PMID- 36199295
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221007
IS  - 1178-6930 (Print)
IS  - 1178-6930 (Electronic)
IS  - 1178-6930 (Linking)
VI  - 15
DP  - 2022
TI  - Efficacy and Safety of Pyrotinib in Human Epidermal Growth Factor Receptor 
      2-Positive Advanced Breast Cancer: A Multicenter, Retrospective, Real-World 
      Study.
PG  - 1067-1078
LID - 10.2147/OTT.S379591 [doi]
AB  - PURPOSE: Pyrotinib, a novel human epidermal growth factor receptor 2 
      (HER2)-targeted tyrosine kinase inhibitor (TKI), has led to remarkable survival 
      outcomes in HER2-positive advanced breast cancer (ABC) in clinical trials and was 
      approved for second-line standards of treatment for HER2+ ABC in China. However, 
      the clinical trials could not fully reflect reality of clinical practice, and 
      predictive factors were still lacking. This study aimed to assess the actual 
      efficacy and safety of pyrotinib in HER2+ ABC in real-world setting. PATIENTS AND 
      METHODS: In this multicenter, retrospective, observational real-world study, we 
      analyzed 171 patients with HER2+ ABC, who received pyrotinib-based treatment from 
      November 2017 to November 2020. The primary end point was progression-free 
      survival (PFS). Secondary end points included overall survival (OS), objective 
      response rate (ORR), clinical benefit rate (CBR) and safety. RESULTS: Up to 
      November 30, 2021, the median PFS (mPFS) was 12.0 months for all patients. One 
      hundred and sixty-two patients (94.7%) with measurable lesions had been included 
      in efficacy assessment. The ORR and CBR were 45.1% and 81.5%, respectively. A 
      significantly longer PFS was reported in patients who received pyrotinib as 
      first-line treatment, had the ECOG-PS of 0-1, as well as those who were 
      lapatinib-naive. In addition, multivariable analysis indicated that ECOG-PS of 
      2-4, positive hormone receptor (HR) status, and presence of visceral metastasis 
      were independent negative predictors of PFS. As far as we know, this study first 
      reported the survival outcome of pyrotinib cross-line treatment, with a mPFS of 
      5.0 months. All grades of adverse events (AEs) occurred in 171 patients (100%), 
      and the most common AE was diarrhea (86.5%). CONCLUSION: This study further 
      demonstrated the outstanding efficacy and safety of pyrotinib and reported the 
      potential predictors of survival in HER2+ ABC.
CI  - (c) 2022 Zhang et al.
FAU - Zhang, Xiaoling
AU  - Zhang X
AD  - Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, 
      People's Republic of China.
FAU - Li, Zhaohui
AU  - Li Z
AD  - Department of Oncology, Anshan Cancer Hospital, Anshan, People's Republic of 
      China.
FAU - Han, Linlin
AU  - Han L
AD  - Health Management Center, The Second Hospital of Dalian Medical University, 
      Dalian, People's Republic of China.
FAU - Lv, Zheng
AU  - Lv Z
AD  - Department of Oncology, The First Hospital of Jilin University, Changchun, 
      People's Republic of China.
FAU - Teng, Yuee
AU  - Teng Y
AD  - Department of Oncology, The First Hospital of China Medical University, Shenyang, 
      People's Republic of China.
FAU - Cui, Xiujie
AU  - Cui X
AD  - Department of Oncology, Chaoyang Center Hospital, Chaoyang, People's Republic of 
      China.
FAU - Zhou, Caiyun
AU  - Zhou C
AD  - Department of Oncology, Huludao Center Hospital, Huludao, People's Republic of 
      China.
FAU - Wu, Hongwei
AU  - Wu H
AD  - Department of Oncology, Yingkou Center Hospital, Yingkou, People's Republic of 
      China.
FAU - Fang, Wei
AU  - Fang W
AD  - Department of Oncology, Yingkou Center Hospital, Yingkou, People's Republic of 
      China.
FAU - Xu, Lingzhi
AU  - Xu L
AD  - Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, 
      People's Republic of China.
FAU - Zhao, Shanshan
AU  - Zhao S
AD  - Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, 
      People's Republic of China.
FAU - Song, Chen
AU  - Song C
AD  - Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, 
      People's Republic of China.
FAU - Zheng, Yuanyuan
AU  - Zheng Y
AD  - Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, 
      People's Republic of China.
FAU - Gao, Tianqi
AU  - Gao T
AD  - Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, 
      People's Republic of China.
FAU - Li, Man
AU  - Li M
AD  - Department of Oncology, The Second Hospital of Dalian Medical University, Dalian, 
      People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20220928
PL  - New Zealand
TA  - Onco Targets Ther
JT  - OncoTargets and therapy
JID - 101514322
PMC - PMC9527812
OTO - NOTNLM
OT  - breast cancer
OT  - prognostic factor
OT  - targeted therapy
OT  - tyrosine kinase inhibitors
COIS- The authors report no conflicts of interest in this work.
EDAT- 2022/10/07 06:00
MHDA- 2022/10/07 06:01
PMCR- 2022/09/28
CRDT- 2022/10/06 02:04
PHST- 2022/06/22 00:00 [received]
PHST- 2022/09/13 00:00 [accepted]
PHST- 2022/10/06 02:04 [entrez]
PHST- 2022/10/07 06:00 [pubmed]
PHST- 2022/10/07 06:01 [medline]
PHST- 2022/09/28 00:00 [pmc-release]
AID - 379591 [pii]
AID - 10.2147/OTT.S379591 [doi]
PST - epublish
SO  - Onco Targets Ther. 2022 Sep 28;15:1067-1078. doi: 10.2147/OTT.S379591. 
      eCollection 2022.