Evidence map›Paper›PMID 33755863›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2021

Patient-reported outcomes from the phase II FAST trial of zolbetuximab plus EOX compared to EOX alone as first-line treatment of patients with metastatic CLDN18.2+ gastroesophageal adenocarcinoma.

Florian Lordick, Salah-Eddin Al-Batran, Arijit Ganguli, Robert Morlock, Ugur Sahin, Özlem Türeci

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  6. Effects ofWorld journal of gastrointestinal surgery · 2025
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  12. [European journal of nuclear medicine and molecular imaging · 2024
    Article
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  16. Claudin18.2 expression in pulmonary mucinous adenocarcinoma.Journal of cancer research and clinical oncology · 2023
    Article
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  20. Claudin18.2-targeted cancer theranostics.American journal of nuclear medicine and molecular imaging · 2023
    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

6 authors at 4 institutions in 2 countries.

Florian LordickUniversity of Leipzig Medical Center, University Cancer Center (UCCL), Leipzig, Germany. florian.lordick@medizin.uni-leipzig.de.
Salah-Eddin Al-BatranInstitut für Klinische Krebsforschung IKF Am Krankenhaus Nordwest, Frankfurt, Germany.
Arijit GanguliAstellas Pharma, Inc, Northbrook, IL, USA.
Robert MorlockYourCareChoice, Ann Arbor, MI, USA.
Ugur SahinTRON - Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
Özlem TüreciBiopharmaceutical New Technologies (BioNTech) Corporation, Mainz, Germany.
Astellas Pharma (United States) · USBioNTech (Germany) · DEKrankenhaus Nordwest · DEUniversity Medical Center of the Johannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundZolbetuximab plus first-line EOX (epirubicin, oxaliplatin, capecitabine; ZOL/EOX) significantly prolonged progression-free survival and overall survival in the FAST trial vs EOX alone. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma.

methodsPatients were randomized to ZOL/EOX or EOX alone. Patients could receive ≤ 8 EOX cycles and remained on zolbetuximab until disease progression. PROs were collected using the EORTC QLQ-C30 and QLQ-STO22 before drug administration at day 1/cycle 1, day 1/cycle 5, end of EOX treatment, and q12w thereafter until disease progression. Time to deterioration (TTD), defined as the first meaningful worsening from baseline, in the individual QLQ-C30/QLQ-STO22 scores was analyzed. Longitudinal changes in scores from baseline were analyzed using a mixed-effects model for repeated measures (MMRM).

resultsThe per protocol population included 143 (ZOL/EOX: 69; EOX: 74) patients. Baseline QLQ-C30 and STO22 scores were comparable between arms and denoted intermediate-to-high quality of life (QoL), intermediate-to-low global health status (GHS) and low symptom burden. Descriptive analyses showed no differences between arms until end of EOX but maintenance therapy with zolbetuximab was associated with better QoL and less symptom burden thereafter. TTD for most scores favored ZOL/EOX over EOX and reached statistical significance for GHS (p = 0.008). MMRM results support TTD findings; no statistically significant differences were observed between arms in any score except for nausea and vomiting (p = 0.0181 favoring EOX).

conclusionsZOL/EOX allowed patients to maintain good QoL and low symptom burden for longer than EOX alone.

Indexed as

AdenocarcinomaAntibodies, MonoclonalAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineClaudinsEpirubicinEsophageal NeoplasmsFemaleHumansMaleMiddle AgedNeoplasm MetastasisOxaliplatinPatient Reported Outcome MeasuresProgression-Free SurvivalAntibodies, MonoclonalAntineoplastic AgentsCapecitabineClaudinsCLDN18 protein, humanEpirubicinOxaliplatinzolbetuximabAntibodiesBiomarkersMonoclonalPatient-reported outcomesQuality of lifeStomach cancer

Identifiers

PMID33755863
PMCPMC8064997
OpenAlexW3136774649

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.