Real-world performance of HER2 testing - National surgical adjuvant breast and bowel project experience
Real-world performance of HER2 testing - National surgical adjuvant breast and bowel project experience
复制标题
DOI：
10.1093/jnci/94.11.852
复制
发表时间：
2002-06-05
影响因子：
10.3
通讯作者：
Wolmark, N
中科院分区：
文献类型：
--
作者：
Paik, S;Bryant, J;Wolmark, N
曲妥珠单抗（赫赛汀）为诊断为HER 2蛋白过表达或HER 2基因扩增的晚期乳腺癌患者提供临床获益。国家乳腺和肠道手术辅助治疗项目（NSABP）方案B-31旨在检测在多柔比星和环磷酰胺辅助化疗方案中添加赫赛汀，随后使用紫杉醇（Taxol）治疗HER 2过表达或基因扩增的II期乳腺癌的优势。合格性基于累积机构提交的HER 2检测结果。我们根据免疫组织化学（IHC结果）对进入本试验的前104例病例进行了中心审查。我们发现，18%的用于确定患者是否有资格参加B-31研究的基于社区的检测方法无法通过中心检测机构的HercepTest（TM）IHC或荧光原位杂交（FISH）进行确认。本报告提供了在全国实验室进行的HER 2检测的质量快照。
Trastuzumab (Herceptin) provides clinical benefits for patients diagnosed with advanced breast cancers that have overexpressed the HER2 protein or have amplified the HER2 gene. The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-31 is designed to test the advantage of adding Herceptin to the adjuvant chemotherapeutic regimen of doxorubicin and cyclophosphamide followed by paclitaxel (Taxol) in the treatment of stage II breast cancer with HER2 overexpression or gene amplification. Eligibility is based on HER2 assay results submitted by the accruing institutions. We conducted a central review of the first 104 cases entered in this trial on the basis of immunohistochemistry (IHC results. We found that 18% of the community-based assays, which were used to establish the eligibility of patients to participate in the B-31 study, could not be confirmed by HercepTest(TM) IHC or fluorescence in situ hybridization (FISH) by a central testing facility. This report provides a snapshot of the quality of HER2 assays performed in laboratories nationwide.