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Long‐Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor‐Positive/Human Epidermal Growth Factor Receptor 2‐Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow‐Up by Richard S. Finn; Hope S. Rugo; Karen A. Gelmon; Massimo Cristofanilli; Marco Colleoni; Sherene Loi; Patrick Schnell; Dongrui R. Lu; Kathy Puyana Theall; Ave Mori; Eric Gauthier; Eustratios Bananis; Nicholas C. Turner; Véronique Diéras is a Medicine article available to read on EtoBox.

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## Abstract ## Background Previous studies demonstrated the tolerability of palbociclib plus endocrine therapy (ET). This analysis evaluated safety based on more recent cutoff dates and a longer palbociclib treatment exposure. ## Patients and Methods Data were pooled from three randomized studies of patients with hormone receptor‐positive/human epidermal growth factor receptor 2‐negative (HR+/HER2−) advanced breast cancer (ABC), including postmenopausal women who had not received prior systemic treatment for advanced disease (PALOMA‐1/‐2) and pre‐ and postmenopausal women who had progressed on prior ET (PALOMA‐3). ## Results Updated cutoff dates were December 21, 2017 (PALOMA‐1), May 31, 2017 (PALOMA‐2), and April 13, 2018 (PALOMA‐3). Total person‐years of treatment exposure were 1,421.6 with palbociclib plus ET (__n__ = 872) and 528.4 with ET (__n__ = 471). Any‐grade neutropenia and infections were more frequent with palbociclib plus ET (82.1% and 59.2%, respectively) than with ET (5.1% and 39.5%). The hazard ratios were 1.6 (__p__ = .0995) for grade 3/4 infections, 1.8 (__p__ = .4358) for grade 3/4 viral infections, 1.4 (__p__ = .0001) for infections, and 30.8 (__p__ < .0001) for

Who reads Long‐Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor‐Positive/Human Epidermal Growth Factor Receptor 2‐Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow‐Up?

Author

Richard S. Finn; Hope S. Rugo; Karen A. Gelmon; Massimo Cristofanilli; Marco Colleoni; Sherene Loi; Patrick Schnell; Dongrui R. Lu; Kathy Puyana Theall; Ave Mori; Eric Gauthier; Eustratios Bananis; Nicholas C. Turner; Véronique Diéras

Publisher

Wiley

Published

2021

Language

EN

Field

Medicine (Health Sciences)