To date, multiple potential biomarkers have been investigated among trials involving neoadjuvant therapies. Selecting patients who can achieve pCR based on biomarkers has thus become a vital clinical issue. However, not all HER2-positive patients can achieve pCR when receiving HER2-targeted neoadjuvant therapy. The achievement of pCR has significantly improved the long-term patient outcomes in HER2-positive breast cancer ( 6, 10– 13). Single or dual HER2 blockades in combination with chemotherapy have achieved a pathologically complete response (pCR) of >60% for HER2-positive breast cancer ( 6, 8, 9). The guidelines also suggest that a pertuzumab-containing regimen is useful for patients with T2 or N1 HER2-positive, early-stage breast cancer in a neoadjuvant setting ( 7). The National Comprehensive Cancer Network Guidelines, Version 7 (2021), recommend chemotherapy and trastuzumab-based therapy as preoperative systemic therapies for HER2-positive breast cancer. HER2-targeted therapies such as treatments with trastuzumab, pertuzumab, lapatinib, and trastuzumab emtansine (T-DM1), neratinb, tucatinib, and trastuzumab–deruxtecan, have shown clinically significant efficacy against HER2-positive breast cancer. Neoadjuvant therapy can increase the operability rate for locally advanced diseases and inflammatory subtypes and increase the possibility of breast conservation by reducing tumor bulk or downstaging the tumor ( 4– 6). In approximately 20% of breast cancer cases, the expression of human epidermal growth factor receptor (HER2), which is associated with a poor prognosis, is enhanced ( 1– 3). 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.Ĭonclusions: 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. The AUC of the HER2-enriched subtype had a tendency to be higher than that of the presence of PIK3CA mutations (0.58, p = 0.220). The AUC of the HER2-enriched subtype was significantly higher (0.71) than those for the presence of TILs (0.59, p = 0.003), HRs (0.65, p = 0.003), and Ki-67 (0.62, p = 0.005). Results: 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. Summary receiver operating characteristic (SROC) curves and areas under the curve (AUCs) were used to estimate the diagnostic accuracy. We then calculated the pooled sensitivity, specificity, positive and negative predictive values (PPVs and NPVs, respectively), and positive and negative likelihood ratios (LRs). Methods: 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. 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. Introduction: The predictive strength and accuracy of some biomarkers for the pathological complete response (pCR) to neoadjuvant therapy for HER2-positive breast cancer remain unclear. 2Key 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.1Breast Disease Diagnosis and Treatment Center of Affiliated Hospital of Qinghai University & Affiliated Cancer Hospital of Qinghai University, Xining, China.Fuxing Zhao 1† Xingfa Huo 1† Miaozhou Wang 1† Zhen Liu 1 Yi Zhao 1 Dengfeng Ren 1 Qiqi Xie 1 Zhilin Liu 1 Zitao Li 1 Feng Du 2 Guoshuang Shen 1* Jiuda Zhao 1*
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