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

The oncologist

article

Richard S. Finn¹  Ave Mori²  Eric Gauthier³  Eustratios Bananis³  Nicholas C. Turner⁴  Véronique Diéras⁵  Hope S. Rugo⁶  Karen A. Gelmon⁷  Massimo Cristofanilli⁸  Marco Colleoni⁹  Sherene Loi^1,10  Patrick Schnell³  Dongrui R. Lu³  Kathy Puyana Theall^1,11 

[1] David Geffen School of Medicine at the University of California Los Angeles;Pfizer S.r.l.;Pfizer Inc.;Royal Marsden Hospital and Institute of Cancer Research, United Kingdom;Centre Eugène Marquis;University of California San Francisco Comprehensive Cancer Center;British Columbia Cancer Agency;Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine;IEO European Institute of Oncology;Peter MacCallum Cancer Centre, University of Melbourne;Pfizer Oncology

关键词: Long-term safety;    Pooled safety;    Palbociclib;    Advanced breast cancer;    HR+/HER2−;   

DOI  :  10.1002/onco.13684

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

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 neutropenia. Febrile neutropenia was reported in 1.4% of patients receiving palbociclib plus ET. Cumulative incidence of all-grade hematologic adverse events in both arms peaked during the first year of treatment and plateaued over the 5 subsequent years. Interstitial lung disease was reported in 13 patients receiving palbociclib plus ET and 3 receiving ET. Conclusion This 5-year, long-term analysis demonstrated that palbociclib plus ET has a consistent and stable safety profile and is a safe treatment for patients with HR+/HER2− ABC. Implications for Practice Several treatments for patients with breast cancer are associated with long-term or latent adverse events. This long-term, 5-year analysis demonstrated that palbociclib plus endocrine therapy has a consistent and stable safety profile without cumulative or delayed toxicities. These results further support palbociclib plus endocrine therapy as a safe and manageable treatment in clinical practice for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.

【 授权许可】

CC BY|CC BY-NC