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Real-world data on neoadjuvant endocrine therapy in ER-positive/HER2-negative breast cancer

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Abstract

Purpose

Neoadjuvant endocrine therapy (NET) has been shown to be effective in ER-positive/HER2-negative breast cancer in clinical trials. However, adoption in clinical practice is still limited. Real-world data may provide useful insights into effectiveness, toxicities and quality of care, potentially rendering clinical trial results to the real-world setting. Our purpose was to report real-world data of a cohort of postmenopausal patients submitted to NET.

Methods

This prospective cohort study evaluated 146 postmenopausal female patients with ER-positive/HER2-negative breast cancer treated with NET at three tertiary hospitals between 2016 and 2018. Clinicopathological information were collected prospectively. Preoperative Endocrine Prognostic Index (PEPI) score was calculated for tumors submitted to at least 16 weeks of NET.

Results

Median age was 67 years old, and 87.8% had stage I-II disease. Most tumors had histological grade II (76.1%). Median pretreatment Ki67 expression was 10%. Aromatase inhibitor was used in 99.5% of patients, and median treatment duration was 21.0 weeks. No tumor progressed during NET. Breast-conserving surgery was performed in the majority of patients (63.0%), as well as sentinel lymph-node biopsy (76.7%). Pathological complete response rate was 1.0%. 43 patients (29.5%) had PEPI score 0, and 26% had PEPI scores 4–5. Posttreatment Ki67 median expression was 3.0%, and only five tumors (3.4%) showed marked increase in Ki67 expression during treatment. Seven patients (4.8%) had HER2-positive residual disease, and were treated with adjuvant chemotherapy plus trastuzumab.

Conclusions

Our real-world data shows that NET is effective and safe in postmenopausal patients with ER-positive/HER2-negative breast cancer. Postmenopausal status and low-risk luminal tumor features (luminal A-like) should be used as selection criteria to ensure the best results with NET.

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Data availability

All the authors had full access to all the data in the study and vouch for the decision to submit the manuscript for publication.

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Funding

Silva LR—Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)—Brasil Finance Code 001. The funding sources did not have any direct involvement on the collection, analysis, and interpretation of the data, nor did they were involved on the writing and revision of the manuscript.

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Authors and Affiliations

  1. Faculty of Medical Sciences, Department of Obstetrics and Gynecology, State University of Campinas (UNICAMP), R Alexander Fleming 101—Cidade Universitária “Zeferino Vaz”, Campinas, SP, 13083-881, Brazil

    Leonardo Roberto da Silva, Camila Annicchino de Andrade, Fabrício Brenelli, Susana Ramalho, Ana Elisa Ribeiro da Silva, Maria Beatriz de Paula Leite Kraft, Vivian Castro Antunes de Vasconcelos, Renato Zochio Torresan, Cesar Cabello & Luiz Carlos Zeferino

  2. Centro de Pesquisa da Serra Gaúcha (CEPESG), Caxias do Sul, Brazil

    Tomás Reinert

  3. Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil

    Tomás Reinert

  4. Breast Cancer Center, Hospital São Lucas, Pontifical Catholic University of Rio Grande Do Sul (PUCRS), Porto Alegre, Brazil

    Alessandra Borba Anton de Souza & Antônio Luiz Frasson

  5. Lester and Sue Smith Breast Cancer Center, Baylor College of Medicine, Houston, TX, USA

    Matthew J. Ellis

Authors
  1. Leonardo Roberto da Silva
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  7. Ana Elisa Ribeiro da Silva
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  11. Renato Zochio Torresan
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  12. Cesar Cabello
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  14. Luiz Carlos Zeferino
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Contributions

All authors contributed to the study conception and design. Material preparation and data collection were performed by LRS, CAA, SR, TR, ABAS, AERS, MBPLK, VCAV. Analysis was performed by LRS, CAA, FB, SR. The first draft of the manuscript was written by LRS, CAA, FB, SR. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Luiz Carlos Zeferino.

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The authors have no conflicts of interest to declare that are relevant to the content of this article.

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Leonardo Roberto da Silva and Camila Annicchino de Andrade are co-first authors.

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da Silva, L.R., de Andrade, C.A., Brenelli, F. et al. Real-world data on neoadjuvant endocrine therapy in ER-positive/HER2-negative breast cancer. Breast Cancer Res Treat 186, 753–760 (2021). https://doi.org/10.1007/s10549-020-06076-5

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  • DOI: https://doi.org/10.1007/s10549-020-06076-5

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