PMID- 34988209
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220429
IS  - 2305-5839 (Print)
IS  - 2305-5847 (Electronic)
IS  - 2305-5839 (Linking)
VI  - 9
IP  - 22
DP  - 2021 Nov
TI  - A multicenter single-arm trial of sintilimab in combination with chemotherapy for 
      neoadjuvant treatment of resectable esophageal cancer (SIN-ICE study).
PG  - 1700
LID - 10.21037/atm-21-6102 [doi]
LID - 1700
AB  - BACKGROUND: Preoperative chemotherapy or chemoradiotherapy is the standard 
      treatment for resectable esophageal cancer (EC); however, it is associated with 
      increased postoperative complications and mortality. Recently, Immune Checkpoint 
      inhibitors have been incorporated in the treatment of advanced EC. Its role in 
      the preoperative setting has not been established yet. In this multicenter, 
      single-arm study, we evaluated the efficacy and safety of neoadjuvant therapy 
      with sintilimab in combination with chemotherapy in treating EC. METHODS: 
      Patients received neoadjuvant therapy with 3 cycles of sintilimab 200 mg Q3W in 
      combination with platinum-based chemotherapy. Surgery was performed within 4-6 
      weeks after neoadjuvant therapy. The primary endpoints of the trial were 
      pathological complete response (pCR) and safety. RESULTS: A total of 23 patients 
      (21 men and 2 women) were enrolled. Surgery was completed in 17 participants, 
      with 16 achieving R0 resection and 1 had R1 resection, 5 participants refused 
      surgery. One patient progressed prior to surgery. Twenty one patients (91%) had 
      significant improvement in their dysphagia following treatment as assessed by 
      Stooler's criteria. The majority of patients who underwent resection have a good 
      pathological response and downstaging rate was 76.5% (13/17). A pCR was achieved 
      in 6 cases (6/17, 35.3%) and major pathological response (MPR) in 9 cases (9/17, 
      52.9%). The main preoperative adverse events (AEs) were vomiting (13/23, 56.5%), 
      leukopenia (12/23, 52.2%), neutropenia (9/23, 39.1%), and malaise (8/23, 34.8%). 
      Immune-related AEs were mild and included hypothyroidism (2/23, 8.7%) and rash 
      (4/23, 17.4%). The incidence of >/= grade 3 treatment related AEs was 30.4% (7/23). 
      There were no >/= grade 4 AEs. CONCLUSIONS: Sintilimab in combination with 
      chemotherapy in the neoadjuvant treatment of EC is safe and lead to a high pCR. 
      Therefore, further testing is warranted.
CI  - 2021 Annals of Translational Medicine. All rights reserved.
FAU - Duan, Hongtao
AU  - Duan H
AD  - Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, 
      Xi'an, China.
FAU - Wang, Tianhu
AU  - Wang T
AD  - Department of Thoracic Surgery, Third Affiliated Hospital, Chongqing Medical 
      University, Chongqing, China.
FAU - Luo, Zhilin
AU  - Luo Z
AD  - Department of Thoracic Surgery, Third Affiliated Hospital, Chongqing Medical 
      University, Chongqing, China.
FAU - Wang, Xiaoyuan
AU  - Wang X
AD  - Thoracic Surgery Department, Harbin Medical University Cancer Hospital, Harbin, 
      China.
FAU - Liu, Honggang
AU  - Liu H
AD  - Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, 
      Xi'an, China.
FAU - Tong, Liping
AU  - Tong L
AD  - Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, 
      Xi'an, China.
FAU - Dong, Xiaoping
AU  - Dong X
AD  - Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, 
      Xi'an, China.
FAU - Zhang, Yong
AU  - Zhang Y
AD  - Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, 
      Xi'an, China.
FAU - Valmasoni, Michele
AU  - Valmasoni M
AD  - Department of Surgery, Oncology and Gastroenterology, School of Medicine, 
      University of Padova, Padova, Italy.
FAU - Kidane, Biniam
AU  - Kidane B
AD  - Section of Thoracic Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.
FAU - Almhanna, Khaldoun
AU  - Almhanna K
AD  - Division of Hematology/Oncology, The Warren Alpert Medical School of Brown 
      University, Lifespan Cancer Institute, Rhode Island Hospital, Providence, RI, 
      USA.
FAU - Wiesel, Ory
AU  - Wiesel O
AD  - Division of Foregut and Thoracic Surgery, Department of Surgery, Rabin Medical 
      Center, Beilinson Hospital, Petah Tikva, Israel.
FAU - Pang, Sainan
AU  - Pang S
AD  - Thoracic Surgery Department, Harbin Medical University Cancer Hospital, Harbin, 
      China.
FAU - Ma, Jianqun
AU  - Ma J
AD  - Thoracic Surgery Department, Harbin Medical University Cancer Hospital, Harbin, 
      China.
FAU - Yan, Xiaolong
AU  - Yan X
AD  - Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, 
      Xi'an, China.
LA  - eng
PT  - Journal Article
PL  - China
TA  - Ann Transl Med
JT  - Annals of translational medicine
JID - 101617978
PMC - PMC8667140
OTO - NOTNLM
OT  - Sintilimab
OT  - efficacy
OT  - major pathological response (MPR)
OT  - pathological complete response (pCR)
OT  - safety
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at https://dx.doi.org/10.21037/atm-21-6102). The authors have no 
      conflicts of interest to declare.
EDAT- 2022/01/07 06:00
MHDA- 2022/01/07 06:01
PMCR- 2021/11/01
CRDT- 2022/01/06 06:00
PHST- 2021/08/26 00:00 [received]
PHST- 2021/11/24 00:00 [accepted]
PHST- 2022/01/06 06:00 [entrez]
PHST- 2022/01/07 06:00 [pubmed]
PHST- 2022/01/07 06:01 [medline]
PHST- 2021/11/01 00:00 [pmc-release]
AID - atm-09-22-1700 [pii]
AID - 10.21037/atm-21-6102 [doi]
PST - ppublish
SO  - Ann Transl Med. 2021 Nov;9(22):1700. doi: 10.21037/atm-21-6102.