Evidence map›Paper›PMID 35720388›Full record

Trial reportFrontiers in immunology2022

Neoadjuvant Pembrolizumab and Chemotherapy in Resectable Esophageal Cancer: An Open-Label, Single-Arm Study (PEN-ICE).

Hongtao Duan, Changjian Shao, Minghong Pan, Honggang Liu, Xiaoping Dong, Yong Zhang, Liping Tong, Yingtong Feng, Yuanyuan Wang, Lu Wang and 7 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Frontiers in immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 4 pooled it
10.7field-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

44 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 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

17 authors at 6 institutions in 4 countries.

Hongtao DuanDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Changjian ShaoDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Minghong PanDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Honggang LiuDepartment 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.
Liping TongDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Yingtong FengDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Yuanyuan WangDepartment of Pathology, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Lu WangDepartment of Pathology, Xijing Hospital, Air Force Medical University, Xi'an, China.
Neil B NewmanDepartment of Radiation Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, United States.
Inderpal S SarkariaDepartment of Cardiothoracic Surgery, The University of Pittsburgh School of Medicine and the University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
John V ReynoldsDepartment of Surgery, Trinity Centre, St. James's Hospital, Dublin, Ireland.
Francesco De CobelliDepartment of Radiology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Zhiqiang MaDepartment of Medical Oncology, Senior Department of Oncology, The Fifth Medical Center of PLA General Hospital, Beijing, China.
Tao JiangDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Xiaolong YanDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, Xi'an, China.
Air Force Medical University · CNChinese PLA General Hospital · CNIstituti di Ricovero e Cura a Carattere Scientifico · ITSt. James's Hospital · IEUniversity of Pittsburgh Medical Center · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In this single-arm study, the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy were evaluated in patients with resectable esophageal squamous cell carcinoma (ESCC). Methods: This study included patients with ESCC of clinical stages II-IVA who underwent surgery within 4 to 6 weeks after completing treatment with pembrolizumab (200 mg) combined with a conventional chemotherapy regimen (3 cycles). The safety and efficacy of this combination treatment were evaluated as primary endpoints of the study. Results: From April 2019 to August 2020, a total of 18 patients (including 14 men) were enrolled, of whom 13 patients progressed to surgery. Postoperative pathology revealed a major pathological response (MPR) in 9 cases (9/13, 69.2%) and a pathological complete response (pCR) in 6 cases (6/13, 46.2%). Five patients (5/18, 27.8%) experienced serious treatment-related adverse events (AEs) of grades 3-4. At the time of data cutoff (Mar 25, 2022), the shortest duration of follow-up was 17.8 months. Programmed death-ligand 1 (PD-L1) expression in pretreatment specimens was not significantly associated with the percentage of residual viable tumor (RVT) (r=-0.55, P=0.08). Changes in counts of CD68 Conclusions: The combination of neoadjuvant immunotherapy and chemotherapy for ESCC is associated with a high pathological response and immunologic effects in the tumor microenvironment (TME). It has acceptable toxicity and great efficacy, suggesting a strong rationale for its further evaluation in randomized clinical trials (RCTs). Trial Registration: ChiCTR2100048917.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaAntibodies, Monoclonal, HumanizedFemaleHumansMaleNeoadjuvant TherapyTumor MicroenvironmentAntibodies, Monoclonal, Humanizedpembrolizumabchemotherapyefficacymajor pathological response (MPR)pathological complete response (pCR)Pembrolizumabresectable esophageal cancersafety

Identifiers

PMID35720388
PMCPMC9202755
OpenAlexW4281687363

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.