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Abiraterone acetate and prednisolone for metastatic castration‐resistant prostate cancer failing androgen deprivation and docetaxel‐based chemotherapy: A phase II bridging study in K orean and T aiwanese patients
Author(s) -
Kwak Cheol,
Wu Tony Tong Lin,
Lee Hyun Moo,
Wu Hsi Chin,
Hong Sung Joon,
Ou Yen Chuan,
Byun Seok Soo,
Rhim Hyou Young,
Kheoh Thian,
Wan Ying,
Yeh Howard,
Yu Margaret K,
Kim Choung Soo
Publication year - 2014
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1111/iju.12589
Subject(s) - medicine , docetaxel , prostate cancer , abiraterone acetate , urology , prostate specific antigen , chemotherapy , prednisolone , androgen deprivation therapy , oncology , adverse effect , cancer
Objectives To evaluate the safety and efficacy of abiraterone acetate and prednisolone in K orean and T aiwanese 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 T aiwanese and K orean patients with advanced metastatic castration‐resistant prostate cancer after failed docetaxel‐based chemotherapy.