Evidence map›Paper›PMID 30911859›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019

Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study.

Yung-Jue Bang, Yoon-Koo Kang, Daniel V Catenacci, Kei Muro, Charles S Fuchs, Ravit Geva, Hiroki Hara, Talia Golan, Marcelo Garrido, Shadia I Jalal and 9 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 162 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
162citing papers in PubMed, 16 pooled it
27.9field-weighted citation impact, top 1% 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.

NCT02335411 phase2completednot on this map

A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil in Subjects With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2021Enrolled318ConditionsGastric Adenocarcinoma, Gastroesophageal Junction AdenocarcinomaArmspembrolizumab, cisplatin, 5-FU, capecitabine
NCT05025033 phase2completednot on this map

Chemotherapy Combined With Apatinib and PD-1 Monoclonal Antibody for Second-line or Above Treatment of Advanced Gastric Cancer-A Prospective, Single-arm, Open, Phase II Study

TypeinterventionalSponsorTianjin Medical University Cancer Institute and HospitalRan2019 to 2022Enrolled30ConditionsGastric CancerArmsPD-1 antibody, paclitaxel or irinotecan, Apatinib mesylate
NCT06576921 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial

TypeinterventionalSponsorXijing HospitalRan2024 to 2026Enrolled116ConditionsStomach Neoplasms, Immune Checkpoint InhibitorsArmsSerplulimab Combined With Chemotherapy, Placebo combined with Chemotherapy
3 · Its place in the literature

Who cites it

162 citing papers in PubMed, 16 syntheses or guidelines pooled it, 243 citations in OpenAlex.

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102 more citing papers are in PubMed but not listed here.

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 at 15 institutions in 8 countries.

Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea. bangyj@snu.ac.kr.
Yoon-Koo KangDivision of Oncology, Department of Internal Medicine, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea.
Daniel V CatenacciSection of Hematology/Oncology, Department of Medicine, University of Chicago Medicine, Chicago, IL, USA.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.
Charles S FuchsDepartment of Medical Oncology, Yale Cancer Center, New Haven, CT, USA.
Ravit GevaDepartment of Oncology, Tel-Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Talia GolanDepartment of Oncology, The Oncology Institute at the Chaim Sheba Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Marcelo GarridoHematology and Medical Oncology, Pontificia Universidad Católica de Chile, Santiago, Chile.
Shadia I JalalDepartment of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
Christophe BorgDepartment of Medical Oncology, University Hospital of Besançon, Besancon, France.
Toshihiko DoiDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Kashiwa, Japan.
Harry H YoonDepartment of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
Mary J SavageMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
Jiangdian WangMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
Rita P DalalMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
Sukrut ShahMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
Zev A WainbergDivision of Hematology Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Hyun Cheol ChungDivision of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USTel Aviv University · ILAichi Cancer Center · JPAsan Medical Center · KRCentre Hospitalier Universitaire de Besançon · FRIndiana University School of MedicineMayo Clinic in Arizona · USNational Cancer Center Hospital East · JPPontificia Universidad Católica de Chile · CLSaitama Cancer Center · JPSeoul National University · KRUniversity of California, Los Angeles · USUniversity of Chicago · USYale Cancer Center · USYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented.

methodsPatients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/m

resultsIn the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8-24.1) and 17.5 months (range 1.7-20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3-5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7-78.9] (combination therapy) and 25.8% (95% CI 11.9-44.6) (monotherapy).

conclusionsPembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma. CLINICAL TRIAL: ClinicalTrials.gov NCT02335411.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCarcinoma, Signet Ring CellCisplatinCohort StudiesEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilFollow-Up StudiesHumansAntibodies, Monoclonal, HumanizedCapecitabineCisplatinFluorouracilpembrolizumab5-FluorouracilCapecitabineCisplatinGastric cancerPembrolizumab

Identifiers

PMID30911859
PMCPMC6570680
OpenAlexW2934520391

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.