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HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy

Author

Listed:
  • Kazuki Nozawa

    (Nagoya City University Graduate School of Medical Sciences
    Nagoya City University Graduate School of Medical Sciences)

  • Masataka Sawaki

    (Nagoya Medical Center)

  • Yukari Uemura

    (National Center for Global Health and Medicine)

  • Michiko Tsuneizumi

    (Shizuoka General Hospital)

  • Toshimi Takano

    (The Cancer Institute Hospital of JFCR)

  • Naomi Gondo

    (Sagara Hospital)

  • Fumikata Hara

    (Aichi Cancer Center Hospital)

  • Michiko Harao

    (Jichi Medical University)

  • Tatsuya Toyama

    (Nagoya City University Graduate School of Medical Sciences)

  • Naruto Taira

    (Kawasaki Medical School)

  • Ana Vivancos

    (Reveal Genomics)

  • Charles M. Perou

    (University of North Carolina)

  • Esther Sanfeliu

    (Reveal Genomics)

  • Fara Brasó-Maristany

    (Reveal Genomics)

  • Joel S. Parker

    (Reveal Genomics)

  • Wesley Buckingham

    (Reveal Genomics)

  • Laia Paré

    (Reveal Genomics)

  • Guillermo Villacampa

    (Vall d’Hebron Institute of Oncology)

  • Mercedes Marín-Aguilera

    (Reveal Genomics)

  • Patricia Villagrasa

    (Reveal Genomics)

  • Aleix Prat

    (Reveal Genomics
    August Pi i Sunyer Biomedical Research Institute (IDIBAPS)
    Clínic Barcelona Comprehensive Cancer Center
    IOB-QuirónSalud)

  • Hiroji Iwata

    (Nagoya City University Graduate School of Medical Sciences)

Abstract

Older adults with HER2-positive early breast cancer are underrepresented in clinical trials, and the benefit of chemotherapy in this population remains uncertain. We evaluated the HER2DX genomic assay within the randomized RESPECT trial (NCT01104935), which compared adjuvant trastuzumab with or without chemotherapy in patients aged 70–80 years. In this prespecified translational analysis (Trans-RESPECT), HER2DX scores were available for 154 patients. The HER2DX risk score classified 74.0% as low risk and 26.0% as high risk. Ten-year relapse-free and overall survival were higher in the low-risk group. HER2DX remained independently associated with overall survival in multivariable analysis. The HER2DX immune, luminal, and proliferation signatures that compose the risk score were also prognostic. While the HER2DX pCR score was not prognostic overall, exploratory subgroup analyses suggested a potential survival benefit from chemotherapy in the pCR-high group. HER2DX offers prognostic value and may guide chemotherapy use in older patients with HER2-positive early breast cancer. Clinical Trial Information NCT01104935

Suggested Citation

  • Kazuki Nozawa & Masataka Sawaki & Yukari Uemura & Michiko Tsuneizumi & Toshimi Takano & Naomi Gondo & Fumikata Hara & Michiko Harao & Tatsuya Toyama & Naruto Taira & Ana Vivancos & Charles M. Perou & , 2025. "HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy," Nature Communications, Nature, vol. 16(1), pages 1-11, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-65599-x
    DOI: 10.1038/s41467-025-65599-x
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