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. (6th August 2014)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: International journal of urology. Volume 21:Number 12(2014)
• Page Start: 1239
• Page End: 1244
• Publication Date: 2014-08-06
• Subjects: Urology -- Periodicals; Genitourinary organs -- Periodicals; Urologic Diseases -- Periodicals; 616.6005
• DOI: 10.1111/iju.12589
• Languages: English
• ISSNs: 0919-8172

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="iju12589-sec-0001" sec-type="section"> <title>Objectives</title> <p>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.</p> </sec> <sec id="iju12589-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="iju12589-sec-0003" sec-type="section"> <title>Results</title> <p>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%).</p> </sec> <sec id="iju12589-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>