Breast Center, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Chengdu, 610041, Sichuan, China.
Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China.
Breast Cancer Res Treat. 2023 Jan;197(1):189-200. doi: 10.1007/s10549-022-06781-3. Epub 2022 Nov 8.
PURPOSE: The status of human epidermal growth factor receptor 2 (HER2) is important for treatment decision-making of breast cancer and was commonly determined by core needle biopsy (CNB). The concordance of CNB with surgical excision biopsy (SEB) has been verified, but remain unclear according to the newly developed classification of HER2 status. Our study aimed to re-evaluate the diagnostic value of CNB for determining HER2 status in breast cancer, especially in the HER2-low population. METHODS: Eligible breast cancer patients in West China Hospital between January 1, 2007 and December 31, 2021 were enrolled consecutively and data were extracted from the Hospital Information System. The agreement of HER2 status between CNB and SEB was calculated by concordance rate and κ statistics, as well as the sensitivity, specificity, positive, and negative predictive values (PPV & NPV). Logistic models were used to explore potential factors associated with the discordance between both tests. RESULTS: Of 1829 eligible patients, 1097 (60.0%) and 1358 (74.2%) were consistent between CNB and SEB by pathological and clinical classifications, respectively, with κ value being 0.46 (0.43-0.49) and 0.57 (0.53-0.60). The sensitivity (50.9%-52.7%) and PPV (50.5%-55.2%) of CNB were especially low among IHC 1+ and 2+/ISH - subgroups by pathological classifications; however, it showed the highest sensitivity (77.5%) and the lowest specificity (73.9%) in HER2-low population by clinical classifications. Advanced N stages might be a stable indicator for the discordance between both tests. CONCLUSION: The diagnostic value of CNB was limited for determining HER2 status in breast cancer, especially in HER2-low population.
目的:人表皮生长因子受体 2(HER2)的状态对乳腺癌的治疗决策很重要,通常通过核心针活检(CNB)来确定。CNB 与手术切除活检(SEB)的一致性已得到验证,但根据新开发的 HER2 状态分类,其一致性仍不清楚。我们的研究旨在重新评估 CNB 对确定乳腺癌 HER2 状态的诊断价值,特别是在 HER2 低表达人群中。
方法:连续纳入 2007 年 1 月 1 日至 2021 年 12 月 31 日期间在华西医院就诊的乳腺癌患者,并从医院信息系统中提取数据。通过一致性率和 κ 统计量以及敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)来计算 CNB 和 SEB 之间 HER2 状态的一致性。使用逻辑模型来探讨两种检测方法不一致的潜在相关因素。
结果:在 1829 例符合条件的患者中,CNB 和 SEB 的病理分类和临床分类结果分别有 1097 例(60.0%)和 1358 例(74.2%)一致,κ 值分别为 0.46(0.43-0.49)和 0.57(0.53-0.60)。病理分类中 IHC 1+和 2+/ISH-亚组的 CNB 敏感性(50.9%-52.7%)和 PPV(50.5%-55.2%)特别低;而临床分类中 HER2 低表达人群的 CNB 敏感性最高(77.5%),特异性最低(73.9%)。晚期 N 分期可能是两种检测方法不一致的稳定指标。
结论:CNB 对确定乳腺癌 HER2 状态的诊断价值有限,特别是在 HER2 低表达人群中。
Breast Cancer Res Treat. 2023-1
Breast Cancer Res Treat. 2022-5
Clin Transl Oncol. 2025-3-9
N Engl J Med. 2022-7-7
N Engl J Med. 2022-7-7
JAMA Oncol. 2022-4-1
Breast Cancer Res Treat. 2022-2
NPJ Breast Cancer. 2021-1-4