Real-World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men

Clin Pharmacol Ther. 2022 Jan;111(1):302-309. doi: 10.1002/cpt.2454. Epub 2021 Nov 19.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administrative Claims, Healthcare
  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Agents, Hormonal / adverse effects
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Aromatase Inhibitors / adverse effects
  • Aromatase Inhibitors / therapeutic use
  • Breast Neoplasms, Male / drug therapy*
  • Databases, Factual
  • Electronic Health Records
  • Humans
  • Kaplan-Meier Estimate
  • Letrozole / adverse effects
  • Letrozole / therapeutic use
  • Male
  • Middle Aged
  • Neoplasm Metastasis / drug therapy*
  • Observational Studies as Topic
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Pyridines / adverse effects
  • Pyridines / therapeutic use*
  • Retrospective Studies

Substances

  • Antineoplastic Agents
  • Antineoplastic Agents, Hormonal
  • Aromatase Inhibitors
  • Piperazines
  • Pyridines
  • Letrozole
  • palbociclib

Grants and funding