Evidence map›Paper›PMID 39146670›Full record

ArticleESMO open2024

Health-related quality of life in patients with CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: results from the SPOTLIGHT and GLOW clinical trials.

F Lordick, E Van Cutsem, K Shitara, R-H Xu, J A Ajani, M A Shah, M Oh, A Ganguli, L Chang, S Rhoten and 6 more

2 registry-linked trialsAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing 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.

NCT03504397 phase3active not recruitingnot on this map

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2018 to 2026Enrolled565ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaArmszolbetuximab, placebo, oxaliplatin, folinic acid, fluorouracil
NCT03653507 phase3active not recruitingnot on this map

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2018 to 2026Enrolled507ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaArmszolbetuximab, oxaliplatin, capecitabine, placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. 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
  3. Review
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  5. Long-term quality of life, financial toxicity, and decision regret following therapeutic and prophylactic gastrectomy for cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Article
  6. Review
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  9. Article
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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

16 authors.

F LordickDepartment of Medicine and University Cancer Center Leipzig, University of Leipzig Medical Center, Leipzig, Germany.
E Van CutsemDigestive Oncology, University Hospitals Gasthuisberg, Leuven, and KULeuven, Leuven, Belgium.
K ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa City, Chiba, Japan.
R-H XuDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Sun Yat-sen University, Guangzhou; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China.
J A AjaniThe University of Texas, MD Anderson Cancer Center, Houston.
M A ShahWeill Cornell Medical College, New York City.
M OhAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
A GanguliAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
L ChangAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
S RhotenIQVIA, San Francisco, USA.
P BhattacharyaAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
M MatsangouAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
J W ParkAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
R PophaleAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
R RanganathAstellas Pharma Global Development, Inc., Northbrook. Electronic address: https://twitter.com/AstellasUS.
Y-K KangDepartment of Oncology, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea. Electronic address: ykkang@amc.seoul.kr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFirst-line zolbetuximab plus chemotherapy (SPOTLIGHT, mFOLFOX6; GLOW, CAPOX) significantly improved progression-free survival (PFS) and overall survival (OS) versus placebo plus chemotherapy in patients with human epidermal growth factor receptor 2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors were claudin 18 isoform 2-positive in the phase III SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) studies. We present patient-reported outcomes (PROs) from these studies. MATERIALS AND

methodsHealth-related quality of life (HRQoL) was measured in the full analysis sets using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients Core Questionnaire (QLQ-C30) and Oesophago-Gastric Module (QLQ-OG25), Global Pain, and 5-level EQ-5D (EQ-5D-5L) questionnaires. Analyses focused on key PRO domains: global health status (GHS)/QoL, physical functioning, abdominal pain and discomfort, and nausea/vomiting. Least squares mean (LSM) changes from baseline and time to first definitive deterioration (TTDD) were evaluated combined across SPOTLIGHT and GLOW and for individual studies. Time to confirmed deterioration (TTCD) was evaluated independently for SPOTLIGHT and GLOW.

resultsThe combined analysis set included 1072 patients (zolbetuximab plus chemotherapy, 537; placebo plus chemotherapy, 535). Compliance rates were similar between treatment arms. Similar trends were observed in the zolbetuximab versus placebo arms for LSM changes from baseline in key PRO domains, with no clinically meaningful deterioration. Nausea/vomiting worsened during the first few zolbetuximab cycles but later returned to baseline levels. Overall TTCD and TTDD results were similar between arms in both studies.

conclusionsPatients in SPOTLIGHT and GLOW maintained measured HRQoL relative to baseline when treated with first-line zolbetuximab added to chemotherapy. Zolbetuximab plus chemotherapy improved PFS and OS without negatively affecting HRQoL in key PRO domains compared with placebo plus chemotherapy.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsEsophagogastric JunctionQuality of LifeStomach NeoplasmsAdultAgedClaudinsClinical Trials, Phase III as TopicEsophageal NeoplasmsFemaleFluorouracilHumansLeucovorinMaleMiddle AgedClaudinsCLDN18 protein, humanFluorouracilLeucovorinOrganoplatinum CompoundsCLDN18.2gastric adenocarcinomagastroesophageal junction adenocarcinomapatient-reported outcomesquality of lifezolbetuximab

Identifiers

PMID39146670
PMCPMC11374961

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.