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Efficacy and safety of neoadjuvant pyrotinib plus docetaxel/liposomal doxorubicin/cyclophosphamide for HER2-positive breast cancer

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Abstract

Objective

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.

Methods

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.

Results

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%).

Conclusion

Neoadjuvant pyrotinib plus TAC treatment is efficient and safe in HER2+ breast cancer patients, while further validation is needed.

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Funding

This study was supported by Medical Science Research Project of Hebei Province in 2022 (No. 20220414).

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Authors and Affiliations

  1. Department of Breast Surgery, Affiliated Hospital of Chengde Medical University, No.36 Nanyingzi Street, Shuangqiao District, Chengde, 067000, China

    Chunyu Tian, Minghui Wang, Hancheng Liu, Jianping Liu & Lihui Ma

  2. School of Nursing, Chengde Medical University, Chengde, China

    Mengze Xu

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  1. Chunyu Tian
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Contributions

LM contributed to the conception and design. CT and MW contributed to the data acquisition. HL and JL contributed to the analysis and interpretation of data. MX contributed to drafting/revising of article. All authors provided final approval of the version to be published.

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Correspondence to Lihui Ma.

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The study was permitted by Ethics Committee of Affiliated Hospital of Chengde Medical University with approval of 21–0924.

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Not applicable.

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The authors declare no competing interests.

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Tian, C., Wang, M., Liu, H. et al. Efficacy and safety of neoadjuvant pyrotinib plus docetaxel/liposomal doxorubicin/cyclophosphamide for HER2-positive breast cancer. Ir J Med Sci 192, 1041–1049 (2023). https://doi.org/10.1007/s11845-022-03093-9

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  • DOI: https://doi.org/10.1007/s11845-022-03093-9

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