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Abstract

IMPORTANCE Regional variation in opioid use may be attenuated when pharmaceuticalsponsored trials include care that is often standardized by protocols. Understanding suchvariation is important for global trials that sometimes include time to opioid use as an endpoint.OBJECTIVE To identify whether regional and country-level variation in opioid use existsamong prostate cancer clinical trials across the world.DESIGN, SETTING, AND PARTICIPANTS International phase 3 randomized clinical trials withpatients with metastatic prostate cancer and initiation from January 1, 2008, or later wereidentified through internal databases of the US Food and Drug Administration. Data ofpatients in the intention-to-treat population from each trial were pooled. Descriptive andregression analyses of the collected data were conducted from September 2018 toFebruary 2019.EXPOSURES Cancer therapy.MAIN OUTCOMES AND MEASURES Opioid use data were from concomitant medicationsreported in the database for each trial. Logistic regression models, descriptive statistics,and χ2tests were used to compare opioid use across world regions while adjusting for patientage, presence of visceral disease, bony disease, and baseline Eastern Cooperative OncologyGroup Performance Status score and pain score.RESULTS In total, 9670 patients (mean [SD] age of 69.2 [8.3] years) from 8 prostate cancerclinical trials in 46 countries were included. Patients in Eastern Europe (adjusted odds ratio[AOR], 0.19; 95% CI, 0.16-0.22) and Asia (AOR, 0.31; 95% CI, 0.25-0.38) were less likely touse opioids compared with patients in North America. These findings held even when theanalysis was restricted to patients who reported moderate to high pain levels at baseline(Eastern Europe: AOR, 0.16 [95% CI, 0.12-0.22]; Asia: AOR, 0.47 [95% CI, 0.29-0.79]).Within North America, rates of opioid use were similar between the United States and Canada(AOR, 1.13; 95% CI, 0.93-1.37).CONCLUSIONS AND RELEVANCE This study found that, despite the clinical trial setting, opioiduse appeared to vary by world regions, suggesting that this variability should be consideredin international clinical trials.

Item Type:	Article
Authors/Creators:	Roydhouse, J and Suzman, DL and Menapace, LA and Mishra-Kalyani, PS and Sridhara, R and Blumenthal, GM and Beaver, JA and Pazdur, R and Kluetz, PG
Keywords:	clinical trial, prostate cancer, opioid
Journal or Publication Title:	JAMA Oncology
Publisher:	American Medical Association
ISSN:	2374-2445
DOI / ID Number:	10.1001/jamaoncol.2019.2971
Copyright Information:	Copyright 2019 American Medical Association
Item Statistics:	View statistics for this item

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