PMID- 35070899
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240405
IS  - 2227-684X (Print)
IS  - 2227-8575 (Electronic)
IS  - 2227-684X (Linking)
VI  - 10
IP  - 12
DP  - 2021 Dec
TI  - Clinical observation of neoadjuvant chemotherapy with pyrotinib plus trastuzumab 
      in HER2-positive breast cancer: a cohort study.
PG  - 3389-3402
LID - 10.21037/gs-21-794 [doi]
AB  - BACKGROUND: Pyrotinib is a new small-molecule tyrosine kinase inhibitor (TKI). 
      However, the efficacy of pyrotinib in neoadjuvant therapy for HER2-positive 
      breast cancer is unknown. This paper is a population-based cohort study, and the 
      purpose is to evaluate the efficacy and safety of pyrotinib plus trastuzumab in a 
      neoadjuvant setting for HER2-positive early or locally advanced breast cancers, 
      and to compare it with that of pertuzumab plus trastuzumab. METHODS: This cohort 
      study included 166 patients with HER2-positive breast cancer who received 
      neoadjuvant therapy and underwent surgery. Case groups: Group I: 63 patients 
      received pyrotinib + trastuzumab; Group II: 50 patients received pertuzumab + 
      trastuzumab. The control group consisted of 53 patients treated with trastuzumab 
      alone in combination with neoadjuvant chemotherapy. Univariate logistic 
      regression analysis was applied. Enumeration data were processed by Fisher's 
      exact test. RESULTS: The total pathological complete response (tpCR) rate of 
      Group I was 63.49% (40/63); the breast pathological complete response (bpCR) rate 
      was 76.19% (48/63); and the objective response rate (ORR) was 100% (63/63). 
      Compared with the tpCR rate of 54.00% (27/50), bpCR rate of 58.00% (29/50), and 
      ORR 100% (50/50) of Group II, there was no statistical difference. Regarding 
      adverse events (AEs), diarrhea (n=56, 88.89%) was the most frequent in the group 
      I, including 7 participants who developed grade 3 diarrhea (11.11%), followed by 
      leukopenia (n=48, 76.19%). In the meantime, there was only 1 patient experienced 
      grade IV thrombocytopenia. Hormone receptor (HR)-negative patients were more 
      likely to reach tpCR as compared to HR-positive patients (61.54% vs. 37.50%, 
      P=0.002, 95% CI: 1.423 to 4.997), and the tpCR rate of tumor, node, metastasis 
      (TNM) stage III 37.04% (20/54) was significantly lower than that of stage II 
      54.46% (61/112), which was statistically significant (P=0.048, 95% CI: 1.064 to 
      4.041). No recurrence or metastasis was found during short-term follow-up. 
      CONCLUSIONS: Pyrotinib plus trastuzumab combined with neoadjuvant chemotherapy 
      showed good short-term efficacy in HER2-positive breast cancer, and the AEs 
      developed were all manageable. More sample data is required to further support 
      the comparison with pertuzumab plus trastuzumab.
CI  - 2021 Gland Surgery. All rights reserved.
FAU - Li, Qi
AU  - Li Q
AD  - The Second Department of Breast Surgery, The First Affiliated Hospital of 
      Zhengzhou University, Zhengzhou, China.
FAU - Wang, Yanyan
AU  - Wang Y
AD  - The Second Department of Breast Surgery, The First Affiliated Hospital of 
      Zhengzhou University, Zhengzhou, China.
FAU - Zhu, Mingzhi
AU  - Zhu M
AD  - The Second Department of Breast Surgery, The First Affiliated Hospital of 
      Zhengzhou University, Zhengzhou, China.
FAU - Gu, Yuanting
AU  - Gu Y
AD  - The Second Department of Breast Surgery, The First Affiliated Hospital of 
      Zhengzhou University, Zhengzhou, China.
FAU - Tang, Yajing
AU  - Tang Y
AD  - The Second Department of Breast Surgery, The First Affiliated Hospital of 
      Zhengzhou University, Zhengzhou, China.
LA  - eng
PT  - Journal Article
PL  - China (Republic : 1949- )
TA  - Gland Surg
JT  - Gland surgery
JID - 101606638
PMC - PMC8749088
OTO - NOTNLM
OT  - Pyrotinib
OT  - breast cancer
OT  - human epidermal growth factor-2 (HER2)
OT  - neoadjuvant therapy
OT  - pertuzumab
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at https://dx.doi.org/10.21037/gs-21-794). All authors report 
      funding from 2021 Young Talent Promotion Project of Henan Province, China (No. 
      2021HYTP050). The authors have no other conflicts of interest to declare.
EDAT- 2022/01/25 06:00
MHDA- 2022/01/25 06:01
PMCR- 2021/12/01
CRDT- 2022/01/24 08:54
PHST- 2021/11/05 00:00 [received]
PHST- 2021/12/17 00:00 [accepted]
PHST- 2022/01/24 08:54 [entrez]
PHST- 2022/01/25 06:00 [pubmed]
PHST- 2022/01/25 06:01 [medline]
PHST- 2021/12/01 00:00 [pmc-release]
AID - gs-10-12-3389 [pii]
AID - 10.21037/gs-21-794 [doi]
PST - ppublish
SO  - Gland Surg. 2021 Dec;10(12):3389-3402. doi: 10.21037/gs-21-794.