AccScience Publishing / EJMO / Online First / DOI: 10.36922/EJMO025100044
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ORIGINAL RESEARCH ARTICLE

Comparative efficacy and safety of Zercepac® plus pyrotinib versus Zercepac® plus pertuzumab in combination with chemotherapy as neoadjuvant therapy for HER2-positive breast cancer: A retrospective study

Hong Gao1 ,  Jiali Lei2 ,  Zhaohua Gui3 ,  Shengying Wang1*
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1 Department of Thyroid and Breast Surgery, The First Affiliated Hospital of Anhui University of Chinese Medicine (Anhui Provincial Hospital of Chinese Medicine), Hefei, Anhui, China
2 Biomedical Informatics Research Lab, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu, China
3 Division of Life Sciences and Medicine, Department of Pathology, The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China
EJMO, 025100044 https://doi.org/10.36922/EJMO025100044
Received: 4 March 2025 | Revised: 25 April 2025 | Accepted: 28 April 2025 | Published online: 14 May 2025
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution -Noncommercial 4.0 International License (CC-by the license) ( https://creativecommons.org/licenses/by-nc/4.0/ )
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Abstract

HER2-positive breast cancer needs better neoadjuvant options. Pyrotinib (Py) with trastuzumab biosimilar may offer an alternative to dual blockade. This study analyzed the short-term efficacy and safety of Zercepac®, a trastuzumab biosimilar, combined with either Py or pertuzumab and chemotherapy in neoadjuvant therapy for HER2-positive breast cancer. It also compared the efficacy and safety of Zercepac®-pyrotinib-chemotherapy versus Zercepac®-pertuzumab-chemotherapy regimens. Clinical data from 62 HER2-positive breast cancer patients who underwent neoadjuvant therapy with Zercepac® combined with Py or pertuzumab and chemotherapy at Anhui Cancer Hospital (February 2021 to December 2023) were retrospectively analyzed. Efficacy and safety were compared among TCbHP (29 cases), TCbHPy (8 cases), THP (9 cases), and TCbH (16 cases) groups. Statistical methods were used to identify factors influencing total pathological complete response (tpCR). Among the 62 patients, 45 (72.6%) had invasive breast cancer, 11 (17.7%) had invasive carcinomas with intraductal components, five (8.1%) had invasive carcinomas with ductal carcinoma in situ, and one (1.6%) had invasive carcinoma with mucinous features. Age and advanced clinical stage were independent risk factors for tpCR (p<0.001). The TCbHPy group showed comparable efficacy to TCbHP (p=0.25). Alopecia (91.9%) was the most common adverse event. Diarrhea incidence was significantly higher in TCbHPy than in TCbHP (p<0.001); however, no grade 4 diarrhea occurred, and triple antidiarrheal therapy reduced its severity to grade 1. In conclusion, Zercepac® is effective and safe in neoadjuvant therapy for HER2-positive breast cancer. Py (≥400 mg) may improve tpCR rates, with diarrhea as the main adverse effect. TCbHPy regimen demonstrated non-inferior efficacy to TCbHP.

Keywords
Zercepac®
Trastuzumab
Pertuzumab
Pyrotinib
HER2-positive breast cancer
Neoadjuvant therapy
Pathological complete response
Adverse events
Funding
None.
Conflict of interest
The authors declare no conflicts of interest.
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Eurasian Journal of Medicine and Oncology, Electronic ISSN: 2587-196X Print ISSN: 2587-2400, Published by AccScience Publishing
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