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Eurasian Journal of Medicine

                                                                                    and Oncology





                                        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



                                                                                            1
                                                                       3
                                        Hong Gao , Jiali Lei 2  , Zhaohua Gui , and Shengying Wang *
                                                 1
                                        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



                                        Abstract

                                        Introduction:  HER2-positive breast  cancer needs better  neoadjuvant options.
            *Corresponding author:
            Shengying Wang              Pyrotinib (Py) with trastuzumab biosimilar may offer an alternative to dual
            (wangshengying61@163.com)   blockade. Objective: This study analyzed the short-term efficacy and safety of
            Citation: Gao H, Lei J, Gui Z,   Zercepac®, a trastuzumab biosimilar, combined with either Py or pertuzumab and
            Wang S. Comparative efficacy and   chemotherapy in neoadjuvant therapy for HER2-positive breast cancer. It also
            safety of Zercepac  plus pyrotinib   compared  the  efficacy  and  safety  of  Zercepac®-pyrotinib-chemotherapy  versus
                         ®
            versus Zercepac  plus pertuzumab
                        ®
            in combination with chemotherapy   Zercepac®-pertuzumab-chemotherapy regimens.
            as neoadjuvant therapy for   Methods: Clinical data from 62 HER2-positive breast cancer patients who underwent
            HER2-positive breast cancer: A   neoadjuvant therapy with Zercepac® combined with Py or pertuzumab and
            retrospective study. Eurasian J Med
            Oncol. 2025;9(3):110-121.   chemotherapy at Anhui Cancer Hospital (February 2021 to December 2023) were
            doi: 10.36922/EJMO025100044  retrospectively analyzed. Efficacy and safety were compared among TCbHP (29 cases),
            Received: March 4, 2025     TCbHPy (8 cases), THP (9 cases), and TCbH (16 cases) groups. Statistical methods were
                                        used to identify factors influencing total pathological complete response (tpCR).
            1st revised: April 20, 2025  Results: Among the 62 patients, 45 (72.6%) had invasive breast cancer, 11 (17.7%)
            2nd revised: April 25, 2025  had invasive carcinomas with intraductal components, five (8.1%) had invasive
            Accepted: April 28, 2025    carcinomas with ductal carcinoma in situ, and one (1.6%) had invasive carcinoma
                                        with mucinous features. Age and advanced clinical stage were independent risk
            Published online: May 14, 2025  factors for tpCR (p<0.001). The TCbHPy group showed comparable efficacy to TCbHP
            Copyright: © 2025 Author(s).   (p=0.25). Alopecia (91.9%) was the most common adverse event. Diarrhea incidence
            This is an Open-Access article   was significantly higher in TCbHPy than in TCbHP (p<0.001); however, no grade 4
            distributed under the terms of the
            Creative Commons Attribution   diarrhea occurred, and triple antidiarrheal therapy reduced its severity to grade 1.
            License, permitting distribution,   Conclusion: Zercepac® is effective and safe in neoadjuvant therapy for HER2-positive
            and reproduction in any medium,   breast cancer. Py (≥400 mg) may improve tpCR rates, with diarrhea as the main
            provided the original work is
            properly cited.             adverse effect. TCbHPy regimen demonstrated non-inferior efficacy to TCbHP.
            Publisher’s Note: AccScience
            Publishing remains neutral with   Keywords: Zercepac ; Trastuzumab; Pertuzumab; Pyrotinib; HER2-positive breast cancer;
                                                        ®
            regard to jurisdictional claims in
            published maps and institutional   Neoadjuvant therapy; Pathological complete response; Adverse events
            affiliations.

            Volume 9 Issue 3 (2025)                        110                         doi: 10.36922/EJMO025100044
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