Chao Wan-Ru, Lee Ming-Yung, Lee Yi-Ju, Sheu Gwo-Tarng, Han Chih-Ping
Department of Pathology, Chung-Shan Medical University, Taichung, Taiwan, Republic of China.
Department of Pathology, Chung-Shan Medical University Hospital, Taichung, Taiwan, Republic of China.
Virchows Arch. 2022 May;480(5):1023-1030. doi: 10.1007/s00428-022-03285-9. Epub 2022 Feb 28.
The successful experiences of HER2 inhibitors in patients with HER2 ( +) breast cancer (BC) and advanced gastroesophageal adenocarcinoma (GEA) have encouraged us to continuously explore the HER2 status and its potential as a therapeutic target in primary mucinous ovarian carcinoma (mOC). Using 49 primary mOC samples, we compared the assay characteristics of HER2 status between both 2017 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) for GEA and 2018 ASCO/CAP for BC guideline recommendations. We demonstrated moderate to strong agreement between their HER2 IHC results (Weighted Kappa = 0.78) and perfect agreement between their HER2 FISH results (Kappa = 1.00). The overall concordance of non-equivocal HER2 IHC and HER2 FISH results was 97.56% (kappa = 0.93) by 2017 ASCO/CAP for GEA criteria and 100% (kappa = 1.00) by 2018 ASCO/CAP for BC criteria. The number (n = 8; 16.32%) of HER2 IHC equivocal (score + 2) by 2017 ASCO/CAP for GEA criteria was twofold higher than that (n = 4; 8.16%) by 2018 ASCO/CAP for BC criteria. Additionally, we identified one false-positive (FP) case (n = 1; 2.04%) that was HER2 IHC positive (score + 3), but HER2 FISH non-amplified result by the 2017 ASCO/CAP for GEA criteria. In conclusion, owing to the absence of FP/ FN and fewer equivocal cases of HER2 IHC, we recommend that the 2018 ASCO/CAP for BC are more appropriate than 2017 ASCO/CAP for GEA criteria in appraising the HER2 status in mOC and justifying the inclusion of eligible subjects for basket clinical trials of the newly developmental anti-HER2 treatments.
HER2抑制剂在HER2（+）乳腺癌（BC）和晚期胃食管腺癌（GEA）患者中的成功经验促使我们持续探索HER2状态及其作为原发性黏液性卵巢癌（mOC）治疗靶点的潜力。我们使用49例原发性mOC样本，比较了2017年美国临床肿瘤学会/美国病理学家协会（ASCO/CAP）关于GEA的指南建议和2018年ASCO/CAP关于BC的指南建议中HER2状态的检测特征。我们证明了它们的HER2免疫组化（IHC）结果之间具有中度至高度一致性（加权Kappa = 0.78），HER2荧光原位杂交（FISH）结果之间具有完全一致性（Kappa = 1.00）。根据2017年ASCO/CAP关于GEA的标准，非模棱两可的HER2 IHC和HER2 FISH结果的总体一致性为97.56%（kappa = 0.93），根据2018年ASCO/CAP关于BC的标准为100%（kappa = 1.00）。按照2017年ASCO/CAP关于GEA的标准，HER2 IHC模棱两可（评分+2）的病例数（n = 8；16.32%）是按照2018年ASCO/CAP关于BC的标准（n = 4；8.16%）的两倍。此外，我们发现了1例假阳性（FP）病例（n = 1；2.04%），按照2017年ASCO/CAP关于GEA的标准，该病例HER2 IHC呈阳性（评分+3），但HER2 FISH结果为非扩增。总之，由于不存在假阳性/假阴性且HER2 IHC的模棱两可病例较少，我们建议在评估mOC中的HER2状态以及确定纳入新开发的抗HER2治疗的篮子临床试验的合格受试者时，2018年ASCO/CAP关于BC的标准比2017年ASCO/CAP关于GEA的标准更合适。
