Sensitivity and specificity of MammaTyper® versus immunohistochemistry in the molecular subtyping of breast cancer: The SUBMARIN study

IF 0.3 Q4 OBSTETRICS & GYNECOLOGY

Revista de Senologia y Patologia Mamaria Pub Date : 2025-06-19 DOI:10.1016/j.senol.2025.100706

Laia Bernet-Vegué , Stella Peláez Malagón , Marina Berna Rubio

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Abstract

Introduction

Immunohistochemical study for oestrogen receptor (ER/ESR1), progesterone receptor (PR/PGR), human epidermal growth factor receptor 2 (HER2/ERBB2), and proliferation marker Ki-67/MKI67PR is the standard technique for diagnosing the molecular subtype in clinical practice. However, less subjective techniques, such as the mRNA-quantifying MammaTyper® (MMT), are needed.

Materials and methods

Observational, retrospective, single-centre study carried out at the Vinalopó University Hospital, Alacant, Spain, with 109 consecutive formalin-fixed paraffin-embedded samples coming from infiltrating breast carcinoma diagnosed between 2022 and 2023.

Results

The global concordance of MMT with IHC was 76.15%. MMT results were concordant with IHC in all HER2-positive (4, 100%) or HER2-Luminal B samples (11, 100%), in 45 (95.7%) classified as Luminal B-like (HER2–) and in 11 (84.6%) Triple negative. MMT disagreed on 22 (64.7%) Luminal A-like samples, mainly because MMT detected Ki-67 expression. High values of positive agreement for ER (96.3%, 95% CI: 90.9; 98.6%), PR (89.9%, 95% CI: 82.8; 94.3%), and HER2 (87.0%, 95% CI: 67.9; 95.5%) were obtained. MMT detected more positives than IHC for Ki-67 (52.6%, 95% CI: 43.2; 62.0%) and HER2-low (74.3%, 95% CI: 66.1; 82.5%).

Conclusion

The concordance between both techniques was high for ER, PR, and HER2. Notably, MMT standardises the identification of Luminal A-B-like and HER2-low thanks to its higher sensitivity towards HER2 and Ki-67.

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MammaTyper®与免疫组织化学在乳腺癌分子分型中的敏感性和特异性：SUBMARIN研究

雌激素受体（ER/ESR1）、孕激素受体（PR/PGR）、人表皮生长因子受体2 （HER2/ERBB2）和增殖标志物Ki-67/MKI67PR的免疫组化研究是临床诊断分子亚型的标准技术。然而，需要较少主观的技术，如mrna定量MammaTyper®（MMT）。材料与方法在西班牙Alacant Vinalopó大学医院进行观察性、回顾性、单中心研究，研究对象为2022年至2023年间诊断为浸润性乳腺癌的109例连续使用福尔马林固定石蜡包埋的样本。结果MMT与IHC的全球一致性为76.15%。所有HER2阳性（4.100%）或HER2-Luminal B样本（11.100%），45例（95.7%）归为Luminal B样（HER2 -）， 11例（84.6%）归为三阴性，MMT结果与IHC一致。MMT对22例（64.7%）Luminal A-like样品的检测结果不一致，主要是因为MMT检测到了Ki-67的表达。ER阳性一致性高值(96.3%,95% CI: 90.9；98.6%), pr (89.9%, 95% ci: 82.8；94.3%)和HER2 (87.0%, 95% CI: 67.9；95.5%)。MMT检测Ki-67阳性高于IHC (52.6%, 95% CI: 43.2；62.0%)和her2低(74.3%,95% CI: 66.1；82.5%)。结论两种方法在ER、PR、HER2指标上具有较高的一致性。值得注意的是，由于MMT对HER2和Ki-67的敏感性较高，因此可以标准化Luminal a - b样和HER2-low的鉴定。

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