PMID- 33760397
OWN - NLM
STAT- MEDLINE
DCOM- 20211207
LR  - 20211214
IS  - 1759-7714 (Electronic)
IS  - 1759-7706 (Print)
IS  - 1759-7706 (Linking)
VI  - 12
IP  - 9
DP  - 2021 May
TI  - SHR-1316, an anti-PD-L1 antibody, plus chemotherapy as the first-line treatment 
      for advanced esophageal squamous cell carcinoma: A multicentre, phase 2 study.
PG  - 1373-1381
LID - 10.1111/1759-7714.13913 [doi]
AB  - BACKGROUND: This multicentre, open-label study evaluated the efficacy and safety 
      of antiprogrammed death ligand 1 antibody SHR-1316 plus liposomal irinotecan and 
      5-fluorouracil as the first-line treatment for patients with advanced esophageal 
      squamous cell carcinoma (ESCC). METHODS: Eligible patients received SHR-1316 (10 
      mg/kg), liposomal irinotecan (60 mg/m(2) for the first cycle, 80 mg/m(2) 
      thereafter), and 5-fluorouracil (2400 mg/m(2) ) every 14 days until disease 
      progression, intolerable toxicity or withdrawal of consent. The primary endpoint 
      was progression-free survival (PFS). Secondary endpoints were objective response 
      rate (ORR), disease control rate (DCR), overall survival (OS), and safety. 
      RESULTS: We enrolled 23 patients between 11 March 2019 and 31 May 2019. The 
      median follow-up duration was 15.2 months (95% CI 14.2-16.2). The median PFS was 
      8.5 months (95% CI 1.2-15.8), and ORR and DCR were 52.2% (95% CI 30.1-74.3) and 
      73.9% (95% CI 54.5-93.3), respectively. The median OS was 11.6 months (95% CI 
      6.7-16.6). The most common treatment-related grade 3-4 adverse events (AEs) were 
      neutropenia (17.4%), nausea (13.0%), and anorexia (13.0%). Treatment-related 
      serious AEs occurred in two patients. No treatment-related deaths occurred. 
      CONCLUSIONS: SHR-1316 plus liposomal irinotecan and 5-fluorouracil has a 
      promising efficacy and manageable safety profile, and could be a new first-line 
      treatment approach for patients with unresectable locally advanced or distant 
      metastatic ESCC.
CI  - (c) 2021 The Authors. Thoracic Cancer published by China Lung Oncology Group and 
      John Wiley & Sons Australia, Ltd.
FAU - Mu, Lan
AU  - Mu L
AD  - Department of Medical Oncology, National Cancer Center/National Clinical Research 
      Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking 
      Union Medical College, Beijing, China.
FAU - Song, Yan
AU  - Song Y
AD  - Department of Medical Oncology, National Cancer Center/National Clinical Research 
      Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking 
      Union Medical College, Beijing, China.
FAU - Zhao, Kuaile
AU  - Zhao K
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
FAU - Liu, Ying
AU  - Liu Y
AD  - Department of Medical Oncology of Henan Cancer Hospital, Zhengzhou University 
      Affiliated Cancer Hospital, Zhengzhou, China.
FAU - Fan, Qingxia
AU  - Fan Q
AD  - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
FAU - Wang, Xi
AU  - Wang X
AD  - Department of Medical Oncology, National Cancer Center/National Clinical Research 
      Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking 
      Union Medical College, Beijing, China.
FAU - Li, Qun
AU  - Li Q
AD  - Department of Medical Oncology, National Cancer Center/National Clinical Research 
      Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking 
      Union Medical College, Beijing, China.
FAU - Wang, Xiaopeng
AU  - Wang X
AD  - Department of Clinical Medicine, Jiangsu Hengrui Medicine Co. Ltd, Lianyungang, 
      China.
FAU - Huang, Jing
AU  - Huang J
AUID- ORCID: 0000-0002-2167-8385
AD  - Department of Medical Oncology, National Cancer Center/National Clinical Research 
      Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking 
      Union Medical College, Beijing, China.
AD  - National Cancer Center/National Clinical Research Center for Cancer/Cancer 
      Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking 
      Union Medical College, Shenzhen, China.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210324
PL  - Singapore
TA  - Thorac Cancer
JT  - Thoracic cancer
JID - 101531441
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/pharmacology/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/pharmacology/*therapeutic use
MH  - Esophageal Squamous Cell Carcinoma/*drug therapy/mortality/pathology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Progression-Free Survival
MH  - Prospective Studies
MH  - Young Adult
PMC - PMC8088918
OTO - NOTNLM
OT  - anti-PD-L1 antibody
OT  - chemotherapy
OT  - esophageal squamous cell carcinoma
OT  - liposomal irinotecan
COIS- Xiaopeng Wang is an employee of Jiangsu Hengrui Medicine Co. Ltd. The other 
      authors declare no competing interests.
EDAT- 2021/03/25 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/05/01
CRDT- 2021/03/24 13:15
PHST- 2021/02/14 00:00 [revised]
PHST- 2021/01/29 00:00 [received]
PHST- 2021/02/14 00:00 [accepted]
PHST- 2021/03/25 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/03/24 13:15 [entrez]
PHST- 2021/05/01 00:00 [pmc-release]
AID - TCA13913 [pii]
AID - 10.1111/1759-7714.13913 [doi]
PST - ppublish
SO  - Thorac Cancer. 2021 May;12(9):1373-1381. doi: 10.1111/1759-7714.13913. Epub 2021 
      Mar 24.