
authors: JP
authors: Machiels
authors: Department of Medical Oncology, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium.
authors: Dirk
authors: D
authors: Schrijvers
authors: Department of Medical Oncology, AZ Nikolaas, Sint-Niklaas, Belgium.
authors: Els
authors: E
authors: Everaert
authors: Department of Medical Oncology, CHU Dinant-Godinne, Yvoir, Belgium.
authors: Lionel
authors: L
authors: D'Hondt
authors: Department of Urology, AZ Groeninge, Kortrijk, Belgium.
authors: Patrick
authors: P
authors: Werbrouck
authors: Department of Medical Oncology, ZNA Jan Palfijn, Merksem, Belgium.
authors: Joanna
authors: J
authors: Vermeij
authors: Department of Medical Oncology, AZ Jessa, Hasselt, Belgium.
authors: Jeroen
authors: J
authors: Mebis
authors: Department of Medical Oncology, St Luc Bouge, Namur, Belgium.
authors: Marylene
authors: M
authors: Clausse
authors: Department of Medical Oncology, UZA/AZ Monica, Antwerp, Belgium.
authors: Marika
authors: M
authors: Rasschaert
authors: Department of Medical Oncology, Algemeen Stedelijk Ziekenhuis, Aalst, Belgium.
authors: Joanna
authors: J
authors: Van Erps
authors: Department of Medical Oncology, AZ Sint-Trudo, Sint-Truiden, Belgium.
authors: Jolanda
authors: J
authors: Verheezen
authors: Department of Urology, AZ Sint-Andries, Tielt, Belgium.
authors: Jan
authors: J
authors: Van Haverbeke
authors: Department of Medical Oncology, Sainte-Elisabeth, Namur, Belgium.
authors: Jean-Charles
authors: JC
authors: Goeminne
authors: Department of Urology, Ghent University Hospital, Ghent, Belgium.
authors: Nicolaas
authors: N
authors: Lumen
mesh_terms: D000069501:Abiraterone Acetate / Q000627:therapeutic use*; D000368:Aged; D001530:Belgium; D057176:Compassionate Use Trials; D000077143:Docetaxel; D006801:Humans; D008297:Male; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy*; D012189:Retrospective Studies; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000069501:Abiraterone Acetate
keywords: Abiraterone acetate; Castration-resistant; Compassionate use; Docetaxel; Prostatic neoplasms