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

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 (mCRPC), 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 02.2012 to 02.2017). 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, 200 (73.8%) of which died during the study period. Median OS was poorer than in the pivotal trials, regardless of medication and indication: 10.8 months (95% 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 (NR)) 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 (PSA), alkaline phosphatase, and albumin levels. Conclusions Poorer prognostic features of non-trial eligible patients impact real-world outcomes of cancer medicines. ERL 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 policy makers to contextualise trial findings.