Department of Breast Surgery, Affiliated Hospital of Chengde Medical University, No.36 Nanyingzi Street, Shuangqiao District, Chengde, 067000, China.
School of Nursing, Chengde Medical University, Chengde, China.
Ir J Med Sci. 2023 Jun;192(3):1041-1049. doi: 10.1007/s11845-022-03093-9. Epub 2022 Jul 13.
Pyrotinib is a novel EGFR/HER2 dual tyrosine kinase inhibitor developed in China, while its role in neoadjuvant therapy of HER2-positive (HER2) breast cancer lacks evidence. The current study aimed to explore the efficacy and safety of neoadjuvant pyrotinib plus docetaxel/liposomal doxorubicin/cyclophosphamide (TAC) for HER2 breast cancer.
A total of 27 HER2 breast cancer patients received neoadjuvant pyrotinib plus TAC for 6 cycles, then surgery was performed. The clinical and pathological responses, and adverse events were evaluated.
Complete response rate, objective response rate, and disease control rate were 0.0%, 44.4% and 100.0% after 2 treatment cycles; 0.0%, 37.0%, and 100.0% after 4 treatment cycles; 37.0%, 37.0%, and 96.3% after 6 treatment cycles; as well as 37.0%, 44.4%, and 100.0% based on the best clinical response. Regarding pathological response, there were 1 (2.7%), 3 (11.1%), 8 (29.6%), 5 (18.5%), and 10 (37.0%) patients realizing Miller-Payne grade (G) 1, G2, G3, G4, and G5, respectively; besides, 10 (37.0%) patients achieved total pathological complete response (pCR), 10 (37.0%) patients realized pCR in breast, and 23 (85.2%) patients achieved pCR in lymph node. Additionally, adverse events included diarrhea (81.5%), dental ulcer (7.4%), and hand-foot syndrome (3.7%); meanwhile, grade 3-4 adverse event consisted of only diarrhea (11.1%).
Neoadjuvant pyrotinib plus TAC treatment is efficient and safe in HER2 breast cancer patients, while further validation is needed.
吡咯替尼是中国自主研发的一种新型 EGFR/HER2 双靶点酪氨酸激酶抑制剂，但其在 HER2 阳性（HER2）乳腺癌新辅助治疗中的作用尚缺乏证据。本研究旨在探讨吡咯替尼联合多西他赛/脂质体阿霉素/环磷酰胺（TAC）新辅助治疗 HER2 乳腺癌的疗效和安全性。
共 27 例 HER2 乳腺癌患者接受吡咯替尼联合 TAC 治疗 6 个周期，然后行手术治疗。评估临床和病理反应以及不良反应。
治疗 2 个周期后完全缓解率、客观缓解率和疾病控制率分别为 0.0%、44.4%和 100.0%；治疗 4 个周期后分别为 0.0%、37.0%和 100.0%；治疗 6 个周期后分别为 37.0%、37.0%和 96.3%；根据最佳临床反应，分别为 37.0%、44.4%和 100.0%。在病理反应方面，1 例（2.7%）、3 例（11.1%）、8 例（29.6%）、5 例（18.5%）和 10 例（37.0%）患者分别实现 Miller-Payne 分级（G）1、G2、G3、G4 和 G5；此外，10 例（37.0%）患者达到完全病理缓解（pCR），10 例（37.0%）患者在乳腺实现 pCR，23 例（85.2%）患者在淋巴结实现 pCR。此外，不良反应包括腹泻（81.5%）、口腔黏膜炎（7.4%）和手足综合征（3.7%）；同时，仅腹泻（11.1%）为 3-4 级不良反应。
吡咯替尼联合 TAC 治疗 HER2 乳腺癌患者有效且安全，但需要进一步验证。
