Evidence map›Paper›PMID 34371381›Full record

Trial reportESMO open2021

Quality of life with first-line pembrolizumab for PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma: results from the randomised phase III KEYNOTE-062 study.

E Van Cutsem, A Valderrama, Y-J Bang, C S Fuchs, K Shitara, Y Y Janjigian, S Qin, T G Larson, V Shankaran, S Stein and 4 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 5 pooled it
1.8field-weighted citation impact, top 14% 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

14 citing papers in PubMed, 5 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  7. Health-related quality-of-life outcomes with regorafenib in advanced gastric and esophagogastric junction cancer: results from the INTEGRATE trials.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
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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

14 authors at 10 institutions in 7 countries.

E Van CutsemDepartment of Digestive Oncology, University Hospital Gasthuisberg Leuven and KU Leuven, Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.
A ValderramaCenter for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, USA.
Y-J BangDepartment of Biomedical Research, Seoul National University College of Medicine, Seoul, South Korea.
C S FuchsDepartment of Internal Medicine: Hematology, Medical Oncology, Gastro-oncology, Yale University Cancer Center, Smilow Cancer Hospital, New Haven, USA.
K ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Y Y JanjigianDepartment of Gastrointestinal Oncology, Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
S QinCancer Center, PLA Cancer Centre of Nanjing Bayi Hospital, Nanjing, China.
T G LarsonDepartment of Hematology/Oncology, Minnesota Oncology Hematology, Minneapolis.
V ShankaranDepartment of Medical Oncology, Seattle Cancer Care Alliance, Seattle.
S SteinDepartment of Internal Medicine: Hematology, Medical Oncology, Gastro-oncology, Yale University Cancer Center, Smilow Cancer Hospital, New Haven, USA.
J M NorquistCenter for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, USA.
U KherDepartment of Medical Oncology, Merck & Co., Inc., Kenilworth, USA.
S ShahDepartment of Medical Oncology, Merck & Co., Inc., Kenilworth, USA.
M AlsinaDepartment of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology, Barcelona; University Autònoma de Barcelona, Barcelona, Spain.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USSmilow Cancer Hospital · US81th Hospital of PLA · CNHebron University · PSKU Leuven · BEMemorial Sloan Kettering Cancer Center · USMinnesota Oncology · USNational Cancer Center Hospital East · JPSeattle Cancer Care Alliance · USSeoul National University · KR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundIn the randomised phase III KEYNOTE-062 study, pembrolizumab was non-inferior to chemotherapy for overall survival in patients with programmed death-ligand 1 (PD-L1)-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (GEJ) cancer. We present findings of prespecified health-related quality-of-life (HRQOL) analyses for pembrolizumab versus chemotherapy in this population. MATERIALS AND

methodsHRQOL, a secondary endpoint, was measured in patients who received ≥1 dose of study treatment and completed ≥1 HRQOL questionnaire [European Organisation for the Research and Treatment of Cancer (EORTC) 30-question quality-of-life (QLQ-C30), EORTC 22-question quality-of-life gastric-cancer-specific module (QLQ-STO22)]. Least squares mean (LSM) change (baseline to week 18) in global health status/quality of life (GHS/QOL; EORTC QLQ-C30) and time to deterioration (TTD) in GHS/QOL, nausea/vomiting and appetite loss scores (EORTC QLQ-C30) and abdominal pain/discomfort scores (EORTC QLQ-STO22) were evaluated.

resultsThe HRQOL population comprised 495 patients with CPS ≥1 (pembrolizumab, 252; chemotherapy, 243). Compliance rates at week 18 were similar for pembrolizumab and chemotherapy (EORTC QLQ-C30, 87.9% and 81.9%; EORTC QLQ-STO22, 87.9% and 81.3%, respectively). There was no between-arm difference in LSM score change in GHS/QOL [-0.16; 95% confidence interval (CI) -5.01 to 4.69; P = 0.948]. The LSM score change for most subscales showed comparable worsening in both arms. TTD for GHS/QOL [hazard ratio (HR), 0.96; 95% CI, 0.67-1.38; P = 0.826], appetite loss (HR, 0.83; 95% CI, 0.58-1.20; P = 0.314) and pain (HR, 1.22; 95% CI, 0.78-1.91; P = 0.381) were similar between arms. Longer TTD was observed for pembrolizumab versus chemotherapy for nausea/vomiting (HR, 0.61; 95% CI, 0.44-0.85; P = 0.003).

conclusionsHRQOL was maintained with first-line treatment with pembrolizumab in patients with PD-L1-positive advanced gastric/GEJ cancer and was similar between pembrolizumab and chemotherapy in this population.

Indexed as

AdenocarcinomaQuality of LifeAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenEsophagogastric JunctionHumansAntibodies, Monoclonal, HumanizedB7-H1 Antigenpembrolizumabgastric cancergastroesophageal cancerpatient-reported outcomespembrolizumabquality of life

Identifiers

PMID34371381
PMCPMC8358416
OpenAlexW3192020910

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.