Evidence map›Paper›PMID 42421963›Full record

Observational studyFrontiers in immunology2026

Hepatic safety of sintilimab versus pembrolizumab in advanced non-small cell lung cancer: a retrospective observational cohort study.

Pan Ma, Yumeng Zhou, Xin Zhang, Quanfeng Zhao, Yu Peng, Hailong Jiang, Linli Xie, Yan Liao

Abstract readObservational StudyComparative Study
In one paragraph

Observational study in Frontiers in immunology, 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.

Pan Ma *Department of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, China.
Yumeng Zhou *Department of Disease Prevention and Control, Daping Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University, Chongqing, China.
Xin ZhangDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, China.
Quanfeng ZhaoDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, China.
Yu PengDepartment of Oncology, The First Affiliated Hospital of Army Medical University, Chongqing, China.
Hailong JiangDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, China.
Linli XieDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, China.
Yan LiaoDepartment of Pharmacy, The First Affiliated Hospital of Army Medical University, Chongqing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Sintilimab and Pembrolizumab are widely used in non-small cell lung cancer (NSCLC), yet direct comparisons of their safety profiles, particularly hepatotoxicity, are lacking. Given the differences in binding affinities and the complexity of patients in real-world settings, this study aims to provide a head-to-head comparison of their hepatic safety to guide clinical decision-making. Methods: We conducted a retrospective observational cohort study to evaluate potential differences in liver function damage between Sintilimab and Pembrolizumab, administered as monotherapy or combination with chemotherapy, in patients with advanced NSCLC. Patients treated with Sintilimab or Pembrolizumab at Southwest Hospital were included. Propensity score matching (PSM) was performed using height and treatment regimen as covariates to balance between-group differences. Cox proportional hazards models and Kaplan-Meier curves were used to assess differences in hepatotoxicity. Benjamini-Hochberg correction was applied for multiple comparisons across liver function indicators. Results: A total of 222 patients with advanced NSCLC treated with Sintilimab or Pembrolizumab were included. The combination chemotherapy regimens did not differ significantly between the two groups. The overall incidence of hepatic-related adverse events (AEs) was 17.1% in the Sintilimab group and 18.1% in the Pembrolizumab group. No significant differences were observed in AEs related to liver function indicators, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and total bilirubin (TBIL). Kaplan-Meier analysis revealed similar risks of hepatotoxicity between the two treatment regimens. No Grade 3 or higher hepatotoxicity events were observed in either group. Conclusions: In this retrospective observational cohort of Chinese patients with advanced NSCLC, Sintilimab and Pembrolizumab demonstrated comparable hepatic safety profiles, with no significant difference in the incidence, timing, or severity of hepatotoxicity. These findings suggest that Sintilimab may represent a clinically acceptable PD-1 inhibitor option without evidence of increased hepatic risk compared with Pembrolizumab in this setting. Further prospective, multi-center studies with larger and multi-ethnic cohorts are warranted to validate these findings.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungChemical and Drug Induced Liver InjuryLung NeoplasmsAgedFemaleHumansMaleMiddle AgedRetrospective StudiesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabhepatotoxicityimmune checkpoint inhibitornon-small cell lung cancerpembrolizumabreal-worldsintilimab

Identifiers

PMID42421963
PMCPMC13341631

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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.