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Fulvestrant and palbociclib combination in heavily pretreated hormone receptor-positive, HER2-negative metastatic breast cancer patients

Breast Cancer Research and Treatment volume 179, pages 371–376 (2020)Cite this article

Abstract

Purpose

We report the results of a retrospective analysis of the fulvestrant and palbociclib combination within a temporary authorization of use (TAU) program in 77 heavily pretreated patients with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer.

Methods

All patients who received the fulvestrant and palbociclib combination within this TAU program were included. Toxicities were graded using the CTCAE v5 scale.

Results

The majority of patients (62.3%) were previously treated with the mTOR inhibitor everolimus. The median number of previous treatments for their metastatic disease was 4. With a median follow-up of 14 months, the median progression-free survival (PFS) was 7.6 months. The median PFS significantly (p < 0.0001) decreased with the number of previous treatment lines in the metastatic setting. The median PFS was 5.5 months in patients who had previously progressed on everolimus compared to 9.3 months in the everolimus non-pretreated subgroup. No significant difference in median PFS was detected in patients according to age. The median overall survival rate was not reached. The clinical benefit rate was 64%, including 4% of complete responses, 26% partial responses, and 34% stable diseases for the entire cohort.

Conclusions

The fulvestrant and palbociclib combination exerts an appreciable effect on metastatic heavily pretreated patients with a tolerable toxicity profile.

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Affiliations

  1. Department of Medical Oncology, Centre Paul Strauss, 3, rue de la Porte de l’Hôpital, BP 30042, 67065, Strasbourg, Cedex, France

    Hugo Herrscher, Julie Leblanc, Michal Kalish-Weindling, Cathie Fischbach, Xavier Pivot & Thierry Petit

  2. Department of Epidemiology, Centre Paul Strauss, Strasbourg, France

    Michel Velten

  3. Pharmacy, Centre Paul Strauss, Strasbourg, France

    Delphine Exinger

Authors
  1. Hugo Herrscher
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  2. Michel Velten
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  3. Julie Leblanc
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  4. Michal Kalish-Weindling
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  5. Cathie Fischbach
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  6. Delphine Exinger
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  7. Xavier Pivot
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  8. Thierry Petit
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Contributions

MV and TP: conceived the study. HH and JL: collected and categorized the clinical data. MV, TP and XP: performed the statistical analyses and interpreted the results. HH: drafted the manuscript and all authors critically revised and approved the final manuscript.

Corresponding author

Correspondence to Thierry Petit.

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Conflict of interest

Thierry Petit is member of a Pfizer scientific board.

Ethical approval

The study was approved by the Local Ethical Review Board, and complies with the current laws of France. The study has been performed in accordance with the 1964 Helsinki Declaration and its later amendments. Informed consent was obtained from all individual participants included in the study.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Herrscher, H., Velten, M., Leblanc, J. et al. Fulvestrant and palbociclib combination in heavily pretreated hormone receptor-positive, HER2-negative metastatic breast cancer patients. Breast Cancer Res Treat 179, 371–376 (2020). https://doi.org/10.1007/s10549-019-05439-x

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  • DOI: https://doi.org/10.1007/s10549-019-05439-x

Keywords

  • Endocrine therapy
  • CDK 4/6 inhibitors
  • Advanced breast cancer
  • Fulvestrant
  • Palbociclib