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Objectives <p>To evaluate the clinical benefit of the vinorelbine–gemcitabine every two weeks (VNR-GEMQ2W) regimen in patients with hormone receptor-positive (HR +)/HER2- advanced breast cancer (ABC) treated at a tertiary care hospital and with previous progression on cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i).</p> Study design <p>A retrospective analysis was conducted on women treated for HR + /HER2—ABC, with VNR 25&#xa0;mg/m<sup>2</sup> and GEM 1000&#xa0;mg/m<sup>2</sup> administered every two weeks between 2019 and 2024 at a single hospital.</p> <p>Main outcome measures. Progression-free survival (PFS), overall response rate (ORR), overall survival, and treatment-related adverse events (AEs) evaluated according to CTCAE version 5.0 were retrospectively analyzed. A subanalysis of the data was performed based on major prognostic factors.</p> Results <p>A total of 53 patients were included, with a median age of 56.70&#xa0;years. The majority had visceral metastases (81.13%). Patients had received a median of three prior lines of therapy – two lines of endocrine therapy and one line of chemotherapy. The median follow-up time was 28&#xa0;months [interquartile range 15–34]. The median PFS was 4.27&#xa0;months (95% confidence interval 3.25–6.34), and ORR was 18.87%. Grade ≥ 3 neutropenia was the most frequent severe AE (10.77%), with no treatment discontinuations due to toxicity. Only one case of grade 2 alopecia was reported (1.88%).</p> Conclusions <p>Administering after CDK4/6i and capecitabine, VNR-GEMQ2W regimen shows activity in HR + /HER2- ABC and a manageable safety profile. This regimen should be considered as a potential control arm in the design of future clinical trials targeting HR + /HER2- ABC.</p>

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Antitumor activity of the combination of vinorelbine and gemcitabine in patients with HR + /HER2- advanced breast cancer after CDK4/6 inhibitor

  • 期刊论文

  • 发表日期：

    2025年12月5日

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  • Pablo Jara,
  • Marc Ariant,
  • Roberto Jiménez,
  • Marianela Bringas,
  • Blanca Herrero,
  • Isabel Echavarría,
  • Yolanda Jerez,
  • Sara López-Tarruella,
  • Iván Márquez-Rodas,
  • María del Monte-Millán,
  • Tatiana Massarrah,
  • Francisco Ayala de la Peña,
  • Miguel Martín

摘要

Objectives

To evaluate the clinical benefit of the vinorelbine–gemcitabine every two weeks (VNR-GEMQ2W) regimen in patients with hormone receptor-positive (HR +)/HER2- advanced breast cancer (ABC) treated at a tertiary care hospital and with previous progression on cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i).

Study design

A retrospective analysis was conducted on women treated for HR + /HER2—ABC, with VNR 25 mg/m2 and GEM 1000 mg/m2 administered every two weeks between 2019 and 2024 at a single hospital.

Main outcome measures. Progression-free survival (PFS), overall response rate (ORR), overall survival, and treatment-related adverse events (AEs) evaluated according to CTCAE version 5.0 were retrospectively analyzed. A subanalysis of the data was performed based on major prognostic factors.

Results

A total of 53 patients were included, with a median age of 56.70 years. The majority had visceral metastases (81.13%). Patients had received a median of three prior lines of therapy – two lines of endocrine therapy and one line of chemotherapy. The median follow-up time was 28 months [interquartile range 15–34]. The median PFS was 4.27 months (95% confidence interval 3.25–6.34), and ORR was 18.87%. Grade ≥ 3 neutropenia was the most frequent severe AE (10.77%), with no treatment discontinuations due to toxicity. Only one case of grade 2 alopecia was reported (1.88%).

Conclusions

Administering after CDK4/6i and capecitabine, VNR-GEMQ2W regimen shows activity in HR + /HER2- ABC and a manageable safety profile. This regimen should be considered as a potential control arm in the design of future clinical trials targeting HR + /HER2- ABC.