PMID- 38116673
OWN - NLM
STAT- MEDLINE
DCOM- 20240318
LR  - 20240326
IS  - 1743-9159 (Electronic)
IS  - 1743-9191 (Print)
IS  - 1743-9159 (Linking)
VI  - 110
IP  - 3
DP  - 2024 Mar 1
TI  - Clinical efficacy and biomarker analysis of neoadjuvant camrelizumab plus 
      chemotherapy for early-stage triple-negative breast cancer: a experimental 
      single-arm phase II clinical trial pilot study.
PG  - 1527-1536
LID - 10.1097/JS9.0000000000001011 [doi]
AB  - BACKGROUND: Triple-negative breast cancer (TNBC) is associated with a dismal 
      prognosis. Immune checkpoint inhibitors have shown promising antitumor activity 
      in neoadjuvant settings. This single-arm, phase II trial aimed to evaluate the 
      efficacy and safety of camrelizumab plus chemotherapy as the neoadjuvant therapy 
      (NAT) in early TNBC. METHODS: Patients received eight cycles of camrelizumab plus 
      nonplatinum-based chemotherapy. The primary endpoint was total pathological 
      complete response (pCR). Secondary endpoints included the breast pathological 
      complete response (bpCR), adverse events (AEs). Multiomics biomarkers were 
      assessed as exploratory objective. RESULTS: Twenty of 23 TNBC patients receiving 
      NAT underwent surgery, with the total pCR rate of 65% (13/20) and bpCR rate of 
      70% (14/20). Grade >/=3 treatment-related AEs were observed in 14 (60.9%) patients, 
      with the most common AE being neutropenia (65.2%). Tumor immune microenvironment 
      was analyzed between pCR and non-pCR samples before and after the NAT. Gene 
      expression profiling showed a higher immune infiltration in pCR patients than 
      non-pCR patients in pre-NAT samples. Through establishment of a predictive model 
      for the NAT efficacy, TAP1 and IRF4 were identified as the potential predictive 
      biomarkers for response to the NAT. Gene set enrichment analysis revealed the 
      glycolysis and hypoxia pathways were significantly activated in non-pCR patients 
      before the NAT, and this hypoxia was aggravated after the NAT. CONCLUSION: 
      Camrelizumab plus nonplatinum-based chemotherapy shows a promising pCR rate in 
      early-stage TNBC, with an acceptable safety profile. TAP1 and IRF4 may serve as 
      potential predictive biomarkers for response to the NAT. Aggravated hypoxia and 
      activated glycolysis after the NAT may be associated with the treatment 
      resistance.
CI  - Copyright (c) 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Zheng, Chunhui
AU  - Zheng C
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Liu, Yanbing
AU  - Liu Y
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Wang, Xue'er
AU  - Wang X
AD  - Tianjin Medical University Cancer Institute & Hospital, National Clinical 
      Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, 
      Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin.
FAU - Bi, Zhao
AU  - Bi Z
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Qiu, Pengfei
AU  - Qiu P
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Qiao, Guangdong
AU  - Qiao G
AD  - Breast Cancer Center, The Affiliated Yantai Yuhuangding Hospital of Qingdao 
      University, Yantai.
FAU - Bi, Xiang
AU  - Bi X
AD  - Breast Cancer Center, The Affiliated Yantai Yuhuangding Hospital of Qingdao 
      University, Yantai.
FAU - Shi, Zhiqiang
AU  - Shi Z
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Zhang, Zhaopeng
AU  - Zhang Z
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Chen, Peng
AU  - Chen P
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Sun, Xiao
AU  - Sun X
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Wang, Chunjian
AU  - Wang C
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
FAU - Zhu, Shiguang
AU  - Zhu S
AD  - Breast Cancer Center, The Affiliated Yantai Yuhuangding Hospital of Qingdao 
      University, Yantai.
FAU - Meng, Xiangjing
AU  - Meng X
AD  - Toxicology Research Center, Shandong Academy of Occupational Health and 
      Occupational Medicine, Shandong First Medical University & Shandong Academy of 
      Medical Sciences, Jinan.
FAU - Song, Yunjie
AU  - Song Y
AD  - Jiangsu Simcere Diagnostics Co., Ltd., Nanjing Simcere Medical Laboratory Science 
      Co., Ltd., The State Key Laboratory of Neurology and Oncology Drug Developmen, 
      Nanjing, China.
FAU - Qi, Yingxue
AU  - Qi Y
AD  - Jiangsu Simcere Diagnostics Co., Ltd., Nanjing Simcere Medical Laboratory Science 
      Co., Ltd., The State Key Laboratory of Neurology and Oncology Drug Developmen, 
      Nanjing, China.
FAU - Li, Lu
AU  - Li L
AD  - Jiangsu Simcere Diagnostics Co., Ltd., Nanjing Simcere Medical Laboratory Science 
      Co., Ltd., The State Key Laboratory of Neurology and Oncology Drug Developmen, 
      Nanjing, China.
FAU - Luo, Ningning
AU  - Luo N
AD  - Jiangsu Simcere Diagnostics Co., Ltd., Nanjing Simcere Medical Laboratory Science 
      Co., Ltd., The State Key Laboratory of Neurology and Oncology Drug Developmen, 
      Nanjing, China.
FAU - Wang, Yongsheng
AU  - Wang Y
AD  - Breast Cancer Center, Shandong Cancer Hospital and Institute, Shandong First 
      Medical University and Shandong Academy of Medical Sciences, Jinan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20240301
PL  - United States
TA  - Int J Surg
JT  - International journal of surgery (London, England)
JID - 101228232
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 73096E137E (camrelizumab)
SB  - IM
MH  - Humans
MH  - *Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Hypoxia/drug therapy/etiology
MH  - Neoadjuvant Therapy
MH  - Pilot Projects
MH  - Treatment Outcome
MH  - *Triple Negative Breast Neoplasms/drug therapy/pathology
MH  - Tumor Microenvironment
MH  - Female
PMC - PMC10942181
COIS- The authors declare that they have no competing interests. Sponsorships or 
      competing interests that may be relevant to content are disclosed at the end of 
      this article.
EDAT- 2023/12/20 06:42
MHDA- 2024/03/18 06:43
PMCR- 2024/03/15
CRDT- 2023/12/20 05:28
PHST- 2023/09/12 00:00 [received]
PHST- 2023/12/04 00:00 [accepted]
PHST- 2024/03/18 06:43 [medline]
PHST- 2023/12/20 06:42 [pubmed]
PHST- 2023/12/20 05:28 [entrez]
PHST- 2024/03/15 00:00 [pmc-release]
AID - 01279778-990000000-00909 [pii]
AID - IJS-D-23-01974 [pii]
AID - 10.1097/JS9.0000000000001011 [doi]
PST - epublish
SO  - Int J Surg. 2024 Mar 1;110(3):1527-1536. doi: 10.1097/JS9.0000000000001011.