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Clinical Studies

Rethinking surgical revisions: impact of the MonarchE trial on axillary dissection in hormone-positive HER2-negative early breast cancer patients potentially eligible for abemaciclib

British Journal of Cancer volume 130, pages 1141–1148 (2024)Cite this article

Subjects

Abstract

Introduction

The MonarchE trial explored the use of abemaciclib, a CDK4/6 inhibitor, as an adjuvant treatment in high-risk early-stage luminal-like breast cancer. The study’s inclusion criteria, especially the N2 status, may require revisiting surgical interventions, including invasive axillary lymph node dissection (ALND)—a procedure that current guidelines generally do not recommend.

Methods

We conducted a single-centre, retrospective, observational cohort study on non-metastatic breast cancer patients managed from 2002 to 2011, at the Institut Curie. Data collection involved clinical and histological characteristics plus treatment follow-up.

Results

Out of 8715 treated patients, 721 met the inclusion criteria. Overall, 12% (87) were classified as N2 ( ≥ 4 positive lymph nodes), thus eligible for abemaciclib per “node criterion.” Tumour size, positive sentinel lymph nodes, and lobular histology showed a significant correlation with N2 status. Approximately 1000 ALNDs would be required to identify 120 N2 cases and prevent four recurrences.

Conclusion

The MonarchE trial may significantly affect surgical practices due to the need for invasive procedures to identify high-risk patients for adjuvant abemaciclib treatment. The prospect of unnecessary morbidity demands less invasive N2 status determination methods. Surgical decisions must consider patient health and potential treatment benefits.

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Fig. 1: Flow chart.
Fig. 2: Percentage of N2 status according to the ratio of positive/removed SLNs to the total of SLN removed.
Fig. 3: Proportion of avoided recurrences among axillary dissection.
Fig. 4: Sunburst representing the part of patients with MonarchE “node criterion” of surgical revision among the whole database.

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Data availability

Not applicable.

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Authors and Affiliations

  1. Department of Breast and Gynecological Surgery, Institut Curie, Université Paris Cité, Paris, France

    Thomas Gaillard, Jeanne Piketty, Jean-Guillaume Feron, Noemie Girard, Lea Pauly, Elodie Gauroy, Lauren Darrigues, Beatriz Grandal, Fabien Reyal & Enora Laas

  2. Residual Tumor & Response to Treatment Laboratory, RT2Lab, Translational Research Department, INSERM, U932 Immunity and Cancer, Paris, France

    Beatriz Grandal, Jean-Yves Pierga, Anne-Sophie Hamy-Petit & Fabien Reyal

  3. Department of Medical Oncology, Institut Curie, Université Paris Cité, Paris, France

    Jean-Yves Pierga & Anne-Sophie Hamy-Petit

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Contributions

Conceptualisation: TG and EL. Methodology: TG and EL. Formal analysis: TG and EL. Writing—original draft: TG. Writing review and editing: TG, JP, J-GF, NG, LP, EG, LD, BG, J-YP, A-SH-P, FR and EL. Supervision: EL. All authors discussed the results and contributed to the final manuscript.

Corresponding author

Correspondence to Thomas Gaillard.

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The study was approved by the Institutional Review Board of the Institut Curie and conducted in accordance with institutional and ethical rules regarding research on tissue samples and patients. All patients gave their initial consent to the use of their anonymized data.

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Gaillard, T., Piketty, J., Feron, JG. et al. Rethinking surgical revisions: impact of the MonarchE trial on axillary dissection in hormone-positive HER2-negative early breast cancer patients potentially eligible for abemaciclib. Br J Cancer 130, 1141–1148 (2024). https://doi.org/10.1038/s41416-024-02580-3

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