Wang Hao, Cao Hailing, Guo Zhiyun
Department of Pathology, Guangzhou Panyu Central Hospital, Guangzhou, Guangdong 511400, P.R. China.
Department of Thyroid and Breast Surgery, Guangzhou Panyu Central Hospital, Guangzhou, Guangdong 511400, P.R. China.
Oncol Lett. 2023 Jun 6;26(1):314. doi: 10.3892/ol.2023.13900. eCollection 2023 Jul.
Pyrotinib is a novel irreversible tyrosine kinase inhibitor targeting the human epidermal growth factor receptor (HER), whose efficacy in treating metastatic HER2-positive (HER2) breast cancer has been confirmed. The present study aimed to explore the efficacy, safety and prognostic factors of pyrogenic-involved neoadjuvant therapy in patients with HER2 breast cancer. A total of 49 patients with HER2 breast cancer who received pyrotinib-neoadjuvant therapy were recruited. All patients received pyrotinib plus chemotherapy with or without trastuzumab neoadjuvant treatment for six cycles (21 days/cycle). Concerning the clinical response, 4 (8.2%), 36 (73.4%) and 9 (18.4%) patients achieved complete response, partial response and stable disease after 6-cycle pyrotinib-neoadjuvant treatment, respectively; the objective response rate and disease control rate reached 81.6 and 100.0%, respectively. Concerning the pathological response, 23 (46.9%), 12 (24.5%), 12 (24.5%) and 2 (4.1%) patients were evaluated as Miller-Payne grade 5, 4, 3 and 2, respectively. In addition, 23 (46.9%) patients achieved pathological complete response (pCR) in the breast tissue, 40 (81.6%) patients achieved pCR in lymph nodes, while 22 (44.9%) patients obtained total pCR (tpCR). Further multivariate logistic regression analysis demonstrated that pyrotinib plus trastuzumab and chemotherapy (vs. pyrotinib plus chemotherapy) was independently correlated with increased tpCR (P=0.048). The most frequent adverse events included diarrhea (81.6%), anemia (69.4%), nausea and vomiting (63.3%), and fatigue (51.0%). The majority of the adverse events were mild and controllable. In conclusion, pyrotinib-neoadjuvant therapy presented optimal efficacy and mild toxicity in patients with HER2 breast cancer, whose efficacy was affected by the combination treatment with trastuzumab.
吡咯替尼是一种新型不可逆酪氨酸激酶抑制剂，靶向人表皮生长因子受体（HER），其在治疗转移性HER2阳性（HER2）乳腺癌中的疗效已得到证实。本研究旨在探讨吡咯替尼参与的新辅助治疗在HER2乳腺癌患者中的疗效、安全性及预后因素。共招募了49例接受吡咯替尼新辅助治疗的HER2乳腺癌患者。所有患者接受吡咯替尼联合化疗，联合或不联合曲妥珠单抗进行新辅助治疗，共六个周期（21天/周期）。关于临床反应，4例（8.2%）、36例（73.4%）和9例（18.4%）患者在6周期吡咯替尼新辅助治疗后分别达到完全缓解、部分缓解和疾病稳定；客观缓解率和疾病控制率分别达到81.6%和100.0%。关于病理反应，分别有23例（46.9%）、12例（24.5%）、12例（24.5%）和2例（4.1%）患者被评估为米勒-佩恩分级5级、4级、3级和2级。此外，23例（46.9%）患者在乳腺组织中达到病理完全缓解（pCR），40例（81.6%）患者在淋巴结中达到pCR，而22例（44.9%）患者获得了总病理完全缓解（tpCR）。进一步的多因素逻辑回归分析表明，吡咯替尼联合曲妥珠单抗及化疗（与吡咯替尼联合化疗相比）与tpCR增加独立相关（P=0.048）。最常见的不良事件包括腹泻（81.6%）、贫血（69.4%）、恶心和呕吐（63.3%）以及疲劳（51.0%）。大多数不良事件为轻度且可控。总之，吡咯替尼新辅助治疗在HER2乳腺癌患者中呈现出最佳疗效和轻度毒性，其疗效受曲妥珠单抗联合治疗的影响。
