2013版 ASCO/CAP HER2检测指南的更新对乳腺癌 HER2基因扩增状态的影响

摘要

Objective To compare the influence of 2007 and 2013 ASCO/ CAP HER2 guideline on HER2 FISH testing on breast cancer. Methods We reviewed the 115 HER2 fluorescence in situ hybridization( FISH)results of before the HER2 guidelines updates and classified them according to both the 2007 and 2013 guidelines as negative,positive,or equivocal. Re-sults Of 115 HER2 FISH results,53(46. 1% )were positive,58(50. 4% )were negative and 4(3. 5% )were equivocal when reassessed by 2007 guidelines. Of 115 HER2 FISH results,55(47. 8% )were positive,53(46. 1% )were negative and 7(6. 1% )were equivocal when reassessed by 2013 guidelines. There was a significant increase in the number of HER2 FISH e-quivocal results after the guideline updates(6. 1% vs 3. 5% ,P ﹤ 0. 001). Conclusion Implementation of the 2013 ASCO/CAP HER2 guideline updates resulted in an increase in HER2 FISH equivocal results,which can be attributed to HER2 copy number,regardless of the HER2 / CEP17 ratio.%目的：比较2007版与2013版 ASCO/ CAP 指南对乳腺癌人类表皮生长因子受体2（HER2）基因扩增状态的影响。方法对 ASCO/ CAP HER2检测指南更新之前的115例乳腺癌荧光原位杂交（FISH）检测样本的 HER2状态进行回顾性分析，分别根据2007版与2013版指南的 HER2判读标准分析其 HER2基因扩增状态。结果采用 FISH 检测的115例样本中，根据2007版指南判定53例（46.1%）为阳性，58例（50.4%）为阴性，4例（3.5%）为不确定；根据2013版新标准重新判定55例（47.8%）为阳性，53例（46.1%）为阴性，7例（6.1%）为不确定。经χ2检验，2013版指南更新后判定为不确定的例数较2007版有显著性增长（6.1%比3.5%，P ﹤0.001）。结论2013版指南发表的 HER2判读标准结合了 HER2/ CEP17比值及平均 HER2基因拷贝数，对一些复杂信号作出了更加明确的指示，指南更新后 HER2基因扩增的不确定例数有显著性增长。