Evidence map›Paper›PMID 42885207›Full record

SynthesisCancer medicine2026

Safety Profiles of Immune Checkpoint Inhibitor Strategies in Gastrointestinal Cancers and Their Association With Clinical Outcomes: A Systematic Review and Meta-Analysis.

Jing Lei, Yiyi Yu, Qing Liu, Ningping Zhang, Yi Wang, Yating Yang, Tianshu Liu, Minzhi Lv

Abstract readSystematic ReviewMeta-AnalysisReview
PubMed Publisher
In one paragraph

Synthesis in Cancer medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Jing LeiDepartment of Cancer Screening and Prevention, Zhongshan Hospital, Fudan University, Shanghai, China.
Yiyi YuDepartment of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID https://orcid.org/0000-0002-8444-0235
Qing LiuDepartment of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID https://orcid.org/0000-0001-9534-3329
Ningping ZhangDepartment of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID https://orcid.org/0000-0003-1262-4331
Yi WangDepartment of Cancer Screening and Prevention, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID https://orcid.org/0009-0000-6896-4074
Yating YangDepartment of Biostatistics, School of Public Health, Fudan University, Shanghai, China.
Tianshu LiuDepartment of Cancer Screening and Prevention, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID https://orcid.org/0000-0002-8604-6311
Minzhi LvDepartment of Cancer Screening and Prevention, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID https://orcid.org/0000-0002-7994-2257

Funding

Management Research Project of Shanghai Hospital Association Q2025032Policy Research Project of Shanghai Municipal Administration of Disease Prevention and Control 2025JZ33Shanghai ShenKang Research Physicians Innovation and Transformation Ability Training Project SHDC2022CRT001the Chinese Society of Clinical Oncology (CSCO) Research Fund Y-2019AZQN-1014the Disciplinary Platform Construction Fund of Fudan Zhongshan Hospital Affiliated to Fudan University 2025XKPT18the Disciplinary Platform Development Fund of Fudan Zhongshan Cancer Prevention and Treatment Center 2024KYPT18the National Nature Science Foundation of China 82172925the National Nature Science Foundation of China 82373402
6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) are increasingly used in patients with gastrointestinal cancer (GIC). However, ICI-associated adverse event (AE) profiles in GIC remain poorly characterized, and whether AE incidence is associated with clinical outcomes is unclear.

methodsRandomized controlled trials (RCTs) were identified through February 2025. Primary outcomes included treatment-related AEs (TRAEs) and immune-related AEs (irAEs) (any grade/Grade 3+). Single-arm random-effects meta-analysis pooled AE incidences; risk ratios (RRs) compared toxicity across ICI regimens. Digitized Kaplan-Meier curves reconstructed survival data for pooled analysis and Cox models. Weighted Spearman's tests assessed correlations between AE incidences and median overall survival (OS)/progression-free survival (PFS).

resultsForty RCTs enrolling 10,233 patients investigated ICI monotherapy, dual-ICI therapy, and ICI combination regimens. Pooled any-grade TRAE incidences were 68.0% (monotherapy, 95% CI: 60%-76%, I

conclusionWhile AE incidence is high among GIC patients receiving ICIs, most events are low-grade. Dual-ICI and ICI-based combination therapies carry higher TRAE and irAE risks than monotherapy. At the trial level, higher non-severe irAE incidence correlated with favorable survival outcomes; this exploratory ecological association does not apply to individual patients. SYSTEMATIC REVIEW REGISTRATION: This study was registered on International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY202230144).

Indexed as

Drug-Related Side Effects and Adverse ReactionsGastrointestinal NeoplasmsImmune Checkpoint InhibitorsAntineoplastic Combined Chemotherapy ProtocolsHumansRandomized Controlled Trials as TopicTreatment OutcomeImmune Checkpoint Inhibitorsgastrointestinal cancerimmune checkpoint inhibitorsimmune‐related adverse eventstreatment‐related adverse events

Identifiers

PMID42885207

What OpenQuestion holds

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Registered trials

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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.