PMID- 36385963
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221118
IS  - 1687-8450 (Print)
IS  - 1687-8469 (Electronic)
IS  - 1687-8450 (Linking)
VI  - 2022
DP  - 2022
TI  - Effectiveness and Safety of Zercepac and Reference Trastuzumab in the Neoadjuvant 
      Setting for Early-Stage Breast Cancer: A Retrospective Cohort Study.
PG  - 9998114
LID - 10.1155/2022/9998114 [doi]
LID - 9998114
AB  - AIM: Since the high cost of reference trastuzumab limits its clinical 
      application, this study aimed to compare the effectiveness and safety of the 
      Zercepac and reference product trastuzumab in neoadjuvant therapy for 
      HER2-positive breast cancer. METHODS: This study retrospectively collected 
      clinical data of patients with early-stageHER2-positive breast cancer, who 
      received trastuzumab, pertuzumab, docetaxel, and platinum as neoadjuvant therapy 
      from November 2020 to July 2021. Patients were divided into the Zercepac and 
      reference trastuzumab groups. Reduction in tumor size, clinical response based on 
      RECIST1.1 criteria, pathological complete response (pCR), and adverse events 
      (AEs) were evaluated. Multivariate logistic regression analyses were used to 
      adjust confounders. RESULTS: A total of 105 patients were included in the study, 
      among them, 65 were in the Zercepac group and 40 were in the reference 
      trastuzumab group. The percentage of tumor shrinkage from baseline was comparable 
      between the Zercepac and reference trastuzumab group (47.6 +/- 18.6% vs. 
      43.0 +/- 19.9%, p = 0.235). Clinical partial response rate was similar between the 
      two groups (81.5% vs. 70.0%, p = 0.172). There were 28 cases of pCR (70.0%) in 
      the reference trastuzumab group and 46 cases of pCR (70.8%) in the Zercepac group 
      (p = 0.933). The choice of Zercepac or reference trastuzumab was not 
      significantly associated with pCR (OR = 0.96, 95%CI: 0.41-2.28, p = 0.933). 
      Adverse events (AEs) were observed in all patients, and the incidence of >/=3 grade 
      AEs was comparable between the two groups (81.5% vs. 70.0%, p = 0.172). 
      CONCLUSION: Zercepac has similar effectiveness and safety profile compared with 
      reference trastuzumab in neoadjuvant therapy, which provides treatment options 
      for patients with HER2-positive breast cancer.
CI  - Copyright (c) 2022 Zheying Liu et al.
FAU - Liu, Zheying
AU  - Liu Z
AD  - Department of Breast Surgery, Southeast University School of Medicine, Nanjing 
      210009, China.
AD  - Department of Breast Surgery, Jiangbei International Hospital, Nanjing Drum Tower 
      Hospital, Nanjing 211800, China.
FAU - Guan, Yinan
AU  - Guan Y
AD  - Department of Breast Surgery, Southeast University School of Medicine, Nanjing 
      210009, China.
FAU - Yao, Yongzhong
AU  - Yao Y
AUID- ORCID: 0000-0001-7593-8878
AD  - Department of Breast Surgery, Southeast University School of Medicine, Nanjing 
      210009, China.
AD  - Department of Breast Surgery, Jiangbei International Hospital, Nanjing Drum Tower 
      Hospital, Nanjing 211800, China.
FAU - Zhang, Weijie
AU  - Zhang W
AD  - Department of Breast Surgery, Jiangbei International Hospital, Nanjing Drum Tower 
      Hospital, Nanjing 211800, China.
FAU - Zhuang, Xiaoming
AU  - Zhuang X
AD  - Department of Breast Surgery, Jiangbei International Hospital, Nanjing Drum Tower 
      Hospital, Nanjing 211800, China.
FAU - Zhang, Yin
AU  - Zhang Y
AD  - Department of Breast Surgery, Jiangbei International Hospital, Nanjing Drum Tower 
      Hospital, Nanjing 211800, China.
FAU - Zhu, Tingting
AU  - Zhu T
AD  - Department of Breast Surgery, Jiangbei International Hospital, Nanjing Drum Tower 
      Hospital, Nanjing 211800, China.
LA  - eng
PT  - Journal Article
DEP - 20221103
PL  - Egypt
TA  - J Oncol
JT  - Journal of oncology
JID - 101496537
PMC - PMC9649327
COIS- All authors declare that they have no conflicts of interest.
EDAT- 2022/11/18 06:00
MHDA- 2022/11/18 06:01
PMCR- 2022/11/03
CRDT- 2022/11/17 11:36
PHST- 2022/08/24 00:00 [received]
PHST- 2022/09/29 00:00 [accepted]
PHST- 2022/11/17 11:36 [entrez]
PHST- 2022/11/18 06:00 [pubmed]
PHST- 2022/11/18 06:01 [medline]
PHST- 2022/11/03 00:00 [pmc-release]
AID - 10.1155/2022/9998114 [doi]
PST - epublish
SO  - J Oncol. 2022 Nov 3;2022:9998114. doi: 10.1155/2022/9998114. eCollection 2022.