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Benefit of adjuvant chemotherapy and trastuzumab in patients with HER2-positive, node-negative breast tumors ≤ 10 mm: a nationwide study

  • Epidemiology
  • Published:
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Abstract

Purpose

The purpose of this study was to evaluate the effect of chemotherapy and trastuzumab on invasive disease-free survival (iDFS) and overall survival (OS) in patients with human epidermal growth factor receptor 2 (HER2) positive, T1abN0 breast cancer.

Methods

In the Danish Breast Cancer Group database, patients with HER2-positive, T1abN0 tumors diagnosed between 2007 and 2016 were identified. Cox proportional hazards analysis was performed to analyze the association between adjuvant chemotherapy and trastuzumab and iDFS and OS.

Results

Of 605 patients included in the analyses, 465 patients received chemotherapy and trastuzumab and 140 patients did not. Chemotherapy and trastuzumab did not improve iDFS or OS significantly in adjusted analyses. 5-year iDFS was 92.3% vs. 89.9%, Hazard ratio (HR) 1.01 (p = 0.98), and 5-year OS was 97.4% vs. 94.3%, HR 0.60 (p = 0.15), chemotherapy and trastuzumab vs. no chemotherapy/trastuzumab. In unadjusted analyses, significant treatment benefit on OS was found in patients with T1b tumors. The largest absolute treatment benefits were found in patients with T1b tumors and estrogen receptor (ER) negative tumors, respectively, whereas treatment effects in patients with T1a tumors and ER-positive tumors, respectively, were limited.

Conclusion

Adjuvant chemotherapy and trastuzumab did not improve OS or iDFS significantly in patients with HER2-positive, T1abN0 breast cancers in adjusted analyses. In unadjusted analyses, significant OS benefit was found in patients with T1b tumors. The largest absolute benefit was observed in patients with T1b tumors and ER-negative tumors, respectively, whereas the effect was limited in patients with T1a tumors and ER-positive tumors, respectively.

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Data availability

The datasets generated during and/or analyzed during the current study are not publicly available due to Danish legislation. Access to data from the Danish Breast Cancer Group database can be applied through Danish Clinical Registries (RKKP).

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Funding

This study is part of a PhD-project supported by the Danish Cancer Society, Denmark (R246-A14574-19-S73); Interne Forskningsmidler, Herlev and Gentofte Hospital, Denmark; Tømrermester Jørgen Holm og Hustru Elisa F. Hansens Mindelegat, Denmark (20006-1846); Dansk Kræftforskningsfond, Denmark; Region Sjællands Sundhedsvidenskabelige Forskningsfond, Denmark (R19A283B198); Dansk Brystkirurgisk Selskabs legat, Denmark; Helsefonden, Denmark (20-B-0003). The funding sources had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.

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Authors and Affiliations

  1. Department of Breast Surgery, Herlev and Gentofte Hospital, Copenhagen University Hospital, Gentofte Hospitalsvej 1, 2900, Hellerup, Denmark

    Christina M. S. Hassing, Mathias Kvist Mejdahl, Niels Kroman & Tove Holst Filtenborg Tvedskov

  2. Department of Surgical Pathology, Zealand University Hospital, Sygehusvej 9 (postal: Sygehusvej 10), 4000, Roskilde, Denmark

    Anne-Vibeke Lænkholm

  3. Department of Oncology, Section 4262, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark

    Ann Søegaard Knoop

Authors
  1. Christina M. S. Hassing
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  2. Mathias Kvist Mejdahl
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  3. Anne-Vibeke Lænkholm
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  4. Niels Kroman
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  5. Ann Søegaard Knoop
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  6. Tove Holst Filtenborg Tvedskov
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Contributions

All authors contributed to the study conception and design. All authors were involved in material preparation, data collection, analysis, or interpretation of the analyses. The first draft of the manuscript was written by CH and TT. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Christina M. S. Hassing.

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Conflict of interest

Ann Søegaard Knoop reports personal fees from Novartis, Roche, Merck, Daiichi Sankyo, Gilead Sciences, Pfizer, Eli Lilly. Furthermore, she has been national or site investigator for Daiichi Sankyo and Sanofi. Tove Tvedskov reports speaker honorariums from Roche, MSD and Pfizer. Anne-Vibeke Lænkholm reports institutional research grants from Novartis and Astra Zeneca (AZ). Anne-Vibeke Lænkholm reports personal fees for participation in advisory boards, Novartis and AZ and for a research collaboration with Veracyte. No other potential conflicts of interest were reported.

Ethical approval

This study was approved by the Regional Research Ethics Committee of the Capital Region of Denmark (H-18045702) and by the Regional Data Protection Agency (P-2019-124).

Informed consent

Exception for obtaining informed consent was given by the Regional Research Ethics Committee of the Capital Region of Denmark as the present study implied no health-related risks or discomfort for the involved patients.

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Hassing, C.M.S., Mejdahl, M.K., Lænkholm, AV. et al. Benefit of adjuvant chemotherapy and trastuzumab in patients with HER2-positive, node-negative breast tumors ≤ 10 mm: a nationwide study. Breast Cancer Res Treat 196, 197–206 (2022). https://doi.org/10.1007/s10549-022-06724-y

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