title: 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: OBJECTIVE
  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.
authors.affiliation: Department of Urology, Seoul National University Hospital, Seoul, Korea.
authors.forename: Cheol
authors.initials: C
authors.lastname: Kwak
authors.forename: Tony Tong Lin
authors.initials: TT
authors.lastname: Wu
authors.forename: Hyun Moo
authors.initials: HM
authors.lastname: Lee
authors.forename: Hsi Chin
authors.initials: HC
authors.lastname: Wu
authors.forename: Sung Joon
authors.initials: SJ
authors.lastname: Hong
authors.forename: Yen Chuan
authors.initials: YC
authors.lastname: Ou
authors.forename: Seok Soo
authors.initials: SS
authors.lastname: Byun
authors.forename: Hyou Young
authors.initials: HY
authors.lastname: Rhim
authors.forename: Thian
authors.initials: T
authors.lastname: Kheoh
authors.forename: Ying
authors.initials: Y
authors.lastname: Wan
authors.forename: Howard
authors.initials: H
authors.lastname: Yeh
authors.forename: Margaret K
authors.initials: MK
authors.lastname: Yu
authors.forename: Choung Soo
authors.initials: CS
authors.lastname: Kim
mesh_terms: D000368:Aged; D000728:Androgens / Q000378:metabolism*; D000736:Androstenes / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D018450:Disease Progression; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D015994:Incidence; D008297:Male; D009919:Orchiectomy; D011239:Prednisolone / Q000008:administration & dosage*; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary; D056910:Republic of Korea / Q000453:epidemiology; D015996:Survival Rate / Q000639:trends; D013624:Taiwan / Q000453:epidemiology; D043823:Taxoids / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D000728:Androgens; D000736:Androstenes; D000970:Antineoplastic Agents; D005938:Glucocorticoids; D043823:Taxoids; D000077143:Docetaxel; D011239:Prednisolone; C089740:abiraterone
keywords: abiraterone acetate; docetaxel; metastatic castration-resistant prostate cancer; prednisolone; prostate-specific antigen