Outcomes Management in a Real-World Evidence Context: The Case of Abiraterone and Enzalutamide in the Treatment of Metastatic Castration-Resistant Prostate Cancer

Abstract

ABSTRACT At present, for patients with metastatic and castration-resistant prostate cancer, European Society for Medical Oncology and National Comprehensive Cancer Network guidelines recommend enzalutamide (E) or abiraterone (A). There are still a few studies comparing both drugs in a real-world setting, thus, in this article, we discuss an outcomes management methodology, supporting the follow-up of patients. This involves measuring relevant baseline traits and outcomes, such as overall survival (OS), treatment duration, patient-reported outcomes, and adverse events. We include 38 men in the A group and 15 in the E group. When comparing the survival of both drugs, both present similar OS. Regarding the quality-of-life analysis (QoL) with EPIC26, reported Standard QoL score was 58.3% in our patients, which was in line with the European Organization for the Research and Treatment of Cancer reference. As a result, by showing that we can capture the distinctive clinical benefits of A and E, and that patient-reported outcomes can be systematically collected for more than 2 years per living patient, we can now incorporate these findings in clinical discussions, risk-sharing agreements, or policy-level arguments.