Evidence map›Paper›PMID 41741112›Full record

ArticleESMO open2026

Impact and effective management of nausea/vomiting on patients treated with zolbetuximab + chemotherapy: insights from the phase III SPOTLIGHT and GLOW studies.

K Shitara, E Smyth, F Lordick, R Pophale, C Matney, M Matsangou, G Gourgioti, M Oh, R Ranganath, S J Klempner

2 registry-linked trialsAbstract read
In one paragraph

Article in ESMO open, 2026. 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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

7 citing papers in PubMed.

  1. Trial
  2. Importance of Inclusion of Representative Populations in Pivotal Clinical Trials: Zolbetuximab as an Example.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
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

10 authors.

K ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. Electronic address: kshitara@east.ncc.go.jp.
E SmythNIHR Oxford Biomedical Research Centre, Oxford, UK.
F LordickDepartment of Oncology, Gastroenterology, Hepatology, and Pulmonology, Comprehensive Cancer Center Central Germany (CCCG), University of Leipzig Medical Center, Leipzig, Germany.
R PophaleAstellas Pharma Global Development, Inc., Northbrook, USA.
C MatneyAstellas Pharma Global Development, Inc., Northbrook, USA.
M MatsangouAstellas Pharma Global Development, Inc., Northbrook, USA.
G GourgiotiAstellas Pharma Europe Ltd, Addlestone, UK.
M OhAstellas Pharma Global Development, Inc., Northbrook, USA.
R RanganathAstellas Pharma Global Development, Inc., Northbrook, USA.
S J KlempnerDepartment of Medicine, Division of Hematology-Oncology, Massachusetts General Cancer Center, Boston, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase III SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials, nausea and/or vomiting were the most common adverse events in patients receiving zolbetuximab plus chemotherapy. We further characterize the adverse effects of nausea/vomiting on treatment adherence and efficacy, and evaluate strategies for managing nausea/vomiting through the SPOTLIGHT and GLOW combined analysis. MATERIALS AND

methodsAd hoc exploratory analyses included treatment discontinuations, antiemetic use, and progression-free survival (PFS) and overall survival (OS) after censoring patients with inadequate dose exposure (<75% relative exposure intensity) or early discontinuation (within 63 days) of zolbetuximab or placebo initiation.

resultsThis combined analysis included 1072 patients. Nausea and/or vomiting (nausea/vomiting) were most common on the first zolbetuximab infusion day [nausea: 46.5% (246/529); vomiting: 41.0% (217/529)]; on the second infusion day, nausea dropped to 23.2% (97/418) and vomiting dropped to 24.4% (102/418). Nausea/vomiting continued to decline on subsequent infusion days. More patients on zolbetuximab versus placebo had nausea/vomiting leading to inadequate dose exposure or early discontinuation [9.9% (53/537) versus 0.6% (3/535)]. More white than Asian patients had nausea/vomiting leading to inadequate dose exposure or early discontinuation with zolbetuximab [15.4% (36/234) versus 4.7% (12/254)] and placebo [0.9% (2/224) versus 0.4% (1/255)]. Before censoring, median PFS (mPFS) (hazard ratio) for zolbetuximab versus placebo was 9.2 versus 8.2 months (0.71), and median OS (mOS) was 16.4 versus 13.7 months (0.77). After censoring, mPFS was 10.4 versus 8.2 months (0.65), and mOS was 17.9 versus 13.7 months (0.69). On the first zolbetuximab infusion day, patients without vomiting had higher utilization of three-drug prophylactic regimens than those with vomiting [75.3% (73/97) versus 24.7% (24/97)]. In patients receiving steroids, including as antiemetic prophylaxis, mPFS was 10.5 months with zolbetuximab versus 8.3 months with placebo (0.66), and mOS was 18.4 versus 13.8 months (0.71).

conclusionOptimal antiemetic prophylaxis, with >3 drug classes including steroids, for zolbetuximab-associated nausea/vomiting is important for treatment adherence and maximal clinical benefits.

Indexed as

antiemeticgastric cancernauseavomitingzolbetuximab

Identifiers

PMID41741112
PMCPMC12947639

What OpenQuestion holds

Textmetadata
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.