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Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients

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Abstract

Purpose

Inferior overall response rate with abemaciclib plus endocrine therapy was observed in patients with hormone receptor-positive/HER2-negative advanced breast cancer (BC) and BMI ≥ 25. We assessed the impact of baseline BMI on KI67% changes, achievement of complete cell cycle arrest (CCCA), clinical, and radiological responses in patients included in the NEOMONARCH trial.

Methods

Exploratory post hoc analysis of the NEOMONARCH trial was performed. Patients were classified according to baseline BMI into underweight/normal weight (BMI < 25 kg/m2) and overweight/obese (BMI ≥ 25 kg/m2).

Results

222 patients (84.4%) had baseline BMI information available. In the overall cohort, mean Ki67% changes at 2 weeks were similar between the two BMI groups: − 19 (IQR − 27.8 to − 10.4) for patients with BMI < 25 and − 17.2 (IQR − 26.8 to − 11) for patients with BMI ≥ 25 (p = 0.760). There was no statistical difference in patients achieving CCCA after 2 weeks of treatment according to BMI (p = 0.096). Mean Ki67% reduction at 2 weeks was significantly higher for patients receiving abemaciclib plus anastrozole when compared to either anastrozole or abemaciclib alone, regardless of BMI. At the end of treatment, there was no significant difference regarding radiological (p = 0.366) or clinical response (p = 0.261).

Conclusion

BMI categorized by the threshold of 25 did not significantly impact KI67% changes or clinical and radiological response. Although limited by the small sample size, these results are reassuring that the combination of abemaciclib plus anastrazole appears to be active in the early setting regardless of baseline BMI.

Trial registration: ClinicalTrials.gov identifier: NCT02441946.

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Acknowledgements

This manuscript is based on research using data from Lilly that has been made available through Vivli, Inc. Vivli has not contributed to or approved and is not in any way responsible for the contents of this publication.

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Author notes

  1. Maria Alice Franzoi

    Present address: Gustave Roussy Institute, Villejuif, France

Authors and Affiliations

  1. Clinical Trials Support Unit and Academic Trials Promoting Team, Institut Jules Bordet and L’Université Libre de Bruxelles (U.L.B), Brussels, Belgium

    Maria Alice Franzoi & Evandro de Azambuja

  2. Department of Medical Oncology, IRCCS Ospedale Policlinico San Martino, Genoa, Italy

    Matteo Lambertini

  3. Department of Internal Medicine and Medical Specialies (DiMI), School of Medicine, University of Genova, Genoa, Italy

    Matteo Lambertini

  4. Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy

    Marcello Ceppi & Marco Bruzzone

  5. Breast Cancer Survivorship Research Program, Gustave Roussy - Inserm Unit 981, Villejuif, France

    Maria Alice Franzoi

Authors
  1. Maria Alice Franzoi
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Corresponding author

Correspondence to Maria Alice Franzoi.

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Conflict of interest

M. Franzoi had none. M. Lambertini received consulting fees (e.g. advisory boards) and was a consultant or played an advisory role for Roche, Novartis, Lilly, and AstraZeneca. Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g. speakers’ bureaus); Speakers’ Bureau: Theramex, Takeda, Roche, Lilly, Novartis, Pfizer, and Sandoz. M. Ceppi had none. M. Bruzzone had none. E. de Azambuja received consulting fees (e.g. advisory boards) from Roche/Genentech, Novartis, Libbs, Pierre Fabre, and Lilly. Other author received honoraria from Roche/Genentech, SeaGen, and Zodiac Pharma, travel, accommodations, and expenses from Roche/Genentech, GlaxoSmithKline, and research funding from Roche/Genentech, AstraZeneca, Servier/Pfizer, and GlaxoSmithKline/Novartis.

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Franzoi, M.A., Lambertini, M., Ceppi, M. et al. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat 192, 457–462 (2022). https://doi.org/10.1007/s10549-022-06525-3

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  • DOI: https://doi.org/10.1007/s10549-022-06525-3

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