Abiraterone acetate and prednisolone for metastatic castration-resistant prostate cancer failing androgen deprivation and docetaxel-based chemotherapy: A phase II bridging study in Korean and Taiwanese patients - Abstract

OBJECTIVES: To evaluate the safety and efficacy of abiraterone acetate and prednisolone in Korean and Taiwanese patients with metastatic castration-resistant prostate cancer not responding to docetaxel-based chemotherapy.

METHODS: In this single-arm study, 82 metastatic castration-resistant prostate cancer patients who failed docetaxel-based chemotherapy were treated with abiraterone (1000 mg, once daily) and prednisolone (5 mg, twice daily). Patients achieving a prostate-specific antigen decline ≥50% were considered as responding.

RESULTS: A total of 35 patients (43%) achieved prostate-specific antigen response (95% confidence interval 32-54). The median time to prostate-specific antigen progression was 4.7 months (95% confidence interval 3.7-8.3); the median overall survival was 11.8 months. Two (4%) of 50 patients with measurable disease achieved partial response. The median testosterone concentration was in the castration range (1.21 nmol/L) throughout the treatment period. Median dehydroepiandrosterone sulfate decreased from 0.725 μmol/L (baseline) to 0.080 μmol/L (cycle 4). The most common adverse event was bone pain (20%); grade 3/4 adverse event of special interest were hypokalemia (7%), fluid retention and liver function abnormalities (5% each), hypertension (2%), and cardiac disorders (1%).

CONCLUSIONS: A combination of abiraterone acetate and prednisolone appears to be a favorable second-line treatment in Taiwanese and Korean patients with advanced metastatic castration-resistant prostate cancer after failed docetaxel-based chemotherapy.

Written by:
Kwak C, Wu TT, Lee HM, Wu HC, Hong SJ, Ou YC, Byun SS, Rhim HY, Kheoh T, Wan Y, Yeh H, Yu MK, Kim CS.   Are you the author?
Department of Urology, Seoul National University Hospital, Seoul, Korea.

Reference: Int J Urol. 2014 Aug 6. Epub ahead of print.
doi: 10.1111/iju.12589


PubMed Abstract
PMID: 25099185

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