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

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...

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Detalles Bibliográficos
Autores principales: Brufsky, Adam, Gallagher, Christopher
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10192186/
https://www.ncbi.nlm.nih.gov/pubmed/37148492
http://dx.doi.org/10.1007/s11523-023-00968-4
Descripción
Sumario: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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11523-023-00968-4.