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Oncology

Efficacy and safety of post-docetaxel therapies in metastatic castration-resistant prostate cancer: a systematic review of the literature

, , , &
Pages 1995-2008 | Received 21 Feb 2017, Accepted 09 Jun 2017, Published online: 10 Jul 2017
 

Abstract

Objective: Prostate cancer is a highly prevalent form of cancer in older men and is one of the leading causes of death from cancer in men across the globe. Many therapeutic agents have been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), particularly as a post-docetaxel treatment strategy. The objective of this systematic literature review was to assess published efficacy and safety data for select mCRPC therapies – such as abiraterone, cabazitaxel, and enzalutamide – in the post-docetaxel setting.

Methods: Database searches of MEDLINE, Embase, and Cochrane CENTRAL, in conjunction with hand searches of multiple congress abstracts, yielded 13 randomized studies and 107 non-randomized studies that met the inclusion criteria.

Results: Randomized studies demonstrated significant improvements in median overall survival (OS) outcomes over placebo for abiraterone (15.8 vs. 11.2 months) and enzalutamide (18.4 vs. 13.6 months), and similar significant improvements were noted for cabazitaxel over mitoxantrone (15.1 vs. 12.7 months). Differences in progression-free survival (PFS) were similarly significant, although variance in the criteria for measuring PFS may limit the extent to which these outcomes can be compared between studies. Non-randomized evidence included multiple publications from several early access and compassionate use programs with a primary objective to report safety outcomes. Results from these studies largely reflected the findings in randomized trials.

Conclusions: Overall, there is a growing body of evidence for post-docetaxel treatment options available in patients with mCRPC. Further head-to-head trials or indirect treatment comparisons may be a valuable method to assess the comparative efficacy of these therapies.

Transparency

Declaration of funding

This research was funded by Sanofi.

Author contributions: N.S., J.V.-O., M.R., M.G. and O.S. were involved in the conception and study design, as well as the analysis and interpretation of the data. N.S. and M.R. were involved in drafting the paper, and N.S., J.V.-O., M.R., M.G. and O.S. revised it critically for intellectual content. All authors were involved in final approval of the manuscript and take accountability for all aspects of the work.

Declaration of financial/other relationships

Employees of Sanofi were involved in the study design; the collection, analysis, and interpretation of data; the writing of the manuscript; and the decision to submit the manuscript for publication. N.S. has disclosed that he is an employee of Precision Health Economics, which provides consulting and other research services to pharmaceutical, device, governmental, and non-governmental organizations. J.V.-O. has disclosed that she was an employee of Precision Health Economics at the time the manuscript was drafted. M.R. has disclosed that she was a consultant for Precision Health Economics at the time the manuscript was drafted. M.G. has disclosed that she is an employee of Sanofi. O.S. has disclosed that he is a consultant for Precision Health Economics, and has been a consultant and investigator for Sanofi, Bayer, and Janssen Pharmaceutical. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors would like to acknowledge the contributions of Denise Galipeau and Cody Patton for their assistance with elements of the systematic review process and editorial support.

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