P-REALITY X: A Real-World Analysis of Palbociclib Plus an Aromatase Inhibitor in HR+/HER2− Metastatic Breast Cancer—A Podcast

Abstract

Stringent enrollment criteria can limit the diversity of patient populations in clinical trials and, consequently, the generalizability of clinical trial data to real-world clinical practice. In this podcast, we discuss how real-world data in heterogeneous patient populations can complement clinical trial data in informing treatment decision making for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) metastatic breast cancer. Specifically, our focus is on P-REALITY X, an observational retrospective analysis that was recently published in npj Breast Cancer. P-REALITY X used real-world data from the Flatiron database to compare the effectiveness of palbociclib plus an aromatase inhibitor versus an aromatase inhibitor alone as first-line treatment for patients with HR+/HER2− metastatic breast cancer. After stabilized inverse probability treatment weighting to control for observed confounders, both overall survival and real-world progression-free survival were significantly prolonged with palbociclib plus an aromatase inhibitor versus an aromatase inhibitor alone. Furthermore, overall survival and real-world progression-free survival benefits were observed across most subgroups examined. We discuss the clinical implications of P-REALITY X data, including how these results add to data from prior randomized clinical trials and real-world studies in supporting the use of first-line palbociclib plus an aromatase inhibitor as a standard-of-care treatment for patients with HR+/HER2− metastatic breast cancer. We also provide an example of how to integrate and describe key information about the P-REALITY X study in plain language when discussing palbociclib as a therapeutic option with patients.