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First-line therapy with palbociclib in patients with advanced HR+/HER2− breast cancer: The real-life study PALBOSPAIN

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2024年4月1日

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  • N. Martínez-Jañez,
  • M. Bellet Ezquerra,
  • L. M. Manso Sanchez,
  • F. Henao Carrasco,
  • A. Anton Torres,
  • S. Morales,
  • P. Tolosa Ortega,
  • V. L. Obadia Gil,
  • T. Sampedro,
  • R. Andrés Conejero,
  • L. Calvo-Martinez,
  • E. Galve-Calvo,
  • R. López,
  • F. Ayala de la Pena,
  • S. Lopez-Tarruella,
  • B. A. Hernando Fernandez de Araguiz,
  • L. Boronat Ruiz,
  • T. Martos Cardenas,
  • J. I. Chacon,
  • F. Moreno Antón

摘要

Purpose

To evaluate the efficacy and safety of first-line therapy with palbociclib in a Spanish cohort treated after palbociclib approval.

Methods

PALBOSPAIN is an observational, retrospective, multicenter study evaluating real-world patterns and outcomes with 1 L palbociclib in men and women (any menopausal status) with advanced HR+/HER2– BC diagnosed between November 2017 and November 2019. The primary endpoint was real-world progression-free survival (rw-PFS). Secondary endpoints included overall survival (OS), the real-world response rate (rw-RR), the clinical benefit rate, palbociclib dose reduction, and safety.

Results

A total of 762 patients were included. The median rw-PFS and OS were 24 months (95% CI 21–27) and 42 months (40-not estimable [NE]) in the whole population, respectively. By cohort, the median rw-PFS and OS were as follows: 28 (95% CI 23–39) and 44 (95% CI 38-NE) months in patients with de novo metastatic disease, 13 (95% CI 11–17) and 36 months (95% CI 31–41) in patients who experienced relapse < 12 months after the end of ET, and 31 months (95% CI 26–37) and not reached (NR) in patients who experienced relapse > 12 months after the end of ET. rw-PFS and OS were longer in patients with oligometastasis and only one metastatic site and those with non-visceral disease. The most frequent hematologic toxicity was neutropenia (72%; grade ≥ 3: 52.5%), and the most common non-hematologic adverse event was asthenia (38%).

Conclusion

These findings, consistent with those from clinical trials, support use of palbociclib plus ET as 1 L for advanced BC in the real-world setting, including pre-menopausal women and men.

Trial registration number

NCT04874025 (PALBOSPAIN). Date of registration: 04/30/2021 retrospectively registered.