Evidence map›Paper›PMID 36533429›Full record

Trial reportJapanese journal of clinical oncology2023

Pembrolizumab or pembrolizumab plus chemotherapy versus standard of care chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062.

Hironaga Satake, Keun-Wook Lee, Hyun Cheol Chung, Jeeyun Lee, Kensei Yamaguchi, Jen-Shi Chen, Takaki Yoshikawa, Kenji Amagai, Kun-Huei Yeh, Masahiro Goto and 6 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02494583 (A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction), which is not on this map. Cited by 19 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 5 pooled it
2.0field-weighted citation impact, top 12% 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.

NCT02494583 phase3completednot on this map

A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2022Enrolled763ConditionsGastric AdenocarcinomaArmsPembrolizumab, Cisplatin, 5-FU, Capecitabine, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 5 syntheses or guidelines pooled it, 18 citations in OpenAlex.

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  14. Cold and hot tumors: from molecular mechanisms to targeted therapy.Signal transduction and targeted therapy · 2024
    Review
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  16. 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

16 authors at 14 institutions in 6 countries.

Hironaga SatakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe City, Japan and Department of Medical Oncology, Kochi Medical School, Kochi, Japan.ORCID 0000-0001-7629-6803
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Hyun Cheol ChungDepartment of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Jeeyun LeeDivision of Hematology/Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea.
Kensei YamaguchiDepartment of Gastroenterological Chemotherapy, The Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID 0000-0001-6887-5709
Jen-Shi ChenDivision of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan and College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.
Takaki YoshikawaDepartment of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.
Kenji AmagaiDepartment of Gastroenterology, Ibaraki Prefectural Central Hospital, Ibaraki, Japan.
Kun-Huei YehDepartment of Oncology, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
Yee ChaoDepartment of Oncology, Taipei Veterans General Hospital, Taipei City, Taiwan.
Ka-On LamDepartment of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.
Shi Rong HanDepartment of Medical Oncology, MSD K.K., Tokyo, Japan.
Shinichi ShiratoriDepartment of Medical Oncology, MSD K.K., Tokyo, Japan.
Sukrut ShahDepartment of Medical Oncology, Merck & Co., Inc., Rahway, NJ, USA.
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital, Kashiwa, Japan.
MSD K.K. (Japan) · JPChang Gung University · TWIbaraki Prefectural Central Hospital · JPKobe City Medical Center General Hospital · JPMerck & Co., Inc., Rahway, NJ, USA (United States) · USNational Cancer Center Hospital East · JPNational Taiwan University Hospital · TWQueen Mary Hospital · CNSamsung Medical Center · KRSeoul National University Bundang Hospital · KRTaipei Veterans General Hospital · TWThe Cancer Institute Hospital · JPTokyo National Hospital · JPYonsei University · KR

Funding

Merck Sharp & Dohme LLC
6 · The paper itself

Abstract

objectiveFirst-line pembrolizumab with/without chemotherapy versus chemotherapy was evaluated in programmed death ligand 1 combined positive score ≥1, locally advanced/unresectable or metastatic gastric cancer/gastrooesophageal junction cancer in the KEYNOTE-062 study. We present results for patients enrolled in Asia.

methodsEligible patients were randomly assigned 1:1:1 to pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin + 5-fluorouracil or capecitabine) or placebo plus chemotherapy Q3W. End points included overall survival (primary) in combined positive score ≥1 and combined positive score ≥10 populations and safety and tolerability (secondary).

resultsA total of 187 patients were enrolled in Asia (pembrolizumab, n = 62; pembrolizumab plus chemotherapy, n = 64; chemotherapy, n = 61). Compared with the global population, higher proportions of patients had Eastern Cooperative Oncology Group performance status 0 and a diagnosis of stomach cancer. In the programmed death ligand 1 combined positive score ≥1 population, median overall survival was numerically longer with pembrolizumab versus chemotherapy (22.7 vs 13.8 months; hazard ratio, 0.54; 95% confidence interval, 0.35-0.82) and pembrolizumab plus chemotherapy versus chemotherapy (16.5 vs 13.8 months; hazard ratio, 0.78; 95% confidence interval, 0.53-1.16). In the programmed death ligand 1 combined positive score ≥10 population, median overall survival was also numerically longer with pembrolizumab versus chemotherapy (28.5 vs 14.8 months; hazard ratio, 0.43; 95% confidence interval, 0.21-0.89) and pembrolizumab plus chemotherapy versus chemotherapy (17.5 vs 14.8 months; hazard ratio, 0.86; 95% confidence interval, 0.45-1.64). The grade 3-5 treatment-related adverse event rate was 19.4%, 75.8% and 64.9% for patients receiving pembrolizumab, pembrolizumab plus chemotherapy and chemotherapy, respectively.

conclusionsThis post hoc analysis showed pembrolizumab monotherapy was associated with numerically improved overall survival and a favourable tolerability profile versus chemotherapy in Asians with programmed death ligand 1-positive advanced gastric cancer/gastrooesophageal junction cancer.This study is registered with ClinicalTrials.gov, NCT02494583.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsStandard of CareStomach NeoplasmsAntibodies, Monoclonal, HumanizedAsianCisplatinEsophageal NeoplasmsEsophagogastric JunctionHumansAntibodies, Monoclonal, HumanizedCisplatinpembrolizumabAsian patientschemotherapygastric cancergastrooesophageal junction cancerpembrolizumab

Identifiers

PMID36533429
PMCPMC9991501
OpenAlexW4311931013

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.