Acs Balazs, Fredriksson Irma, Rönnlund Caroline, Hagerling Catharina, Ehinger Anna, Kovács Anikó, Røge Rasmus, Bergh Jonas, Hartman Johan
Department of Oncology and Pathology, Karolinska Institutet, 17176 Stockholm, Sweden.
Department of Clinical Pathology and Cytology, Karolinska University Laboratory, 11883 Stockholm, Sweden.
Cancers (Basel). 2021 Mar 9;13(5):1166. doi: 10.3390/cancers13051166.
We compared estrogen receptor (ER), progesterone receptor (PR), human epidermal growth-factor receptor 2 (HER2), Ki67, and grade scores among the pathology departments in Sweden. We investigated how ER and HER2 positivity rates affect the distribution of endocrine and HER2-targeted treatments among oncology departments. All breast cancer patients diagnosed between 2013 and 2018 in Sweden were identified in the National Quality Register for Breast Cancer. Cases with data on ER, PR, HER2, Ki67, grade, and treatment were selected (43,261 cases from 29 departments following the guidelines for biomarker testing). The ER positivity rates ranged from 84.2% to 97.6% with 6/29 labs out of the overall confidence intervals (CIs), while PR rates varied between 64.8% and 86.6% with 7/29 labs out of the CIs. HER2 positivity rates ranged from 9.4% to 16.3%, with 3/29 labs out of the overall CIs. Median Ki67 varied between 15% and 30%, where 19/29 labs showed significant intra-laboratory variability. The proportion of grade-II cases varied between 42.9% and 57.1%, and 13/29 labs were outside of the CI. Adjusting for patient characteristics, the proportion of endocrine and anti-HER2 treatments followed the rate of ER and HER2 positivity, illustrating the clinical effect of inter- and intra-laboratory variability. There was limited variability among departments in ER, PR, and HER2 testing. However, even a few outlier pathology labs affected endocrine and HER2-targeted treatment rates in a clinically relevant proportion, suggesting the need for improvement. High variability was found in grading and Ki67 assessment, illustrating the need for the adoption of new technologies in practice.
我们比较了瑞典各病理科之间的雌激素受体（ER）、孕激素受体（PR）、人表皮生长因子受体2（HER2）、Ki67和分级分数。我们研究了ER和HER2阳性率如何影响肿瘤内科内分泌治疗和HER2靶向治疗的分布情况。在瑞典国家乳腺癌质量登记处识别出了2013年至2018年间确诊的所有乳腺癌患者。选取了有ER、PR、HER2、Ki67、分级和治疗数据的病例（按照生物标志物检测指南，来自29个科室的43261例病例）。ER阳性率在84.2%至97.6%之间，29个实验室中有6个超出了总体置信区间（CI），而PR率在64.8%至86.6%之间，29个实验室中有7个超出了CI。HER2阳性率在9.4%至16.3%之间，29个实验室中有3个超出了总体CI。Ki67中位数在15%至30%之间，29个实验室中有19个显示出显著的实验室内部变异性。二级病例的比例在42.9%至57.1%之间，29个实验室中有13个超出了CI。调整患者特征后，内分泌治疗和抗HER2治疗的比例与ER和HER2阳性率相符，说明了实验室间和实验室内部变异性的临床影响。各科室在ER、PR和HER2检测方面的变异性有限。然而，即使是少数几个异常的病理实验室也在临床上产生了显著影响，影响了内分泌治疗和HER2靶向治疗的比例，这表明有必要进行改进。在分级和Ki67评估方面发现了高变异性，这说明在实践中需要采用新技术。
