Mao Xiaoyun, Lv Pengwei, Gong Yiping, Wu Xiujuan, Tang Peng, Wang Shushu, Zhang Dianlong, You Wei, Wang Ouchen, Zhou Jun, Li Jingruo, Jin Feng
Department of Breast Surgery, The First Affiliated Hospital of China Medical University, Shenyang, China.
Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Front Oncol. 2022 Apr 7;12:855512. doi: 10.3389/fonc.2022.855512. eCollection 2022.
Pyrotinib, a small-molecule tyrosine kinase inhibitor, has been investigated as a component of neoadjuvant therapy in phase 2 trials of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This study aimed to evaluate the effectiveness and safety of pyrotinib-containing neoadjuvant therapy for patients with HER2-positive early or locally advanced breast cancer in the real-world setting.
Data of 97 patients with HER2-positive breast cancer from 21 centers across China treated with pyrotinib-containing neoadjuvant therapy were reviewed. Neoadjuvant therapy consisted of taxane/carboplatin/trastuzumab plus pyrotinib (TCbH+Py, 30 [30.9%]), anthracycline/cyclophosphamide followed by taxane/trastuzumab plus pyrotinib (AC-TH+Py) or taxane followed by anthracycline/cyclophosphamide/trastuzumab plus pyrotinib (T-ACH+Py, 29 [29.9%]), taxane/trastuzumab plus pyrotinib (TH+Py, 23 [23.7%]), and other pyrotinib-containing neoadjuvant treatment (15 [15.5%]). The primary outcome was breast pathological complete response (bpCR, ypT0/is) rate. Secondary outcomes included total pathological complete response (tpCR, ypT0/is ypN0) rate, objective response rate (ORR), and the incidence of preoperative adverse events.
The ORR of pyrotinib-containing neoadjuvant therapy was 87.6% (85/97). The bpCR and tpCR rates were 54.6% (95% confidence interval [CI], 44.2%-64.7%) and 48.5% [95% CI, 38.2%-58.8%], respectively. The most common grade 3 or 4 treatment-related adverse events included diarrhea (15 [15.5%]), decreased hemoglobin (nine [9.3%]), and decreased neutrophil count (eight [8.2%]). No treatment-related deaths occurred.
Pyrotinib-containing neoadjuvant therapy for patients with HER2-positive early or locally advanced breast cancer shows favorable effectiveness with manageable toxicity in the real-world setting. Trastuzumab plus pyrotinib may be a novel option of dual HER2-targeted blockade.
吡咯替尼是一种小分子酪氨酸激酶抑制剂，已在人表皮生长因子受体2（HER2）阳性乳腺癌的2期试验中作为新辅助治疗的一个组成部分进行了研究。本研究旨在评估在现实环境中，含吡咯替尼的新辅助治疗对HER2阳性早期或局部晚期乳腺癌患者的有效性和安全性。
回顾了来自中国21个中心的97例接受含吡咯替尼新辅助治疗的HER2阳性乳腺癌患者的数据。新辅助治疗包括紫杉烷/卡铂/曲妥珠单抗加吡咯替尼（TCbH+Py，30例[30.9%]）、蒽环类/环磷酰胺序贯紫杉烷/曲妥珠单抗加吡咯替尼（AC-TH+Py）或紫杉烷序贯蒽环类/环磷酰胺/曲妥珠单抗加吡咯替尼（T-ACH+Py，29例[29.9%]）、紫杉烷/曲妥珠单抗加吡咯替尼（TH+Py，23例[23.7%]）以及其他含吡咯替尼的新辅助治疗（15例[15.5%]）。主要结局是乳腺病理完全缓解（bpCR，ypT0/is）率。次要结局包括总病理完全缓解（tpCR，ypT0/is ypN0）率、客观缓解率（ORR）以及术前不良事件的发生率。
含吡咯替尼的新辅助治疗的ORR为87.6%（85/97）。bpCR率和tpCR率分别为54.6%（95%置信区间[CI]，44.2%-64.7%）和48.5%[95%CI，38.2%-58.8%]。最常见的3级或4级治疗相关不良事件包括腹泻（15例[15.5%]）、血红蛋白降低（9例[9.3%]）和中性粒细胞计数降低（8例[8.2%]）。未发生治疗相关死亡。
在现实环境中，含吡咯替尼的新辅助治疗对HER2阳性早期或局部晚期乳腺癌患者显示出良好的有效性，且毒性可控。曲妥珠单抗加吡咯替尼可能是一种新型的双HER2靶向阻断选择。
