Zhao Fuxing, Huo Xingfa, Wang Miaozhou, Liu Zhen, Zhao Yi, Ren Dengfeng, Xie Qiqi, Liu Zhilin, Li Zitao, Du Feng, Shen Guoshuang, Zhao Jiuda
Breast Disease Diagnosis and Treatment Center of Affiliated Hospital of Qinghai University & Affiliated Cancer Hospital of Qinghai University, Xining, China.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), The VIPII Gastrointestinal Cancer Division of Medical Department, Peking University Cancer Hospital and Institute, Beijing, China.
Front Oncol. 2021 Oct 28;11:731148. doi: 10.3389/fonc.2021.731148. eCollection 2021.
The predictive strength and accuracy of some biomarkers for the pathological complete response (pCR) to neoadjuvant therapy for HER2-positive breast cancer remain unclear. This study aimed to compare the accuracy of the HER2-enriched subtype and the presence of PIK3CA mutations, namely, TILs, HRs, and Ki-67, in predicting the pCR to HER2-positive breast cancer therapy.
We screened studies that included pCR predicted by one of the following biomarkers: the HER2-enriched subtype and the presence of PIK3CA mutations, TILs, HRs, or Ki-67. We then calculated the pooled sensitivity, specificity, positive and negative predictive values (PPVs and NPVs, respectively), and positive and negative likelihood ratios (LRs). Summary receiver operating characteristic (SROC) curves and areas under the curve (AUCs) were used to estimate the diagnostic accuracy.
The pooled estimates of sensitivity and specificity for the HER2-enriched subtype and the presence of PIK3CA mutations, namely, TILs, HRs, and Ki-67, were 0.66 and 0.62, 0.85 and 0.27, 0.49 and 0.61, 0.54 and 0.64, and 0.68 and 0.51, respectively. The AUC of the HER2-enriched subtype was significantly higher (0.71) than those for the presence of TILs (0.59, = 0.003), HRs (0.65, = 0.003), and Ki-67 (0.62, = 0.005). The AUC of the HER2-enriched subtype had a tendency to be higher than that of the presence of PIK3CA mutations (0.58, = 0.220). Moreover, it had relatively high PPV (0.58) and LR+ (1.77), similar NPV (0.73), and low LR- (0.54) compared with the other four biomarkers.
The HER2-enriched subtype has a moderate breast cancer diagnostic accuracy, which is better than those of the presence of PIK3CA mutations, TILs, HRs, and Ki-67.
某些生物标志物对HER2阳性乳腺癌新辅助治疗的病理完全缓解（pCR）的预测强度和准确性仍不明确。本研究旨在比较HER2富集亚型以及PIK3CA突变（即肿瘤浸润淋巴细胞（TILs）、激素受体（HRs）和Ki-67）在预测HER2阳性乳腺癌治疗的pCR方面的准确性。
我们筛选了包含以下生物标志物之一预测pCR的研究：HER2富集亚型以及PIK3CA突变、TILs、HRs或Ki-67的存在情况。然后我们计算了合并敏感性、特异性、阳性和阴性预测值（分别为PPV和NPV）以及阳性和阴性似然比（LRs）。采用汇总受试者工作特征（SROC）曲线和曲线下面积（AUC）来估计诊断准确性。
HER2富集亚型以及PIK3CA突变、TILs、HRs和Ki-67的存在情况的敏感性和特异性的合并估计值分别为0.66和0.62、0.85和0.27、0.49和0.61、0.54和0.64以及0.68和0.51。HER2富集亚型的AUC（0.71）显著高于TILs存在情况的AUC（0.59，P = 0.003）、HRs存在情况的AUC（0.65，P = 0.003）和Ki-67存在情况的AUC（0.62，P = 0.005）。HER2富集亚型的AUC有高于PIK3CA突变存在情况的AUC（0.58，P = 0.220）的趋势。此外，与其他四种生物标志物相比，它具有相对较高的PPV（0.58）和LR+（1.77）、相似的NPV（0.73）以及较低的LR-（0.54）。
HER2富集亚型具有中等的乳腺癌诊断准确性，优于PIK3CA突变、TILs、HRs和Ki-67的存在情况的诊断准确性。
