Evidence map›Paper›PMID 37399357›Full record

Trial reportJournal for immunotherapy of cancer2023

Association between gene expression signatures and clinical outcomes of pembrolizumab versus paclitaxel in advanced gastric cancer: exploratory analysis from the randomized, controlled, phase III KEYNOTE-061 trial.

Kohei Shitara, Maria Di Bartolomeo, Mario Mandala, Min-Hee Ryu, Christian Caglevic, Tomasz Olesinski, Hyun Cheol Chung, Kei Muro, Eray Goekkurt, Raymond S McDermott and 9 more

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

Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02370498 (A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT02370498 phase3completednot on this map

A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2021Enrolled592ConditionsGastric Adenocarcinoma, Gastroesophageal Junction AdenocarcinomaArmspembrolizumab, paclitaxel
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Predictors of immunotherapy response in gastric cancer: the role of the tumor microenvironment and integrative predictive models.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  4. Review
  5. Article
  6. Review
  7. PD-L1 Expression in NSCLC: Clouds in a Bright Sky.International journal of molecular sciences · 2025
    Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
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

19 authors.

Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan kshitara@east.ncc.go.jp.ORCID 0000-0001-5196-3630
Maria Di BartolomeoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Mario MandalaUnit of Medical Oncology, University of Perugia, Perugia, Italy.ORCID 0000-0001-8846-8959
Min-Hee RyuDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea (the Republic of).
Christian CaglevicCancer Research Department, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago, Chile.
Tomasz OlesinskiDepartment of Gastrointestinal Cancers and Neuroendocrine Tumors Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.ORCID 0000-0001-6492-4331
Hyun Cheol ChungDivision of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea (the Republic of).
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Eray GoekkurtHematology-Oncology Practice Eppendorf (HOPE) and University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Raymond S McDermottSt Vincent's University Hospital & Cancer Trials, Dublin, Ireland.
Wasat MansoorChristie Hospital NHS Foundation Trust, University of Manchester, Manchester, UK.
Zev A WainbergDivision of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Chie-Schin ShihMerck & Co Inc, Rahway, New Jersey, USA.
Julie KobieMerck & Co Inc, Rahway, New Jersey, USA.
Michael NebozhynMerck & Co Inc, Rahway, New Jersey, USA.
Razvan CristescuMerck & Co Inc, Rahway, New Jersey, USA.
Z Alexander CaoMerck & Co Inc, Rahway, New Jersey, USA.
Andrey LobodaMerck & Co Inc, Rahway, New Jersey, USA.
Mustafa ÖzgüroğluDivision of Medical Oncology, Clinical Trial Unit, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Istanbul, Turkey.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the randomized, controlled, phase III KEYNOTE-061 trial, second-line pembrolizumab did not significantly prolong overall survival (OS) versus paclitaxel in patients with PD-L1-positive (combined positive score ≥1) advanced gastric/gastroesophageal junction (G/GEJ) cancer but did elicit a longer duration of response and offered a favorable safety profile. This prespecified exploratory analysis was conducted to evaluate associations between tumor gene expression signatures and clinical outcomes in the phase III KEYNOTE-061 trial.

methodsUsing RNA sequencing data obtained from formalin-fixed, paraffin-embedded baseline tumor tissue samples, we evaluated the 18-gene T-cell-inflamed gene expression profile (Tcell

resultsRNA sequencing data were available for 137 patients in each treatment group. Tcell

conclusionsThis exploratory analysis of tumor Tcell TRIAL REGISTRATION NUMBER: NCT02370498.

Indexed as

PaclitaxelStomach NeoplasmsAntibodies, Monoclonal, HumanizedHumansTranscriptomeAntibodies, Monoclonal, HumanizedPaclitaxelpembrolizumabGastrointestinal NeoplasmsGene Expression ProfilingGenetic MarkersImmunotherapyProgrammed Cell Death 1 Receptor

Identifiers

PMID37399357
PMCPMC10314681

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.