Evidence map›Paper›PMID 37713657›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649.

Markus Moehler, Hong Xiao, Steven I Blum, Elena Elimova, David Cella, Kohei Shitara, Jaffer A Ajani, Yelena Y Janjigian, Marcelo Garrido, Lin Shen and 14 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society 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 NCT06490159 (Predicting Peripheral Neuropathy of Paclitaxel in Second-line Chemotherapy for Gastric Cancer), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
10.8field-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.

NCT06490159 recruitingnot on this map

Predicting Peripheral Neuropathy of Paclitaxel in Second-line Chemotherapy for Gastric Cancer

TypeobservationalSponsorCity of Hope Medical CenterRan2018 to 2028Enrolled150ConditionsGastric Cancer, Chemotherapy-induced Peripheral Neuropathy, Paclitaxel, RamucirumabArmsPaclitaxel
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Gastric Carcinoma: Diagnosis, Staging, and Treatment.Deutsches Arzteblatt international · 2026
    Guideline
  3. Trial
  4. 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
    Trial
  5. Effect of Chemotherapy Patient Education Using the Teach-Back Method on Symptom Management and Quality of Life: A Randomized Controlled Trial.Journal of cancer education : the official journal of the American Association for Cancer Education · 2025
    Trial
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  9. Review
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  11. Article
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  15. Observational
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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

24 authors at 16 institutions in 10 countries.

Markus MoehlerJohannes-Gutenberg University Clinic, Mainz, Germany.ORCID 0000-0003-4071-8562
Hong XiaoBristol Myers Squibb, Princeton, NJ.ORCID 0000-0002-0401-9222
Steven I BlumBristol Myers Squibb, Princeton, NJ.
Elena ElimovaPrincess Margaret Cancer Centre, Toronto, ON, Canada.
David CellaNorthwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0000-0002-9881-4541
Kohei ShitaraNational Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-5196-3630
Jaffer A AjaniThe University of Texas MD Anderson Cancer Center, Houston, TX.
Yelena Y JanjigianMemorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY.ORCID 0000-0002-5357-5858
Marcelo GarridoClinica San Carlos de Apoquindo, Pontificia Universidad Católica, Santiago, Chile.ORCID 0000-0001-8905-8986
Lin ShenDepartment of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China.ORCID 0000-0002-8798-4756
Kensei YamaguchiCancer Institute Hospital of JFCR, Tokyo, Japan.ORCID 0000-0001-6887-5709
Tianshu LiuZhongshan Hospital Fudan University, Shanghai, China.
Michael Schenker2Department of Medical Oncology, Sfantul Nectarie Oncology Center, Dolj, Romania.ORCID 0000-0003-2645-6391
Ruben Kowalyszyn3Instituto Multidiciplinario de Oncología, Clinica Viedma SA, Viedma, Argentina.ORCID 0000-0003-2672-7913
Arinilda Campos Bragagnoli4Fundacao Pio Xii Hosp Cancer De Barretos, Barretos, Brazil.
Ricardo Bruges5Internal Medicine, Clinical Oncology, Instituto Nacional de Cancerología Empresa Social del Estado, Bogotá, Colombia.
Vincenzo Montesarchio6Ospedale V. Monaldi, Naples, Italy.
Roberto Pazo-Cid7Hospital Universitario Miguel Servet, Zaragoza, Spain.ORCID 0000-0002-8026-7391
Shannon Hunter8RTI Health Solutions, Research Triangle Park, NC.ORCID 0000-0001-9435-7737
Eric DavenportRTI Health Solutions, Research Triangle Park, NC.ORCID 0000-0002-2461-7000
Jinyi WangRTI Health Solutions, Research Triangle Park, NC.ORCID 0000-0001-6013-1422
Kaoru KondoBristol Myers Squibb, Princeton, NJ.ORCID 0009-0008-7529-4791
Mingshun LiBristol Myers Squibb, Princeton, NJ.
Lucjan WyrwiczKlinika Onkologii i Radioterapii, Narodowy Instytut Onkologii, Warszawa, Poland.ORCID 0000-0003-0808-6892
Bristol-Myers Squibb (United States) · USRTI Health Solutions · USCentrum Onkologii · PLHospital de Câncer de Barretos · BRHospital Universitario Miguel Servet · ESInstituto Nacional de Cancerología · COJohannes Gutenberg University Mainz · DEMemorial Sloan Kettering Cancer Center · USNational Cancer Center Hospital East · JPNorthwestern University · USOspedale Monaldi · ITPeking University · CNPrincess Margaret Cancer Centre · CASun Yat-sen University · CNThe Cancer Institute Hospital · JPThe University of Texas MD Anderson Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeIn CheckMate 649, first-line nivolumab plus chemotherapy prolonged overall survival versus chemotherapy in patients with advanced/metastatic non-human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC). We present exploratory patient-reported outcomes (PROs).

methodsIn patients (N = 1,581) concurrently randomly assigned 1:1 to nivolumab plus chemotherapy or chemotherapy and in those with tumor PD-L1 expression at a combined positive score (CPS) of ≥5, health-related quality of life (HRQoL) was assessed using the EQ-5D and Functional Assessment of Cancer Therapy-Gastric (FACT-Ga), which included the FACT-General (FACT-G) and Gastric Cancer subscale (GaCS). The FACT-G GP5 item assessed treatment-related symptom burden. Longitudinal changes in HRQoL were assessed using mixed models for repeated measures in the PRO analysis population (randomly assigned patients with baseline and ≥1 postbaseline assessments). Time to symptom or definitive deterioration analyses were also conducted.

resultsIn the PRO analysis population (n = 1,360), PRO questionnaire completion rates were mostly >80% during treatment. Patient-reported symptom burden was not increased with nivolumab plus chemotherapy versus chemotherapy. Mean improved changes from baseline were greater with nivolumab plus chemotherapy versus chemotherapy for FACT-Ga total, GaCS, and EQ-5D visual analog scale in patients with a CPS of ≥5; results were similar for the overall PRO analysis population. In CPS ≥5 and all randomly assigned populations, nivolumab plus chemotherapy reduced the risk of symptom deterioration versus chemotherapy, on the basis of FACT-Ga total score and GaCS; time to definitive deterioration was longer, and the risk of definitive deterioration in HRQoL was reduced with nivolumab plus chemotherapy across EQ-5D and most FACT-Ga measures (hazard ratio [95% CI] <1).

conclusionCompared with chemotherapy alone, first-line nivolumab plus chemotherapy showed stable or better on-treatment HRQoL in patients with advanced/metastatic non-HER2-positive GC/GEJC/EAC and also showed decreased risk of definitive HRQoL deterioration.

Indexed as

AdenocarcinomaStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophagogastric JunctionHumansNivolumabQuality of LifeNivolumab

Identifiers

PMID37713657
PMCPMC10713185
OpenAlexW4386764738

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.