Quality assessment of HER2 testing by monitoring of positivity rates
Quality assessment of HER2 testing by monitoring of positivity rates
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DOI：
10.1007/s00428-011-1132-8
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发表时间：
2011-09-01
期刊：
影响因子：
3.5
通讯作者：
Kreipe, Hans
中科院分区：
文献类型：
--
作者：
Choritz, Harald;Buesche, Guntram;Kreipe, Hans
人表皮生长因子受体 2 (HER2) 检测的实验室间差异给乳腺癌和胃癌的靶向治疗带来了挑战。对实验室之间的阳性率进行评估可以帮助监测其表现并确定某个地理区域预期阳性率的参考值。病理学家定期确定实验室中 HER2 阳性病例（HER2 3+、HER2 2+/扩增或扩增）的数量，并将数据不断输入中央网站。计算每个参与者的总体阳性率，并与所有其他机构的平均阳性率进行比较（n = 42）。共有18,081个乳腺癌检测结果和982个胃癌检测结果被输入该系统。乳腺癌中 HER2 的阳性率范围为 7.6% 至 31.6%。从统计上看，六家机构的结果属于异常值（p < 0.000005）。在包含 10,916 项评估的其余机构中，阳性病例的平均比例为 16.7 +/- 3.2%（99% 置信区间为 16.6-16.8）。六家机构的结果介于 95% 和 99.5% 置信区间之间。对于胃癌，有一个异常值，平均阳性率为 23.2 +/- 5.7%。 HER2 阳性乳腺癌病例的比例远低于已发表研究的预期。通过评估阳性率并将其与特定人群中所有乳腺癌或胃癌的阳性率进行比较，病理学家将警惕其实验室检测中潜在的系统错误，从而导致高估或低估适合抗 HER2 治疗的癌症病例。
Interlaboratory variation in human epidermal growth factor receptor 2 (HER2) testing provides a challenge for targeted therapy in breast and gastric cancer. Assessment of positivity rates among laboratories could help monitor their performance and define reference values for positivity rates to be expected in a geographic region. Pathologists regularly determined the number of HER2-positive cases (HER2 3+, HER2 2+/amplified or amplified) in their laboratory, and figures were continuously entered into a central website. The overall positivity rate of each participant was calculated and compared with the average rates of all other institutes (n = 42). A total of 18,081 test results on breast cancer and 982 on gastric cancer were entered into the system. Positivity rates for HER2 in breast cancer ranged from 7.6% to 31.6%. Statistically, the results from six institutions qualified as outliers (p < 0.000005). From the remaining institutions encompassing 10,916 assessments, the mean proportion of positive cases was 16.7 +/- 3.2% (99% confidence interval 16.6-16.8). The results from six institutions were in between the 95% and 99.5% confidence intervals. For gastric cancer, there was one outlier and the mean positivity rate was 23.2 +/- 5.7%. The proportion of HER2-positive breast cancer cases is considerably lower than could have been expected from published studies. By assessing the positivity rates and comparing them with that of all breast or gastric cancers in a given population, pathologists will be alerted to a potential systematic error in their laboratory assay, causative for over- or underestimation of cancer cases suited for anti-HER2 therapy.