TY - JOUR
T1 - Real-World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men
AU - Kraus, Albert L.
AU - Yu-Kite, Michelle
AU - Mardekian, Jack
AU - Cotter, Matthew J.
AU - Kim, Sindy
AU - Decembrino, Jaclyn
AU - Snow, Tamara
AU - Carson, Kenneth R.
AU - Motyl Rockland, Jillian
AU - Gossai, Anala
AU - Wilner, Keith
AU - Wang, Diane D.
AU - Huang Bartlett, Cynthia
AU - Oharu, Norihiko
AU - Schnell, Patrick
AU - VanArsdale, Todd
AU - Lu, Dongrui R.
AU - Tursi, Jennifer M.
N1 - Funding Information:
Editorial support for development of this manuscript was provided by Anny Wu, PharmD, of ICON (North Wales, PA, USA), and funded by Pfizer Inc. The authors thank Maria Koehler for her contributions to real‐world oncology studies while previously employed at Pfizer Inc.
Publisher Copyright:
© 2021 Pfizer Inc. Clinical Pharmacology & Therapeutics © 2021 American Society for Clinical Pharmacology and Therapeutics
PY - 2022/1
Y1 - 2022/1
N2 - This report examined the benefits and risks of palbociclib plus endocrine therapy (ET) in men with hormone receptor‒positive (HR+)/human epidermal growth factor receptor 2−negative (HER2−) metastatic breast cancer (MBC). Palbociclib was evaluated using three independent data sources: real-world data from pharmacy and medical claims, a de-identified real-world data source derived from electronic health records (EHRs), and a global safety database. From medical and pharmacy records, 1,139 men with MBC were identified; in the first-line setting, median duration of treatment was longer with palbociclib plus ET (n = 37, 8.5 months, 95% confidence interval (CI), 4.4‒13.0) than ET alone (n = 214, 4.3 months, 95% CI, 3.0‒5.7) and specifically, was longer with palbociclib plus letrozole (n = 26, 9.4 months, 95% CI, 4.4‒14.0) than letrozole alone (n = 63, 3.0 months, 95% CI, 1.8‒4.8). In the EHR-derived database, 59 men received treatment for MBC; real-world response across all lines of therapy in the metastatic setting was reported in 4 of 12 patients (33.3%) in the palbociclib plus ET group vs. 1 of 8 (12.5%) patients in the ET group. Review of the global safety database did not identify any new safety signals in palbociclib-treated men. Real-world data indicated that men with MBC benefit from palbociclib plus ET, with a safety profile consistent with previous observations in women with MBC. Collective data on palbociclib in women and men in this report, including clinical trial data, real-world data, and a well-established risk/benefit profile, led to US approval of an expansion of the palbociclib indication to include men with MBC.
AB - This report examined the benefits and risks of palbociclib plus endocrine therapy (ET) in men with hormone receptor‒positive (HR+)/human epidermal growth factor receptor 2−negative (HER2−) metastatic breast cancer (MBC). Palbociclib was evaluated using three independent data sources: real-world data from pharmacy and medical claims, a de-identified real-world data source derived from electronic health records (EHRs), and a global safety database. From medical and pharmacy records, 1,139 men with MBC were identified; in the first-line setting, median duration of treatment was longer with palbociclib plus ET (n = 37, 8.5 months, 95% confidence interval (CI), 4.4‒13.0) than ET alone (n = 214, 4.3 months, 95% CI, 3.0‒5.7) and specifically, was longer with palbociclib plus letrozole (n = 26, 9.4 months, 95% CI, 4.4‒14.0) than letrozole alone (n = 63, 3.0 months, 95% CI, 1.8‒4.8). In the EHR-derived database, 59 men received treatment for MBC; real-world response across all lines of therapy in the metastatic setting was reported in 4 of 12 patients (33.3%) in the palbociclib plus ET group vs. 1 of 8 (12.5%) patients in the ET group. Review of the global safety database did not identify any new safety signals in palbociclib-treated men. Real-world data indicated that men with MBC benefit from palbociclib plus ET, with a safety profile consistent with previous observations in women with MBC. Collective data on palbociclib in women and men in this report, including clinical trial data, real-world data, and a well-established risk/benefit profile, led to US approval of an expansion of the palbociclib indication to include men with MBC.
UR - http://www.scopus.com/inward/record.url?scp=85119376820&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85119376820&partnerID=8YFLogxK
U2 - 10.1002/cpt.2454
DO - 10.1002/cpt.2454
M3 - Article
C2 - 34668577
AN - SCOPUS:85119376820
SN - 0009-9236
VL - 111
SP - 302
EP - 309
JO - Clinical pharmacology and therapeutics
JF - Clinical pharmacology and therapeutics
IS - 1
ER -