免疫组化评分 2+浸润性乳腺癌中人表皮生长因子受体 2 荧光原位杂交扩增的预测因子：单机构分析。

Predictors of human epidermal growth factor receptor 2 fluorescence in-situ hybridisation amplification in immunohistochemistry score 2+ infiltrating breast cancer: a single institution analysis.

机构信息

Department of Oncology, Hematology and Respiratory Diseases, University Hospital, Modena, Italy.

出版信息

J Clin Pathol. 2012 Jun;65(6):503-6. doi: 10.1136/jclinpath-2011-200643. Epub 2012 Mar 3.

DOI:10.1136/jclinpath-2011-200643

PMID:22389512

Abstract

AIMS

Eligibility for anti-human epidermal growth factor receptor 2 (HER2) treatments in breast cancer requires a correct HER2 status assessment. Testing guidelines recommend fluorescence in-situ hybridisation (FISH) for samples scored as 2+ by immunohistochemistry. This study investigates the correlation between pathological features and FISH amplification in HER2 2+ breast cancer cases.

METHODS

480 HER2 2+ breast cancer samples were included. The association between tumour grade, hormone receptor status, proliferation index (Ki67) and FISH amplification, using both US Food and Drug Administration (ratio ≥2) and American Society of Clinical Oncologists/College of American Pathologists cut-offs (ratio >2.2) was evaluated.

RESULTS

90.2% of the samples were hormone receptor positive. The median Ki67 value was 23.5%; 311 (64.8%) samples showed a Ki67 value of 15% or greater. Tumour grade was evaluable in 421 cases (87.7%), 268 (55.8%) being grade 3. FISH amplification rates were 27.5% (ratio ≥2.0) and 20.8% (ratio >2.2). Grade 3 tumours were more frequently amplified than grades 1-2 tumours: 34% versus 18% (ratio ≥2.0, p<0.001) and 27% versus 9% (ratio >2.2, p<0.001). Samples with Ki67 of 15% or greater showed higher amplification rates than low Ki67 samples: 31% versus 21% (ratio ≥2.0, p=0.022) and 25% versus 12% (ratio >2.2, p=0.003). The OR for FISH amplification was significant in the case of grade 3 and high Ki67 with both cut-offs.

CONCLUSIONS

In this study, high tumour grade and high Ki67 significantly predicted FISH amplification in 480 HER2 2+ breast cancer samples.

摘要

目的

乳腺癌抗人表皮生长因子受体 2（HER2）治疗的入选标准需要正确的 HER2 状态评估。检测指南建议对免疫组织化学评分为 2+的样本进行荧光原位杂交（FISH）检测。本研究旨在探讨 HER2 2+乳腺癌病例中病理特征与 FISH 扩增之间的相关性。

方法

纳入 480 例 HER2 2+乳腺癌样本。评估肿瘤分级、激素受体状态、增殖指数（Ki67）与 FISH 扩增之间的关系，分别使用美国食品和药物管理局（比值≥2）和美国临床肿瘤学会/美国病理学家协会的标准（比值＞2.2）。

结果

90.2%的样本为激素受体阳性。中位 Ki67 值为 23.5%；311 例（64.8%）样本 Ki67 值为 15%或更高。可评估肿瘤分级的 421 例中，268 例（55.8%）为 3 级。FISH 扩增率为 27.5%（比值≥2.0）和 20.8%（比值＞2.2）。3 级肿瘤比 1-2 级肿瘤更常发生扩增：34%比 18%（比值≥2.0，p＜0.001）和 27%比 9%（比值＞2.2，p＜0.001）。Ki67 值为 15%或更高的样本 FISH 扩增率高于 Ki67 值较低的样本：31%比 21%（比值≥2.0，p=0.022）和 25%比 12%（比值＞2.2，p=0.003）。在两个临界值中，分级 3 级和 Ki67 高均与 FISH 扩增显著相关。