Department of Oncology and Pathology, CCK, Karolinska Institutet, 17176, Stockholm, Sweden.
Department of Clinical Pathology and Cytology, Karolinska University Laboratory, Stockholm, Sweden.
Breast Cancer Res Treat. 2019 Apr;174(3):795-805. doi: 10.1007/s10549-018-05119-2. Epub 2019 Jan 18.
The accuracy of predictive and prognostic biomarker assessment in breast cancer is paramount since these guide therapy decisions. The aim was to investigate the concordance of biomarkers and immunohistochemical (IHC)-based surrogate tumor subtypes between core needle biopsies (CNB) and consecutive paired breast cancer surgical resections.
This retrospective study comprised two cohorts of patients with primary breast cancer diagnosed between 2016 and 2017: one treated with primary surgery (n = 526) and one with neoadjuvant chemotherapy (NAC) (n = 216). The agreement between preoperative CNB and paired tumor specimens regarding the assessment of biomarkers and surrogate tumor subtypes was evaluated in both cohorts.
In the primary surgery cohort, the concordance rates and kappa values for estrogen receptor (ER), progesterone receptor (PR) and Ki67 were 98.6% (κ = 0.917), 89.3% (κ = 0.725) and 78.8% (κ = 0.529), respectively. Importantly, human epidermal growth factor receptor 2 (HER2) IHC assessment showed only moderate agreement (κ = 0.462). HER2 status combining IHC and in situ hybridization was discordant in 3.6% of cases, potentially impacting on indications for HER2-targeted therapy. The concordance rate for IHC-based surrogate tumor subtypes was only 73.2-78.3%. Generally lower concordance rates for ER, PR and HER2 were observed in the NAC cohort. Here, HER2 status was discordant in 7.4%.
The agreement of HER2 and Ki67 between CNB and paired surgical specimen in primary breast cancer is insufficient. Limited agreement of surrogate tumor subtypes indicates a significant clinical value of biomarker re-testing on surgical specimens.
预测和预后生物标志物在乳腺癌中的评估准确性至关重要，因为这些标志物指导着治疗决策。本研究旨在探讨核心针活检（CNB）与连续配对乳腺癌手术切除标本之间生物标志物和免疫组织化学（IHC）替代肿瘤亚型的一致性。
本回顾性研究包括两个原发性乳腺癌患者队列：一组接受原发性手术治疗（n=526），一组接受新辅助化疗（NAC）（n=216）。在两个队列中，评估了术前 CNB 与配对肿瘤标本在评估生物标志物和替代肿瘤亚型方面的一致性。
在原发性手术组中，雌激素受体（ER）、孕激素受体（PR）和 Ki67 的一致性率和 Kappa 值分别为 98.6%（κ=0.917）、89.3%（κ=0.725）和 78.8%（κ=0.529）。重要的是，人表皮生长因子受体 2（HER2）IHC 评估仅显示中度一致性（κ=0.462）。在 3.6%的病例中，HER2 IHC 评估和原位杂交联合评估结果不一致，这可能会影响 HER2 靶向治疗的指征。基于 IHC 的替代肿瘤亚型的一致性率仅为 73.2-78.3%。在 NAC 组中，通常观察到 ER、PR 和 HER2 的一致性较低。在该组中，HER2 状态不一致的比例为 7.4%。
原发性乳腺癌中 CNB 和配对手术标本之间 HER2 和 Ki67 的一致性不足。替代肿瘤亚型的一致性有限表明，对手术标本进行生物标志物重新检测具有重要的临床价值。
