Evidence map›Paper›PMID 35668304›Full record

Trial reportEsophagus : official journal of the Japan Esophageal Society2022

First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590.

Takashi Kojima, Hiroki Hara, Akihito Tsuji, Hisateru Yasui, Kei Muro, Taroh Satoh, Takashi Ogata, Ryu Ishihara, Masahiro Goto, Hideo Baba and 6 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Esophagus : official journal of the Japan Esophageal Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03189719 (A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
7.6field-weighted citation impact, top 2% 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.

NCT03189719 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2023Enrolled749ConditionsEsophageal NeoplasmsArmsPembrolizumab, Placebo, Cisplatin, 5-FU
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 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

16 authors at 12 institutions in 2 countries.

Takashi KojimaDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Akihito TsujiDepartment of Medical Oncology, Kagawa University Hospital, Kagawa, Japan.
Hisateru YasuiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
Taroh SatohDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Hospital, Osaka, Japan.
Takashi OgataDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Ryu IshiharaDepartment of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Kumamoto University Hospital, Kumamoto, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Shirong HanDepartment of Medical Oncology, MSD K.K, Tokyo, Japan.
Tomoko SakataDepartment of Medical Oncology, MSD K.K, Tokyo, Japan.
Naoyoshi YatsuzukaDepartment of Medical Oncology, MSD K.K, Tokyo, Japan.
Toshihiko DoiDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Ken KatoDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. kenkato@ncc.go.jp.ORCID 0000-0002-1733-5072
MSD K.K. (Japan) · JPNational Cancer Center Hospital East · JPAichi Cancer Center · JPKagawa University Hospital · JPKanagawa Prefectural Hospital Organization · JPKobe City Medical Center General Hospital · JPKumamoto University Hospital · JPNational Cancer Center · USOsaka International Cancer Institute · JPOsaka University Hospital · JPSaitama Cancer Center · JPShikoku Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase 3 KEYNOTE-590 (NCT03189719) study showed first-line pembrolizumab plus chemotherapy significantly prolonged overall survival and progression-free survival versus placebo plus chemotherapy in patients with advanced unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type I adenocarcinoma of the esophagogastric junction. We describe a subgroup analysis of Japanese patients from KEYNOTE-590.

methodsEligible patients were randomly assigned 1:1 to pembrolizumab 200 mg intravenously every 3 weeks or placebo plus chemotherapy (cisplatin 80 mg/m

resultsAt data cutoff (July 2, 2020), 141 Japanese patients were randomly assigned (pembrolizumab plus chemotherapy, 74; placebo plus chemotherapy, 67). In all Japanese patients, median overall survival was 17.6 months with pembrolizumab plus chemotherapy versus 11.7 months with chemotherapy (hazard ratio, 0.71; 95% confidence interval, 0.47-1.09), median progression-free survival was 6.3 versus 6.0 months (hazard ratio, 0.58; 95% confidence interval, 0.40-0.84), and objective response rate was 56.8% versus 38.8%. Grade 3-5 treatment-related adverse events were 74.3% and 61.2%.

conclusionFirst-line pembrolizumab plus chemotherapy demonstrated improvement in overall survival and progression-free survival compared with placebo plus chemotherapy in Japanese patients with advanced/metastatic esophageal cancer; safety was comparable between treatment groups. CLINICAL TRIAL REGISTRY: ClinicalTrials.gov, NCT03189719.

Indexed as

AdenocarcinomaEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansJapanAntibodies, Monoclonal, HumanizedpembrolizumabEsophageal squamous cell carcinomaImmune checkpoint inhibitorsImmunotherapyPembrolizumabProgrammed death ligand 1

Identifiers

PMID35668304
PMCPMC9436840
OpenAlexW4281621907

What OpenQuestion holds

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Registered trials

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.