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Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies.

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Publication Date
2016-05
ICR Author
De Bono, Johann
Author
Bellmunt, J
Kheoh, T
Yu, MK
Smith, MR
Small, EJ
Mulders, PFA
Fizazi, K
Rathkopf, DE
Saad, F
Scher, HI
Taplin, M-E
Davis, ID
Schrijvers, D
Protheroe, A
Molina, A
De Porre, P
Griffin, TW
de Bono, JS
Ryan, CJ
Oudard, S
Type
Journal Article
Metadata
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Abstract
The duration of prior hormonal treatment can predict responses to subsequent therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).To determine if prior endocrine therapy duration is an indicator of abiraterone acetate (AA) sensitivity.Post-hoc exploratory analysis of randomised phase 3 studies examining post-docetaxel (COU-AA-301) or chemotherapy-naïve mCRPC (COU-AA-302) patients receiving AA. The treatment effect on overall survival (OS), radiographic progression-free survival (rPFS), and prostate-specific antigen (PSA) response analysed by quartile duration of prior gonadotropin-releasing hormone agonists (GnRHa) or androgen receptor (AR) antagonist.Patients were randomised to AA (1000mg, orally once daily) plus prednisone (5mg, orally twice daily) or placebo plus prednisone. Prior endocrine therapy was GnRHa (COU-AA-301, n=1127 [94%]; COU-AA-302, n=1057 [97%], 45.1 mo or 36.7 mo median duration, respectively) and/or orchiectomy (COU-AA-301, n=78 [7%] COU-AA-302, n=44 [4%]); castrated patients received prior AR antagonists (COU-AA-301, n=1015 [85%]; COU-AA-302, n=1078 [99%], 15.7 mo or 16.1 mo median duration, respectively).Cox model was used to obtain hazard ratio and associated 95% confidence interval with statistical inference by log rank statistic.Clinical benefit with AA was observed for OS, rPFS, and PSA response for nearly all quartiles with GnRHa or AR antagonists in both COU-AA-301 and COU-AA-302. In COU-AA-301, patients with a longer duration of prior endocrine therapy tended to have greater AA OS, rPFS, and PSA response benefit, with lead-time chemotherapy bias potentially impacting COU-AA-301 results. Time to castration resistance was not captured. This analysis is limited as a post-hoc exploratory analysis.In the COU-AA-301 and COU-AA-302 studies, AA produced clinical benefits regardless of prior endocrine therapy duration in patients with mCRPC.Metastatic castration-resistant prostate cancer patients derived clinical benefits with abiraterone acetate regardless of prior endocrine therapy duration.
URL
https://repository.icr.ac.uk/handle/internal/463
Collections
  • Clinical Studies
Licenseref URL
http://www.rioxx.net/licenses/all-rights-reserved
Version of record
10.1016/j.eururo.2015.10.021
Subject
Humans
Neoplasm Metastasis
Taxoids
Prednisone
Prostate-Specific Antigen
Antineoplastic Agents, Hormonal
Antineoplastic Combined Chemotherapy Protocols
Disease-Free Survival
Retreatment
Orchiectomy
Survival Rate
Double-Blind Method
Male
Gonadotropin-Releasing Hormone
Androgen Receptor Antagonists
Prostatic Neoplasms, Castration-Resistant
Abiraterone Acetate
Research team
Prostate Cancer Targeted Therapy Group
Language
eng
Date accepted
2015-10-06
License start date
2016-05
Citation
European urology, 2016, 69 (5), pp. 924 - 932

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