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Lopes Cardozo JMN, Byng D, Drukker CA, et al. Outcome without any adjuvant systemic treatment in stage I ER+/HER2- breast cancer patients included in the MINDACT trial. Ann Oncol. 2021;doi: 10.1016/j.annonc.2021.11.014.
Lopes Cardozo, J. M. N., Byng, D., Drukker, C. A., Schmidt, M. K., Binuya, M. A., van 't Veer, L. J., Cardoso, F., Piccart, M., Smorenburg, C. H., Poncet, C., & Rutgers, E. J. T. (2021). Outcome without any adjuvant systemic treatment in stage I ER+/HER2- breast cancer patients included in the MINDACT trial. Annals of oncology : official journal of the European Society for Medical Oncology, . https://doi.org/10.1016/j.annonc.2021.11.014
Lopes Cardozo, J M N, et al. "Outcome without any adjuvant systemic treatment in stage I ER+/HER2- breast cancer patients included in the MINDACT trial." Annals of oncology : official journal of the European Society for Medical Oncology vol. (2021). doi: https://doi.org/10.1016/j.annonc.2021.11.014
Lopes Cardozo JMN, Byng D, Drukker CA, Schmidt MK, Binuya MA, van 't Veer LJ, Cardoso F, Piccart M, Smorenburg CH, Poncet C, Rutgers EJT. Outcome without any adjuvant systemic treatment in stage I ER+/HER2- breast cancer patients included in the MINDACT trial. Ann Oncol. 2021 Dec 01; doi: 10.1016/j.annonc.2021.11.014. Epub 2021 Dec 01. PMID: 34861376.
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Ann Oncol. 2021 Dec 01; doi: 10.1016/j.annonc.2021.11.014. Epub 2021 Dec 01.

Outcome without any adjuvant systemic treatment in stage I ER+/HER2- breast cancer patients included in the MINDACT trial.

Annals of oncology : official journal of the European Society for Medical Oncology

J M N Lopes Cardozo, D Byng, C A Drukker, M K Schmidt, M A Binuya, L J van 't Veer, F Cardoso, M Piccart, C H Smorenburg, C Poncet, E J T Rutgers

Affiliations

  1. Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands; European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
  2. Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
  3. Department of Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.
  4. Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
  5. Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands; Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
  6. Department of Laboratory Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.
  7. Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.
  8. Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
  9. Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
  10. European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
  11. Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: [email protected].

PMID: 34861376 DOI: 10.1016/j.annonc.2021.11.014

Abstract

BACKGROUND: Adjuvant systemic treatments (AST) reduce mortality, but have associated short- and long-term toxicities. Careful selection of patients likely to benefit from AST is needed. We evaluated outcome of low-risk breast cancer patients of the EORTC 10041/BIG 3-04 MINDACT trial who received no AST.

PATIENTS AND METHODS: Patients with estrogen receptor-positive, HER2-negative, lymph node-negative tumors ≤2 cm who received no AST were matched 1 : 1 to patients with similar tumor characteristics treated with adjuvant endocrine therapy (ET), using propensity score matching and exact matching on age, genomic risk (70-gene signature) and grade. In a post hoc analysis, distant metastasis-free interval (DMFI) and overall survival (OS) were assessed by Kaplan-Meier analysis and hazard ratios (HR) by Cox regression. Cumulative incidences of locoregional recurrence (LRR) and contralateral breast cancer (CBC) were assessed with competing risk analyses.

RESULTS: At 8 years, DMFI rates were 94.8% [95% confidence interval (CI) 92.7% to 96.9%] in 509 patients receiving no AST, and 97.3% (95% CI 95.8% to 98.8%) in 509 matched patients who received only ET [absolute difference: 2.5%, HR 0.56 (95% CI 0.30-1.03)]. No statistically significant difference was seen in 8-year OS rates, 95.4% (95% CI 93.5% to 97.4%) in patients receiving no AST and 95.6% (95% CI 93.8% to 97.5%) in patients receiving only ET [absolute difference: 0.2%, HR 0.86 (95% CI 0.53-1.41)]. Cumulative incidence rates of LRR and CBC were 4.7% (95% CI 3.0% to 7.0%) and 4.6% (95% CI 2.9% to 6.9%) in patients receiving no AST versus 1.4% (95% CI 0.6% to 2.9%) and 1.5% (95% CI 0.6% to 3.1%) in patients receiving only ET.

CONCLUSIONS: In patients with stage I low-risk breast cancer, the effect of ET on DMFI was limited, but overall significantly fewer breast cancer events were observed in patients who received ET, after the relatively short follow-up of 8 years. These benefits and side-effects of ET should be discussed with all patients, even those at a very low risk of distant metastasis.

Copyright © 2021 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

Keywords: breast cancer recurrence; endocrine therapy; low-risk breast cancer; no adjuvant systemic treatment

Conflict of interest statement

Disclosure LJvV reports being shareholder in and part-time employed by Agendia NV, the commercial company that markets the 70-gene signature as MammaPrint. FC has received personal fees from Amgen, As

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