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Comparison of abiraterone acetate versus ketoconazole in patients with metastatic castration resistant prostate cancer refractory to docetaxel
Author(s) -
Peer Avivit,
Gottfried Maya,
Sinibaldi Victoria,
Carducci Michael A.,
Eisenberger Mario A.,
Sella Avishay,
LeibowitzAmit Raya,
Berger Raanan,
Keizman Daniel
Publication year - 2014
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/pros.22765
Subject(s) - ketoconazole , docetaxel , medicine , abiraterone acetate , prostate cancer , oncology , refractory (planetary science) , chemotherapy , urology , gastroenterology , cancer , androgen deprivation therapy , dermatology , antifungal , physics , astrobiology
BACKGROUND Abiraterone, a potent CYP 17 inhibitor, is standard treatment in docetaxel refractory, metastatic castrate resistant prostate cancer (mCRPC). However, in countries where abiraterone has not been approved yet, or for patients who cannot afford it, ketoconazole is used as an alternative CYP 17 inhibitor. Although preclinical data suggests that ketoconazole is a less potent inhibitor of CYP 17, there are limited clinical data comparing both agents. We aimed to compare the clinical effectiveness of abiraterone versus ketoconazole in docetaxel refractory mCRPC. METHODS Records from mCRPC patients treated with ketoconazole (international multicenter database, n = 162) were reviewed retrospectively. Twenty‐six patients treated post docetaxel were individually matched by clinicopathologic factors to patients treated with abiraterone (national multicenter database, n = 140). We compared the PSA response, biochemical and radiological progression free survival (PFS), and overall survival (OS) between the groups. PFS and OS were determined by Cox regression. RESULTS The groups were matched by Gleason score, pre‐treatment disease extent, ECOG PS, pre‐treatment risk category (Keizman, Oncologist 2012). Furthermore, they were balanced regarding other known confounding risk factors. In the groups of abiraterone versus ketoconazole, PSA response was 46% versus 19% (OR 4.3, P = 0.04), median biochemical PFS 7 versus 2 months (HR 1.54, P = 0.02), median radiological PFS 8 versus 2.5 months (HR 1.8, P = 0.043), median OS 19 versus 11 months (HR 0.53, P = 0.79), and treatment interruption d/t severe adverse events 8% (n = 2) versus 31% (n = 8) (0R 0.6, P = 0.023). CONCLUSIONS In docetaxel refractory mCRPC, the outcome of abiraterone treatment may be superior to ketoconazole. Prostate 74:433–440, 2014 . © 2013 Wiley Periodicals, Inc.