TY - JOUR
T1 - 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
T2 - Updated Analysis with up to 5 Years of Follow-Up
AU - Finn, Richard S.
AU - Rugo, Hope S.
AU - Gelmon, Karen A.
AU - Cristofanilli, Massimo
AU - Colleoni, Marco
AU - Loi, Sherene
AU - Schnell, Patrick
AU - Lu, Dongrui R.
AU - Theall, Kathy Puyana
AU - Mori, Ave
AU - Gauthier, Eric
AU - Bananis, Eustratios
AU - Turner, Nicholas C.
AU - Diéras, Véronique
N1 - Funding Information:
This study was sponsored by Pfizer (Pfizer Inc.; NCT00721409, NCT01740427, NCT01942135). Editorial support was provided by Anny Wu, Pharm.D., of ICON plc (North Wales, PA) and was funded by Pfizer.
Publisher Copyright:
© 2021 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press.
PY - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
KW - Advanced breast cancer
KW - HR+/HER2−
KW - Long-term safety
KW - Palbociclib
KW - Pooled safety
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UR - http://www.scopus.com/inward/citedby.url?scp=85102454338&partnerID=8YFLogxK
U2 - 10.1002/onco.13684
DO - 10.1002/onco.13684
M3 - Article
C2 - 33486783
AN - SCOPUS:85102454338
VL - 26
SP - e749-e755
JO - Oncologist
JF - Oncologist
SN - 1083-7159
IS - 5
ER -