International journal of surgery (London, England) · 2025
Efficacy, safety, and biomarkers of neoadjuvant trastuzumab and pertuzumab combined with chemotherapy in Chinese patients with HER2-positive breast cancer: a multicenter retrospective cohort study.
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Qi Xiaowei, Hu Hong, Qiu Pengfei, Chen Wenlin, Wang Xiaochun, Shi Qiyun, Xu Yan, Liu Shu, Fang Yanman, Li Taolang, Ming Jia, Zhou Sihai, Chai Fan, Liang Yueyang, Fan Yuanming, Tang Peng, Chen Li, Wang Shushu, Jiang Jun, Wang Mengyuan, Zhang Yi, Nie Jianyun, Wang Yongsheng
Аннотация
OBJECTIVE: This multicenter real-world study aimed to evaluate the efficacy, safety, and neoadjuvant trastuzumab and pertuzumab combined with different chemotherapy regimens in Chinese patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
METHODS: A retrospective analysis was conducted on 557 patients treated at 15 institutions in China between January 2019 and December 2021. Patients were divided into three groups based on chemotherapy regimens: EC-THP (epirubicin, cyclophosphamide, docetaxel/paclitaxel protein-bound, trastuzumab, pertuzumab), TCbHP (docetaxel/paclitaxel protein-bound, carboplatin, trastuzumab, pertuzumab), and THP (docetaxel/paclitaxel protein-bound, trastuzumab, pertuzumab).The primary endpoint was total pathological complete response (tpCR), defined as the absence of invasive disease in both the breast and axillary lymph nodes (ypT0/is, ypN0). Secondary endpoints included axillary pCR (ypN0), breast pCR (ypT0/is), and safety. Propensity score overlap weighting was applied to minimize confounding factors.
RESULTS: Of the 557 patients included in the study, 341 (61.2%) achieved tpCR. The tpCR rate was significantly higher in the HER2-positive hormone receptor (HR)-negative group (183/242 patients, 75.6%) than in the HER2-positive HR-positive group (158/315 patients, 50.2%, P < 0.001), as well as bpCR was achieved in 188/241 patients (77.7%) in the HER2-positive HR-negative group compared to 164/315 patients (52.1%) in the HER2-positive HR-positive group ( P < 0.001), and apCR was achieved in 214/242 patients (88.4%) vs. 240/315 patients (76.2%), respectively ( P < 0.001). After applying propensity score overlap weighting, no significant differences were observed among the three treatment regimen groups in tpCR (68.4% vs. 63.0% vs. 54.5%, P = 0.116), bpCR (71.3% vs. 64.0% vs. 59.6%, P = 0.198), or apCR (80.2% vs. 84.4% vs. 73.9%, P = 0.173). Gene analysis suggested favorable tpCR trends in patients with TP53, ERBB2, MYC, or CCND1 alterations, though not statistically significant. Most adverse events were grades 1-2, with anemia (254/557, 45.6%), leukopenia (147/557, 26.4%), and reduced ejection fraction (99/421, 23.4%) being the most common. No fatal toxicities were reported.
CONCLUSIONS: Trastuzumab and pertuzumab combined with different chemotherapy regimens demonstrated high tpCR rates and manageable safety in HER2-positive breast cancer, particularly in HER2-positive HR-negative patients. The study supports the real-world efficacy of dual HER2-targeted neoadjuvant therapy, though further validation of biomarkers and long-term outcomes is needed.
METHODS: A retrospective analysis was conducted on 557 patients treated at 15 institutions in China between January 2019 and December 2021. Patients were divided into three groups based on chemotherapy regimens: EC-THP (epirubicin, cyclophosphamide, docetaxel/paclitaxel protein-bound, trastuzumab, pertuzumab), TCbHP (docetaxel/paclitaxel protein-bound, carboplatin, trastuzumab, pertuzumab), and THP (docetaxel/paclitaxel protein-bound, trastuzumab, pertuzumab).The primary endpoint was total pathological complete response (tpCR), defined as the absence of invasive disease in both the breast and axillary lymph nodes (ypT0/is, ypN0). Secondary endpoints included axillary pCR (ypN0), breast pCR (ypT0/is), and safety. Propensity score overlap weighting was applied to minimize confounding factors.
RESULTS: Of the 557 patients included in the study, 341 (61.2%) achieved tpCR. The tpCR rate was significantly higher in the HER2-positive hormone receptor (HR)-negative group (183/242 patients, 75.6%) than in the HER2-positive HR-positive group (158/315 patients, 50.2%, P < 0.001), as well as bpCR was achieved in 188/241 patients (77.7%) in the HER2-positive HR-negative group compared to 164/315 patients (52.1%) in the HER2-positive HR-positive group ( P < 0.001), and apCR was achieved in 214/242 patients (88.4%) vs. 240/315 patients (76.2%), respectively ( P < 0.001). After applying propensity score overlap weighting, no significant differences were observed among the three treatment regimen groups in tpCR (68.4% vs. 63.0% vs. 54.5%, P = 0.116), bpCR (71.3% vs. 64.0% vs. 59.6%, P = 0.198), or apCR (80.2% vs. 84.4% vs. 73.9%, P = 0.173). Gene analysis suggested favorable tpCR trends in patients with TP53, ERBB2, MYC, or CCND1 alterations, though not statistically significant. Most adverse events were grades 1-2, with anemia (254/557, 45.6%), leukopenia (147/557, 26.4%), and reduced ejection fraction (99/421, 23.4%) being the most common. No fatal toxicities were reported.
CONCLUSIONS: Trastuzumab and pertuzumab combined with different chemotherapy regimens demonstrated high tpCR rates and manageable safety in HER2-positive breast cancer, particularly in HER2-positive HR-negative patients. The study supports the real-world efficacy of dual HER2-targeted neoadjuvant therapy, though further validation of biomarkers and long-term outcomes is needed.