Evidence map›Paper›PMID 35701865›Full record

Trial reportCancer science2022

Phase IIb study of pembrolizumab combined with S-1 + oxaliplatin or S-1 + cisplatin as first-line chemotherapy for gastric cancer.

Kensei Yamaguchi, Keiko Minashi, Daisuke Sakai, Tomohiro Nishina, Yasushi Omuro, Masahiro Tsuda, Shiroh Iwagami, Hisato Kawakami, Taito Esaki, Naotoshi Sugimoto and 13 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 6% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  15. Immunotherapy for advanced gastric cancer.World journal of methodology · 2023
    Review
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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

23 authors at 20 institutions in 2 countries.

Kensei YamaguchiDepartment of Gastroenterological Chemotherapy, The Cancer Institute Hospital of Japanese Foundation for Cancer, Tokyo, Japan.
Keiko MinashiClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Daisuke SakaiDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Yasushi OmuroDepartment of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Masahiro TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.
Shiroh IwagamiDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Hisato KawakamiDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, Japan.ORCID https://orcid.org/0000-0002-3280-4850
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Naotoshi SugimotoDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Takashi OshimaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Ken KatoDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1733-5072
Kenji AmagaiDepartment of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan.
Hisashi HosakaDepartment of Gastroenterology, Gunma Prefectural Cancer Center, Ota, Japan.
Keigo KomineDepartment of Medical Oncology, Tohoku University Hospital, Sendai, Japan.
Hisateru YasuiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Yuji NegoroDepartment of Gastroenterology, Kochi Health Sciences Center, Kochi, Japan.
Kenji IshidoDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.
Takahiro TsushimaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto, Japan.
Shirong HanBiostatistics and Research Decision Sciences, MSD K.K., Tokyo, Japan.
Shinichi ShiratoriOncology Science Unit, MSD K.K., Tokyo, Japan.
Tomoko TakamiOncology Science Unit, MSD K.K., Tokyo, Japan.
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID https://orcid.org/0000-0001-5196-3630
MSD K.K. (Japan) · JPNational Cancer Center Hospital East · JPChiba Cancer Center · JPGunma Prefectural Cardiovascular Center · JPHyogo Prefectural Cancer Center · JPIbaraki Prefectural Central Hospital · JPKanagawa Prefectural Hospital Organization · JPKindai University · JPKitasato University · JPKobe City Medical Center General Hospital · JPKumamoto University · JPNational Hospital Organization Kyushu Cancer Center · JPOsaka International Cancer Institute · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPThe Cancer Institute Hospital · JPThe University of Osaka · JPTohoku University Hospital · JPTokyo Metropolitan Komagome Hospital · JPUniversity of Kochi · JP

Funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.Taiho Pharmaceutical
6 · The paper itself

Abstract

The KEYNOTE-659 study evaluated the efficacy and safety of first-line pembrolizumab plus S-1 and oxaliplatin (SOX) (cohort 1) or S-1 and cisplatin (SP) (cohort 2) for advanced gastric/gastroesophageal junction (G/GEJ) cancer in Japan. Herein, we update the results of cohort 1 and describe the results of cohort 2. This open-label phase IIb study enrolled patients with advanced programmed death-ligand 1 (PD-L1)-positive (combined positive score ≥ 1) human epidermal growth factor receptor 2 (HER2)-negative G/GEJ adenocarcinoma. The primary end-point was the objective response rate (ORR). Other end-points were duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. One hundred patients were enrolled. In cohorts 1 and 2, median follow-up time was 16.9 and 17.1 months; ORR (central review), 72.2% and 80.4%; DOR, 10.6 and 9.5 months; DCR (central review), 96.3% and 97.8%; median PFS (central review), 9.4 and 8.3 months; and median OS, 16.9 and 17.1 months, respectively. Treatment-related adverse events (TRAEs) occurred in all patients, including peripheral sensory neuropathy (94.4%, cohort 1), decreased neutrophil count (82.6%, cohort 2), nausea (59.3% and 60.9% in cohorts 1 and 2), and decreased appetite (61.1% and 60.9% in cohorts 1 and 2). Grade 3 or higher TRAEs were reported by 59.3% (cohort 1) and 78.3% (cohort 2), including decreased platelet count (14.8%, cohort 1) and decreased neutrophil count (52.2%, cohort 2). Pembrolizumab in combination with SOX or SP showed favorable efficacy and safety in patients with PD-L1-positive, HER2-negative G/GEJ adenocarcinoma.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsStomach NeoplasmsAntibodies, Monoclonal, HumanizedB7-H1 AntigenCisplatinEsophageal NeoplasmsHumansOxaliplatinAntibodies, Monoclonal, HumanizedB7-H1 AntigenCisplatinOxaliplatinpembrolizumabcisplatingastric canceroxaliplatinpembrolizumabS-1

Identifiers

PMID35701865
PMCPMC9357620
OpenAlexW4282933038

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.