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BMC Urology
Published in: BMC Urology 1/2018

Open Access 01-12-2018 | Research article

Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials

Authors: Neil M. Schultz, Neal D. Shore, Simon Chowdhury, Laurence H. Klotz, Raoul S. Concepcion, David F. Penson, Lawrence I. Karsh, Hongbo Yang, Bruce A. Brown, Arie Barlev, Scott C. Flanders

Published in: BMC Urology | Issue 1/2018

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Abstract

Background

This analysis estimated the number needed to treat with enzalutamide versus bicalutamide to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer who would obtain clinical benefit regarding progression-free survival, radiographic progression-free survival, or no prostate-specific antigen progression at 1 and 2 years following treatment initiation.

Methods

Clinical event rates were obtained from the STRIVE (NCT01664923) and TERRAIN (NCT01288911) trials, and the number needed to treat was the inverse of the absolute rate difference between the event rates of enzalutamide and bicalutamide. The 95% Confidence Interval of the number needed to treat was derived from the 95% Confidence Interval of the event rate difference.

Results

Using STRIVE data (patients with metastatic disease: n = 128 enzalutamide; n = 129 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer with progression-free survival were 2.0 and 2.8, respectively; with radiographic progression-free survival, 2.6 and 3.0, respectively; and without prostate-specific antigen progression, 1.8 and 2.4, respectively. Using TERRAIN data (n = 184 enzalutamide; n = 191 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with progression-free survival were 4.3 and 3.7, respectively; with radiographic progression-free survival, 10.0 and 2.8, respectively; and without prostate-specific antigen progression, 2.1 and 3.2, respectively.

Conclusions

The combined data from TERRAIN and STRIVE demonstrated that treating chemotherapy-naïve metastatic castration-resistant prostate cancer with enzalutamide leads to more patients without clinical progression at 1 and 2 years than with bicalutamide.

Trial registration

STRIVE (NCT01664923; registration date: August 10, 2012) and TERRAIN (NCT01288911; registration date: February 1, 2011).
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Metadata
Title
Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials
Authors
Neil M. Schultz
Neal D. Shore
Simon Chowdhury
Laurence H. Klotz
Raoul S. Concepcion
David F. Penson
Lawrence I. Karsh
Hongbo Yang
Bruce A. Brown
Arie Barlev
Scott C. Flanders
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2018
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/s12894-018-0387-7

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