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Introduction <p>Human epidermal growth factor receptor type&#xa0;2 (HER2) is overexpressed in 15–20% of primary invasive breast cancers, serving as a key predictive and prognostic factor. HER2-low is defined as immunohistochemistry (IHC) 1+ or 2+ with in situ hybridization (ISH) negative and HER2-ultralow is defined as membrane staining that is incomplete, faint/barely perceptible, and in at most 10% of tumor cells (0+/with membrane staining). Trastuzumab deruxtecan has shown improved outcomes in multiple clinical trials between these groups. A Delphi study was conducted to address challenges in testing, sampling, and reporting, and to identify unmet needs in Asia.</p> Methods <p>The study comprised two online surveys and a participant meeting with 15 pathologists from nine countries in Asia and the Indo-Pacific region. Responses were recorded for 57 close-ended and 33 open-ended statements using a 1–9-point Likert scale ranging from agreement to disagreement with a consensus threshold of 75%.</p> Results <p>All participants completed both surveys and the meeting (100% response). Consensus was reached on 33/57 closed-ended statements (survey&#xa0;1, 27/47; survey&#xa0;2, 6/21), while 24/57 did not reach consensus. Ninety-three percent of participants agreed that biopsies of recurrent lesions should be performed, especially if the primary tumor was HER2-zero. Initially, participants did not reach consensus (73% agreement) on reassessing HER2 results for metastatic lesions scored as HER2-zero but later reached consensus (80% agreement). All testing-related questions reached consensus in survey&#xa0;1.</p> Conclusion <p>This Delphi study found strong consensus on key concepts for sampling, pathological testing, interpretation, and reporting of HER2-low and ultralow breast cancer. While the opinions expressed align with current guidelines, more evidence on the clinicopathological implications is needed.</p>

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Addressing the Challenges in the Identification of HER2-Low and Ultralow Breast Cancer in Asia: A Delphi Consensus

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月12日

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  • Milap Shah,
  • Rowen T. Yolo,
  • Bethy S. Hernowo,
  • Trung Nguyen Cong,
  • Gong Gyungyub,
  • Irianiwati,
  • Lu Bach Kim,
  • Manuelito A. Madrid,
  • Pathmanathan Rajadurai,
  • Pichet Sampatanukul,
  • Shir-Hwa Ueng,
  • Sunil Pasricha,
  • Benjamin Yongcheng Tan,
  • Puay Hoon Tan,
  • Tikamporn Jitpasutham

摘要

Introduction

Human epidermal growth factor receptor type 2 (HER2) is overexpressed in 15–20% of primary invasive breast cancers, serving as a key predictive and prognostic factor. HER2-low is defined as immunohistochemistry (IHC) 1+ or 2+ with in situ hybridization (ISH) negative and HER2-ultralow is defined as membrane staining that is incomplete, faint/barely perceptible, and in at most 10% of tumor cells (0+/with membrane staining). Trastuzumab deruxtecan has shown improved outcomes in multiple clinical trials between these groups. A Delphi study was conducted to address challenges in testing, sampling, and reporting, and to identify unmet needs in Asia.

Methods

The study comprised two online surveys and a participant meeting with 15 pathologists from nine countries in Asia and the Indo-Pacific region. Responses were recorded for 57 close-ended and 33 open-ended statements using a 1–9-point Likert scale ranging from agreement to disagreement with a consensus threshold of 75%.

Results

All participants completed both surveys and the meeting (100% response). Consensus was reached on 33/57 closed-ended statements (survey 1, 27/47; survey 2, 6/21), while 24/57 did not reach consensus. Ninety-three percent of participants agreed that biopsies of recurrent lesions should be performed, especially if the primary tumor was HER2-zero. Initially, participants did not reach consensus (73% agreement) on reassessing HER2 results for metastatic lesions scored as HER2-zero but later reached consensus (80% agreement). All testing-related questions reached consensus in survey 1.

Conclusion

This Delphi study found strong consensus on key concepts for sampling, pathological testing, interpretation, and reporting of HER2-low and ultralow breast cancer. While the opinions expressed align with current guidelines, more evidence on the clinicopathological implications is needed.