ArticleAdvances in therapy2026
Addressing the Challenges in the Identification of HER2-Low and Ultralow Breast Cancer in Asia: A Delphi Consensus.
Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionHuman 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.
methodsThe 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%.
resultsAll 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.
conclusionThis 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.
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