PMID- 38114991
OWN - NLM
STAT- MEDLINE
DCOM- 20231221
LR  - 20240103
IS  - 1477-7819 (Electronic)
IS  - 1477-7819 (Linking)
VI  - 21
IP  - 1
DP  - 2023 Dec 19
TI  - Neoadjuvant pyrotinib plus trastuzumab and chemotherapy for HER2-positive breast 
      cancer: a prospective cohort study.
PG  - 389
LID - 10.1186/s12957-023-03266-5 [doi]
LID - 389
AB  - BACKGROUND: This prospective study aims to investigate the efficacy and safety of 
      pyrotinib (P) combined with 4 cycles of epirubicin and cyclophosphamide followed 
      by 4 cycles of taxane and trastuzumab (P + EC-TH) regimen as neoadjuvant therapy 
      for human epidermal growth factor receptor 2 (HER2) positive breast cancer and to 
      investigate the predictive value of p53, p63, and epidermal growth factor 
      receptor (EGFR) status for neoadjuvant efficacy. METHODS: A total of 138 
      HER2-positive breast cancer patients who received neoadjuvant therapy and 
      underwent surgery were included. Case group: 55 patients received P + EC-TH 
      regimen. CONTROL GROUP: 83 patients received EC-TH regimen. The chi-square test, 
      Fisher's exact test, and logistic regression analysis were applied. The primary 
      endpoint was total pathologic complete response (tpCR), and the secondary 
      endpoints were breast pathologic complete response (bpCR), overall response rate 
      (ORR), and adverse events (AEs). RESULTS: In the case group, the tpCR rate was 
      63.64% (35/55), the bpCR rate was 69.09% (38/55), and the ORR was 100.00% 
      (55/55). In the control group, the tpCR rate was 39.76% (33/83), the bpCR rate 
      was 44.58% (37/83), and the ORR was 95.18% (79/83). The case group had 
      significantly higher tpCR and bpCR rates than those of the control group 
      (P < 0.05), but there was no significant difference in ORR (P > 0.05). The tpCR 
      was associated with the status of estrogen receptor (ER), progesterone receptor 
      (PR), and androgen receptor (AR), and the patients with any negative ER, PR, AR, 
      or combined, were more likely to achieve tpCR than those with positive results 
      (P < 0.05). The p53-positive patients were more likely to achieve tpCR and bpCR 
      than p53-negative patients (P < 0.05). The incidence of hypokalemia and diarrhea 
      in the case group was higher than that in the control group (P < 0.05). The AEs 
      developed were all manageable, and no treatment-related death occurred. 
      CONCLUSION: The efficacy and safety of the P + EC-TH regimen were verified by 
      this study. The HER2-positive breast cancer patients treated with the EC-TH 
      neoadjuvant regimen were more likely to achieve tpCR or bpCR if pyrotinib was 
      administered simultaneously.
CI  - (c) 2023. The Author(s).
FAU - Liu, Lu
AU  - Liu L
AD  - Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou 
      University, 1 Jianshe East Road, Zhengzhou, 450052, Henan, China.
FAU - Zhu, Mingzhi
AU  - Zhu M
AD  - Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou 
      University, 1 Jianshe East Road, Zhengzhou, 450052, Henan, China.
FAU - Wang, Yanyan
AU  - Wang Y
AD  - Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou 
      University, 1 Jianshe East Road, Zhengzhou, 450052, Henan, China.
FAU - Li, Muhan
AU  - Li M
AD  - Gastroenterology and Hepatology, The First Affiliated Hospital of Zhengzhou 
      University, 1 Jianshe East Road, Zhengzhou, Henan, 450052, China.
FAU - Gu, Yuanting
AU  - Gu Y
AD  - Department of Breast Surgery, The First Affiliated Hospital of Zhengzhou 
      University, 1 Jianshe East Road, Zhengzhou, 450052, Henan, China. 
      guyuanting2009@163.com.
LA  - eng
PT  - Journal Article
DEP - 20231219
PL  - England
TA  - World J Surg Oncol
JT  - World journal of surgical oncology
JID - 101170544
RN  - P188ANX8CK (Trastuzumab)
RN  - 0 (pyrotinib)
RN  - 0 (Tumor Suppressor Protein p53)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Breast Neoplasms/pathology
MH  - Trastuzumab/therapeutic use
MH  - Prospective Studies
MH  - Neoadjuvant Therapy
MH  - Tumor Suppressor Protein p53
MH  - Receptor, ErbB-2/metabolism
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
PMC - PMC10729398
OTO - NOTNLM
OT  - Breast cancer
OT  - HER2
OT  - Neoadjuvant therapy
OT  - Pyrotinib
OT  - p53
COIS- The authors declare no competing interests.
EDAT- 2023/12/20 06:42
MHDA- 2023/12/21 06:43
PMCR- 2023/12/19
CRDT- 2023/12/20 00:13
PHST- 2023/08/14 00:00 [received]
PHST- 2023/12/05 00:00 [accepted]
PHST- 2023/12/21 06:43 [medline]
PHST- 2023/12/20 06:42 [pubmed]
PHST- 2023/12/20 00:13 [entrez]
PHST- 2023/12/19 00:00 [pmc-release]
AID - 10.1186/s12957-023-03266-5 [pii]
AID - 3266 [pii]
AID - 10.1186/s12957-023-03266-5 [doi]
PST - epublish
SO  - World J Surg Oncol. 2023 Dec 19;21(1):389. doi: 10.1186/s12957-023-03266-5.