• Chunyu Tian, Minghui Wang, Hancheng Liu, Jianping Liu, Mengze Xu, and Lihui Ma.
• Department of Breast Surgery, Affiliated Hospital of Chengde Medical University, No.36 Nanyingzi Street, Shuangqiao District, Chengde, 067000, China.
• Ir J Med Sci. 2023 Jun 1; 192 (3): 104110491041-1049.

ObjectivePyrotinib 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.MethodsA 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.ResultsComplete 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%).ConclusionNeoadjuvant pyrotinib plus TAC treatment is efficient and safe in HER2+ breast cancer patients, while further validation is needed.© 2022. The Author(s), under exclusive licence to Royal Academy of Medicine in Ireland.

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