Real-world effectiveness of systemic anticancer therapy for advanced melanoma in the west of Scotland from 2010 to 2018.

Aim: Assess the real-world effectiveness of systemic anticancer therapy in advanced (unresectable or metastatic) melanoma. Methods: This was a retrospective cohort study linking routine healthcare data with systemic anticancer therapy prescriptions for patients starting immunotherapy or targeted treatments between 1 November 2010 and 31 December 2017 in the west of Scotland. Results: Among 362 patients identified, median overall survival varied between 18.5 months (95% CI: 14.4-not estimable) for ipilimumab/nivolumab combination and 5.6 months (95% CI: 4.5-7.3) for dabrafenib, but there were differences in the characteristics of each regimen cohort. Raised lactate dehydrogenase levels and Eastern Cooperative Oncology Group performance status ≥2 negatively impacted overall survival. Conclusion: The patients had a shorter median overall survival than those in pivotal trials. This was expected, given that this real-world cohort included patients with poorer prognostic indicators, typically excluded from trials.

The impact of COVID-19 on systemic anticancer treatment delivery in Scotland.

Understanding the impact of the COVID-19 pandemic on systemic anticancer therapy delivery (SACT) is crucial to appreciate the short- and long-term consequences for cancer patients and plan future care. Here, we report real-time national SACT delivery data from NHS Scotland. We demonstrate an initial rapid reduction in patient attendance of 28.7% with subsequent rapid recovery following service redesign. The smallest decrease was seen in breast cancer (19.7%), which also had the most rapid recovery and the largest decrease seen in colorectal cancer (43.4%). Regional variation in the magnitude of impact on SACT delivery was observed, but nadirs occurred at the same time and the rate of recovery was similar across all regions. This recovery reflected a coordinated national approach and associated patient and clinician support structures, which facilitated the creation of COVID-19-protected areas for SACT delivery in Scottish cancer centres enabling rapid sharing of successful and innovative strategies. The data show that these actions have limited the disadvantage to cancer patients.

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, 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.

Opportunities and challenges when using record linkage of routinely collected electronic health care data to evaluate outcomes of systemic anti-cancer treatment in clinical practice.

The efficacy and safety of cancer medicines as reported from randomised clinical trials do not always translate into similar benefits in routine clinical practice; hence, post-marketing studies are a useful addition to the evidence base. With recent advances in digital infrastructure and the advent of electronically available health records, linkage of routinely collected data has emerged as a promising evaluation method for these studies. This paper discusses the opportunities and challenges when applying an electronic record linkage methodology with respect to systemic anti-cancer therapy by showcasing exemplar studies conducted over a three-year period in Scotland, and highlights some of the potential pitfalls spanning the entire breadth and depth of the research process. Our experiences as an interdisciplinary team indicate that there is scope to conduct large cohort studies to generate results from routine clinical practice within a reasonable time frame; however, close collaboration between researchers, data controllers and clinicians is required in order to obtain valid and meaningful results.