Ketoconazole results in biochemical and hormonal improvement for most patients with ECS. It has few adverse effects, but may impair the cortisol response to stress. For that reason, replacement corticosteroids should be considered for patients with hormonal response, and moderate- to high-dose corticosteroids should be given for any potential stress situations. The ultimate control of the syndrome is dependent on successful treatment of the underlying tumor.
Docetaxel chemotherapy in hormone-naïve mPC has significant toxicities, but has a similar effect on time to progression and overall survival as seen in randomised trials. Chemotherapy should be started at ≥3 weeks after ADT.
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.
Objective
To identify what matters to clinicians and patients when discussing cancer medicines’ impact on health-related quality of life (HRQoL).
Methods
A framework of HRQoL domain/domain elements was developed, informed by analysis of published patient reported outcome measures (PROMs), applicable to prostate cancer. Using mixed methods (eDelphi, Nominal Group Technique and questionnaire), prostate cancer clinicians and patients attending prostate cancer clinics and support groups were asked which domains/domain elements would be important to them when discussing the impact prostate cancer medicines have on their HRQoL.
Results
Twenty-one clinicians and 71 patients participated from the West of Scotland. Clinicians and patients identified 53/62 domain elements across seven domains as important, of which 32 (60%) were common to both groups. Clinicians placed more importance than patients on Mood & Emotion; in contrast, patients placed importance on a broader range of Symptoms & Side Effects, being informed about their care, and having effective healthcare professional collaboration.
Conclusion
This study provides insight into the similarities and differences between what clinicians and patients think is important when discussing the impact of cancer medicines on HRQoL. Future research should involve exploring the potential for consistency of medicines PROMs across different cancer types to support patient-clinician communication and drive improvements in care.
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.
Objectives: To discuss the opportunities and challenges when applying an electronic record linkage methodology with respect to systemic anti-cancer therapy, and to highlight some of the potential pitfalls spanning the entire breadth and depth of the research process.
Design: Retrospective cohort studies using routinely collected, administrative health data.
Setting: Scotland
Results: Studies conducted to-date have indicated that record linkage of routinely collected data to determine outcomes of treatment with cancer medicines is feasible, albeit currently within certain limits. While the general description of patient populations and the calculation of median overall survival are well supported, prevailing issues with combining data across regional boundaries and the limited availability of some variables (including molecular pathology data and information regarding toxicities) may restrict the extent of analyses feasible.
Conclusion: There is scope to conduct large cohort studies to generate results from clinical practice using linkage of routinely collected health care data within a reasonable time frame; however, close collaboration between researchers, data controllers, and clinicians is required in order to obtain valid and meaningful results.
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