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Purpose <p>Cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) combined with endocrine therapy is the recommended first-line (1L) treatment for hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). Real-world evidence (RWE) describing 1L CDK4/6i regimens and associated clinical outcomes in Europe is limited. The study objective was to describe clinical characteristics, tumor response, and survival outcomes in patients with HR+/HER2− ABC.</p> Methods <p>This retrospective, observational cohort study used data from 52 treatment centers in the UK, Spain, and Germany and included patients who initiated 1L palbociclib + aromatase inhibitor (AI) therapy for ABC between 2016 and 2020. Primary endpoints were real-world progression-free survival (rwPFS) and overall survival (OS).</p> Results <p>Data were abstracted from 856 patients. During treatment, complete response, partial response, or stable disease was achieved for 86.1% of patients in Spain, 80.7% in the UK, and 79.0% in Germany, while complete or partial response was achieved for 43.8% of patients in Spain, 34.9% in the UK, and 16.9% in Germany. Median rwPFS during treatment was 28.1&#xa0;months for patients in Spain, 33.9&#xa0;months in the UK, and 48.1&#xa0;months in Germany. Median OS was 51.3&#xa0;months (95% CI 46.6–NE) in the UK, 65.2&#xa0;months (95% CI 65.2–NE) in Germany, and not reached in Spain.</p> Conclusion <p>This RWE supports the clinical effectiveness of 1L palbociclib + AI in routine clinical practice in European countries—consistent with the efficacy observed in clinical trials—and further supports the implementation of palbociclib-based regimens as frontline treatment of HR+/HER2− ABC.</p>

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Real-world clinical outcomes associated with first-line palbociclib and aromatase inhibitor therapy among patients with HR+/HER2− advanced breast cancer in Europe

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月6日

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  • Olga Oikonomidou,
  • Mark J. Beresford,
  • Elena Galve-Calvo,
  • Achim Woeckel,
  • Rohan C. Parikh,
  • Abigail Hitchens,
  • Connie Chen,
  • Justin Doan,
  • Benjamin Li,
  • Valerie Derrien Ansquer,
  • Gaelle Frugier,
  • Maria I. Jimenez,
  • Keith L. Davis,
  • Edward I. Broughton

摘要

Purpose

Cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) combined with endocrine therapy is the recommended first-line (1L) treatment for hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). Real-world evidence (RWE) describing 1L CDK4/6i regimens and associated clinical outcomes in Europe is limited. The study objective was to describe clinical characteristics, tumor response, and survival outcomes in patients with HR+/HER2− ABC.

Methods

This retrospective, observational cohort study used data from 52 treatment centers in the UK, Spain, and Germany and included patients who initiated 1L palbociclib + aromatase inhibitor (AI) therapy for ABC between 2016 and 2020. Primary endpoints were real-world progression-free survival (rwPFS) and overall survival (OS).

Results

Data were abstracted from 856 patients. During treatment, complete response, partial response, or stable disease was achieved for 86.1% of patients in Spain, 80.7% in the UK, and 79.0% in Germany, while complete or partial response was achieved for 43.8% of patients in Spain, 34.9% in the UK, and 16.9% in Germany. Median rwPFS during treatment was 28.1 months for patients in Spain, 33.9 months in the UK, and 48.1 months in Germany. Median OS was 51.3 months (95% CI 46.6–NE) in the UK, 65.2 months (95% CI 65.2–NE) in Germany, and not reached in Spain.

Conclusion

This RWE supports the clinical effectiveness of 1L palbociclib + AI in routine clinical practice in European countries—consistent with the efficacy observed in clinical trials—and further supports the implementation of palbociclib-based regimens as frontline treatment of HR+/HER2− ABC.