PMID- 36793595
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230217
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 13
DP  - 2023
TI  - The efficacy and safety of epirubicin and cyclophosphamide combined with 
      pyrotinib in neoadjuvant treatment for HER2-positive breast cancer: A real-world 
      study.
PG  - 1041111
LID - 10.3389/fonc.2023.1041111 [doi]
LID - 1041111
AB  - PURPOSE: Long-term survival benefit of anthracyclines for human epidermal growth 
      factor receptor 2 (HER2)-positive breast cancer is clear. In the neoadjuvant 
      treatment, compared with the monoclonal antibody such as trastuzumab and 
      pertuzumab, the clinical benefit of pyrotinib, a new small-molecule tyrosine 
      kinase inhibitor (TKI), as the main anti-HER2 strategy currently requires more 
      research to determine. Our real-world study is the first prospective 
      observational study in China to evaluate the efficacy and safety of epirubicin 
      (E) and cyclophosphamide (C) with pyrotinib as anti-HER2 therapy in the 
      neoadjuvant setting of patients with stage II-III HER2-positive breast cancer. 
      METHODS: From May 2019 to December 2021, 44 untreated patients with HER2-positive 
      nonspecific invasive breast cancer who received 4 cycles of neoadjuvant EC with 
      pyrotinib. The primary endpoint was pathological complete response (pCR) rate. 
      Secondary endpoints included the overall clinical response, breast pathological 
      complete response rate (bpCR), the rate of axillary lymph nodes pathological 
      negativity and adverse events (AEs). Other objective indicators were the rate of 
      surgical breast-conserving, the negative conversion ratios of tumor markers. 
      RESULTS: Thirty-seven (84.1%) of 44 patients completed this neoadjuvant therapy, 
      and 35 (79.5%) had surgery and were included in the primary endpoint assessment. 
      The objective response rate (ORR) of 37 patients was 97.3%. Two patients reached 
      clinical complete response, 34 obtained clinical partial response, 1 sustained 
      stable disease, and no one had progressive disease. Eleven (31.4%) of 35 patients 
      who had surgery achieved bpCR and the rate of axillary lymph nodes pathological 
      negativity was 61.3%. The tpCR rate was 28.6% (95% CI: 12.8-44.3%). Safety was 
      evaluated in all 44 patients. Thirty-nine (88.6%) had diarrhea, and 2 developed 
      grade 3 diarrhea. Four (9.1%) patients had grade 4 leukopenia. All grade 3-4 AEs 
      could be improved after symptomatic treatment. CONCLUSION: The regimen of 4 
      cycles of EC combined with pyrotinib presented some feasibility in the 
      neoadjuvant setting for HER2-positive breast cancer with manageable safety. New 
      regimens with pyrotinib should be evaluated for higher pCR in future. TRIAL 
      REGISTRATION: chictr.org Identifier: ChiCTR1900026061.
CI  - Copyright (c) 2023 Li, Liang, Luo, Shen, Zhou, Liang, Tang, Yuan and Zeng.
FAU - Li, Fu
AU  - Li F
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Liang, Yimin
AU  - Liang Y
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Luo, Ming
AU  - Luo M
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Shen, Jiayue
AU  - Shen J
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Zhou, Taosheng
AU  - Zhou T
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Liang, Yajing
AU  - Liang Y
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Tang, Xiaoqi
AU  - Tang X
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Yuan, Huiming
AU  - Yuan H
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
FAU - Zeng, Jian
AU  - Zeng J
AD  - Department of Gastrointestinal and Gland Surgery, The First Affiliated Hospital 
      of Guangxi Medical University, Nanning, GuangXi, China.
LA  - eng
PT  - Journal Article
DEP - 20230130
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC9922885
OTO - NOTNLM
OT  - breast cancer
OT  - human epidermal growth factor receptor 2 positive
OT  - neoadjuvant therapy
OT  - pyrotinib
OT  - real-world study
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/02/17 06:00
MHDA- 2023/02/17 06:01
PMCR- 2023/01/01
CRDT- 2023/02/16 02:18
PHST- 2022/09/10 00:00 [received]
PHST- 2023/01/09 00:00 [accepted]
PHST- 2023/02/16 02:18 [entrez]
PHST- 2023/02/17 06:00 [pubmed]
PHST- 2023/02/17 06:01 [medline]
PHST- 2023/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2023.1041111 [doi]
PST - epublish
SO  - Front Oncol. 2023 Jan 30;13:1041111. doi: 10.3389/fonc.2023.1041111. eCollection 
      2023.