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Comparison of abiraterone acetate versus ketoconazole in patients with metastatic castration resistant prostate cancer refractory to docetaxel.
Peer, Avivit; Gottfried, Maya; Sinibaldi, Victoria; Carducci, Michael A; Eisenberger, Mario A; Sella, Avishay; Leibowitz-Amit, Raya; Berger, Raanan; Keizman, Daniel.
Afiliação
  • Peer A; Department of Oncology, Rambam Medical Center, Haifa, Israel.
Prostate ; 74(4): 433-40, 2014 Apr.
Article em En | MEDLINE | ID: mdl-24338986
ABSTRACT

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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata / Orquiectomia / Taxoides / Androstadienos / Cetoconazol / Antineoplásicos Tipo de estudo: Observational_studies / Risk_factors_studies Limite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Prostate Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Israel

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias da Próstata / Orquiectomia / Taxoides / Androstadienos / Cetoconazol / Antineoplásicos Tipo de estudo: Observational_studies / Risk_factors_studies Limite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Prostate Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Israel