Evidence map›Paper›PMID 38607538›Full record

Trial reportEsophagus : official journal of the Japan Esophageal Society2024

First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study.

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

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Esophagus : official journal of the Japan Esophageal Society, 2024. 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 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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.

Ken KatoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. kenkato@ncc.go.jp.ORCID 0000-0002-1733-5072
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, Miki, Kagawa, Japan.
Hisateru YasuiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.
Taroh SatohCenter for Cancer Genomics and Precision Medicine, Osaka University Hospital, Osaka, Japan.
Takashi OgataDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Kanagawa, 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, Matsuyama, Ehime, Japan.
ShiRong HanDepartment of Medical Oncology, MSD K.K., Tokyo, Japan.
Keiichi IwakamiDepartment of Medical Oncology, MSD K.K., Tokyo, Japan.
Naoyoshi YatsuzukaDepartment of Medical Oncology, MSD K.K., Tokyo, Japan.
Toshihiko DoiDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFirst-line pembrolizumab plus chemotherapy (pembrolizumab-chemotherapy) demonstrated improved efficacy and a manageable safety profile versus placebo plus chemotherapy (placebo-chemotherapy) in the subgroup analysis of Japanese patients with advanced/metastatic esophageal cancer in KEYNOTE-590 at a median follow-up of 24.4 months. Longer-term data from the Japanese subgroup analysis of KEYNOTE-590 are reported.

methodsPatients were randomly assigned 1:1 to pembrolizumab 200 mg or placebo every 3 weeks for ≤ 35 cycles plus chemotherapy (cisplatin 80 mg/m

resultsOverall, 141 patients were enrolled in Japan. As of July 9, 2021, median follow-up was 36.6 months (range, 29.8-45.7). Pembrolizumab-chemotherapy showed a trend toward favorable OS (hazard ratio [HR], 0.70; 95% confidence interval [CI] 0.47-1.03) and PFS (0.57; 0.39-0.83) versus placebo-chemotherapy. In the pembrolizumab-chemotherapy group, patients with ETS ≥ 20% (55/74; 74.3%) versus < 20% (19/74; 25.7%) had favorable OS (HR, 0.23; 95% CI 0.12-0.42) and PFS (0.24; 0.13-0.43). Patients with DpR ≥ 60% (31/74; 41.9%) versus < 60% (43/74; 58.1%) had favorable OS (HR, 0.37; 95% CI 0.20-0.68) and PFS (0.24; 0.13-0.43). Grade 3-5 treatment-related adverse events occurred in 55/74 patients (74.3%) with pembrolizumab-chemotherapy and 41/67 patients (61.2%) with placebo-chemotherapy.

conclusionsWith longer-term follow-up of Japanese patients with advanced/metastatic esophageal cancer, efficacy continued to favor pembrolizumab-chemotherapy compared with placebo-chemotherapy, with no new safety signals observed. CLINICAL

trial registrationClinicalTrials.gov, NCT03189719.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCisplatinEsophageal NeoplasmsFluorouracilAdultAgedAntineoplastic Agents, ImmunologicalDouble-Blind MethodEast Asian PeopleFemaleFollow-Up StudiesHumansJapanMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCisplatinFluorouracilpembrolizumabEsophageal squamous cell carcinomaImmune checkpoint inhibitorsImmunotherapyPembrolizumabProgrammed cell death ligand 1

Identifiers

PMID38607538
PMCPMC11199245

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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.