Patients treated in real-world settings may have different demographic and health conditions than those enrolled in randomized controlled trials, which can make it difficult to understand how well trial findings apply in routine care. This study used real-world data (RWD) to explore whether the MONALEESA-2 trial’s results could be emulated and what broader eligibility might mean for interpreting overall survival.
The study attempted to emulate the MONALEESA-2 randomized controlled trial using real-world data on women with advanced HR-positive, HER2-negative breast cancer treated with ribociclib plus letrozole. Only a small proportion of real-world patients met all trial inclusion and exclusion criteria along with a baseline observability requirement, and those who did differed from trial participants in age and patterns of metastatic disease. The researchers also observed substantial differences between women receiving ribociclib plus letrozole and those treated with letrozole alone in the real world, which prevented replication of the trial’s overall survival results. The findings illustrate the challenges of trial emulation in real-world data, including population differences, data source limitations, and design constraints.
Find the full study here.