Evidence map›Paper›PMID 34988209›Full record

ArticleAnnals of translational medicine2021

A multicenter single-arm trial of sintilimab in combination with chemotherapy for neoadjuvant treatment of resectable esophageal cancer (SIN-ICE study).

Hongtao Duan, Tianhu Wang, Zhilin Luo, Xiaoyuan Wang, Honggang Liu, Liping Tong, Xiaoping Dong, Yong Zhang, Michele Valmasoni, Biniam Kidane and 5 more

Open access · diamondAbstract read
In one paragraph

Article in Annals of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
10.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 5 countries.

Hongtao Duan *Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Tianhu Wang *Department of Thoracic Surgery, Third Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Zhilin Luo *Department of Thoracic Surgery, Third Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Xiaoyuan Wang *Thoracic Surgery Department, Harbin Medical University Cancer Hospital, Harbin, China.
Honggang LiuDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Liping TongDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Xiaoping DongDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Yong ZhangDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Michele ValmasoniDepartment of Surgery, Oncology and Gastroenterology, School of Medicine, University of Padova, Padova, Italy.
Biniam KidaneSection of Thoracic Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.
Khaldoun AlmhannaDivision of Hematology/Oncology, The Warren Alpert Medical School of Brown University, Lifespan Cancer Institute, Rhode Island Hospital, Providence, RI, USA.
Ory WieselDivision of Foregut and Thoracic Surgery, Department of Surgery, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.
Sainan PangThoracic Surgery Department, Harbin Medical University Cancer Hospital, Harbin, China.
Jianqun MaThoracic Surgery Department, Harbin Medical University Cancer Hospital, Harbin, China.
Xiaolong YanDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Air Force Medical University · CNChongqing Medical University · CNHarbin Medical University · CNLifespan · USRabin Medical Center · ILThird Affiliated Hospital of Harbin Medical University · CNUniversity of Manitoba · CAUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreoperative 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.

methodsPatients 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.

resultsA 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.

conclusionsSintilimab in combination with chemotherapy in the neoadjuvant treatment of EC is safe and lead to a high pCR. Therefore, further testing is warranted.

Indexed as

efficacymajor pathological response (MPR)pathological complete response (pCR)safetySintilimab

Identifiers

PMID34988209
PMCPMC8667140
OpenAlexW3216388079

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.