Use of record linkage to evaluate treatment outcomes and trial eligibility in a real‐world metastatic prostate cancer population in Scotland

Baillie, K. et al. (2020) Use of record linkage to evaluate treatment outcomes and trial eligibility in a real‐world metastatic prostate cancer population in Scotland. Pharmacoepidemiology and Drug Safety, 29(6), pp. 653-663. (doi: 10.1002/pds.4998) (PMID:32316077)

Abstract

Purpose: New treatments are introduced into standard care based on clinical trial results. However, it is not clear if these benefits are reflected in the broader population. This study analysed the clinical outcomes of patients with metastatic castration‐resistant prostate cancer, treated with abiraterone and enzalutamide, within the Scottish National Health Service. Methods: Retrospective cohort study using record linkage of routinely collected healthcare data (study period: February 2012 to February 2017). Overall survival (OS) was analysed using Kaplan‐Meier methods and Cox Proportional Hazard models; a subgroup analysis comprised potentially trial‐eligible patients. Results: Overall, 271 patients were included and 73.8% died during the study period. Median OS was poorer than in the pivotal trials, regardless of medication and indication: 10.8 months (95% confidence interval [CI] 8.6‐15.1) and 20.9 months (95% CI 14.9‐29.0) for abiraterone, and 12.6 months (95% CI 10.5‐18.2) and 16.0 months (95% CI 9.8—not reached) for enzalutamide, post and pre chemotherapy, respectively. Only 46% of patients were potentially “trial eligible” and in this subgroup OS improved. Factors influencing survival included baseline performance status, and baseline prostate‐specific antigen, alkaline phosphatase, and albumin levels. Conclusions: Poorer prognostic features of non‐trial eligible patients impact real‐world outcomes of cancer medicines. Electronic record linkage of routinely collected healthcare data offers an opportunity to report outcomes on cancer medicines at scale and describe population demographics. The availability of such observational data to supplement clinical trial results enables patients and clinicians to make more informed treatment decisions, and policymakers to contextualise trial findings.

• Item Type: Articles
• Additional Information: This study has been part of the CMOP body of work, and as such was sponsored by the Scottish Government.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Morrison, Dr David and Wu, Professor Olivia and Jones, Professor Robert
• Authors: Baillie, K., Mueller, T., Pan, J., Laskey, J., Bennie, M., Crearie, C., Kavanagh, K., Alvarez‐Madrazo, S., Morrison, D., Clarke, J., Keel, A., Cameron, D., Wu, O., Kurdi, A., and Jones, R. J.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health
• Journal Name: Pharmacoepidemiology and Drug Safety
• Publisher: Wiley
• ISSN: 1053-8569
• ISSN (Online): 1099-1557
• Published Online: 21 April 2020
• Copyright Holders: Copyright © 2020 The Authors
• First Published: First published in Pharmacoepidemiology and Drug Safety 29(6): 653-663
• Publisher Policy: Reproduced under a Creative Commons License