Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831
Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831
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DOI：
10.1093/jnci/94.11.855
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发表时间：
2002-06-05
影响因子：
10.3
通讯作者：
Perez, EA
中科院分区：
文献类型：
--
作者：
Roche, PC;Suman, VJ;Perez, EA
曲妥珠单抗对转移瘤的疗效，加上结节阳性、HER2阳性乳腺癌患者的相对较差的预后，导致对曲妥珠单抗作为辅助治疗的评估。Breast Intergroup(N9831)正在进行一项前瞻性、随机、三臂三阶段试验，对象是当地实验室检测结果显示HER2/neu基因扩增强烈过度表达(3+)HER2蛋白和/或HER2/neu基因扩增的原发、可手术、组织学确诊、结节阳性乳腺癌的妇女。该方案要求使用HercepTest(TM)免疫组织化学和Vosis Path Vysion(TM)荧光原位杂交(FISH)分析对HER2状态进行验证性中央测试。N9831登记的前119名患者的肿瘤标本进行了集中检测；74%的患者HercepTest(TM)3+，66%的患者HER2基因扩增。在当地实验室提交的9个鱼阳性标本中，只有6个(67%)可以通过中央化验确认。中心HercepTest(TM)和中心FISH检测的符合率为92%。地方和中央检测HER2状态之间的一致性很差(74%)，导致修改了N9831的资格标准。
The efficacy of trastuzumab for metastases coupled with the relatively poor prognosis of patients with nodepositive, HER2-positive breast cancer has led to the evaluation of trastuzumab as an adjuvant therapy. A prospective, randomized, three-arm, phase III trial is being conducted by the Breast Intergroup (N9831) for women with primary, operable, histologically confirmed, node-positive breast carcinoma that strongly overexpresses (3+) HER2 protein and/or displays HER2/neu gene amplification, as determined by local laboratory testing. The protocol requires confirmatory central testing of HER2 status using the HercepTest(TM) immunohistochemistry and the Vysis PathVysion(TM) fluorescence in situ hybridization (FISH) assays. Tumor specimens from the first 119 patients enrolled in N9831 were centrally tested; 74% were found to be HercepTest(TM) 3+ and 66% were found to have HER2 gene amplification. Only six of nine (67%) of the specimens submitted by local laboratories as FISH positive could be confirmed by central assays. The concordance for central HercepTest(TM) and central FISH assays was 92%. The poor concordance (74%) between local and central testing for HER2 status has led to modifications in the eligibility criteria for N9831.