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

Cheol Kwak, Tony Tong Lin Wu, Hyun Moo Lee, Hsi Chin Wu, Sung Joon Hong, Yen Chuan Ou, Seok Soo Byun, Hyou Young Rhim, Thian Kheoh, Ying Wan, Howard Yeh, Margaret K. Yu, Choung Soo Kim

Research output: Contribution to journalArticle

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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 (1000mg, once daily) and prednisolone (5mg, 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 4.7months (95% confidence interval 3.7-8.3); the median overall survival was 11.8months. Two (4%) of 50 patients with measurable disease achieved partial response. The median testosterone concentration was in the castration range (1.21nmol/L) throughout the treatment period. Median dehydroepiandrosterone sulfate decreased from 0.725μmol/L (baseline) to 0.080μmol/L (cycle4). The most common adverse event was bone pain (20%); grade3/4 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.

Original languageEnglish
Pages (from-to)1239-1244
Number of pages6
JournalInternational Journal of Urology
Volume21
Issue number12
DOIs
StatePublished - 1 Dec 2014

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docetaxel
Castration
Prednisolone
Androgens
Prostatic Neoplasms
Drug Therapy
Prostate-Specific Antigen
Confidence Intervals
Dehydroepiandrosterone Sulfate
Hypokalemia
Anniversaries and Special Events
Testosterone
Abiraterone Acetate
Hypertension
Safety

Keywords

  • Abiraterone acetate
  • Docetaxel
  • Metastatic castration-resistant prostate cancer
  • Prednisolone
  • Prostate-specific antigen

Cite this

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. / 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. In: International Journal of Urology. 2014 ; Vol. 21, No. 12. pp. 1239-1244.
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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 = "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 (1000mg, once daily) and prednisolone (5mg, 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 4.7months (95{\%} confidence interval 3.7-8.3); the median overall survival was 11.8months. Two (4{\%}) of 50 patients with measurable disease achieved partial response. The median testosterone concentration was in the castration range (1.21nmol/L) throughout the treatment period. Median dehydroepiandrosterone sulfate decreased from 0.725μmol/L (baseline) to 0.080μmol/L (cycle4). The most common adverse event was bone pain (20{\%}); grade3/4 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.",
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author = "Cheol Kwak and Wu, {Tony Tong Lin} and Lee, {Hyun Moo} and Wu, {Hsi Chin} and Hong, {Sung Joon} and Ou, {Yen Chuan} and Byun, {Seok Soo} and Rhim, {Hyou Young} and Thian Kheoh and Ying Wan and Howard Yeh and Yu, {Margaret K.} and Kim, {Choung Soo}",
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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 Korean and Taiwanese patients. / 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.

In: International Journal of Urology, Vol. 21, No. 12, 01.12.2014, p. 1239-1244.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Abiraterone acetate and prednisolone for metastatic castration-resistant prostate cancer failing androgen deprivation and docetaxel-based chemotherapy

T2 - A phase II bridging study in Korean and Taiwanese patients

AU - Kwak, Cheol

AU - Wu, Tony Tong Lin

AU - Lee, Hyun Moo

AU - Wu, Hsi Chin

AU - Hong, Sung Joon

AU - Ou, Yen Chuan

AU - Byun, Seok Soo

AU - Rhim, Hyou Young

AU - Kheoh, Thian

AU - Wan, Ying

AU - Yeh, Howard

AU - Yu, Margaret K.

AU - Kim, Choung Soo

PY - 2014/12/1

Y1 - 2014/12/1

N2 - 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 (1000mg, once daily) and prednisolone (5mg, 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 4.7months (95% confidence interval 3.7-8.3); the median overall survival was 11.8months. Two (4%) of 50 patients with measurable disease achieved partial response. The median testosterone concentration was in the castration range (1.21nmol/L) throughout the treatment period. Median dehydroepiandrosterone sulfate decreased from 0.725μmol/L (baseline) to 0.080μmol/L (cycle4). The most common adverse event was bone pain (20%); grade3/4 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.

AB - 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 (1000mg, once daily) and prednisolone (5mg, 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 4.7months (95% confidence interval 3.7-8.3); the median overall survival was 11.8months. Two (4%) of 50 patients with measurable disease achieved partial response. The median testosterone concentration was in the castration range (1.21nmol/L) throughout the treatment period. Median dehydroepiandrosterone sulfate decreased from 0.725μmol/L (baseline) to 0.080μmol/L (cycle4). The most common adverse event was bone pain (20%); grade3/4 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.

KW - Abiraterone acetate

KW - Docetaxel

KW - Metastatic castration-resistant prostate cancer

KW - Prednisolone

KW - Prostate-specific antigen

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U2 - 10.1111/iju.12589

DO - 10.1111/iju.12589

M3 - Article

C2 - 25099185

AN - SCOPUS:84925294103

VL - 21

SP - 1239

EP - 1244

JO - International Journal of Urology

JF - International Journal of Urology

SN - 0919-8172

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