Evidence map›Paper›PMID 40547017›Full record

ArticleFrontiers in immunology2025

Safety and efficacy of sintilimab versus pembrolizumab in the treatment of advanced or recurrent pediatric malignancies: a real-world study in China.

Lei Mao, Mengzhen Li, Linnan Wu, Juan Wang, Yi Que, Feifei Sun, Junting Huang, Suying Lu, Zijun Zhen, Jia Zhu and 2 more

Abstract readComparative Study
In one paragraph

Article in Frontiers in immunology, 2025. 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
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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

12 authors.

Lei Mao *Department of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Mengzhen Li *Department of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Linnan Wu *Department of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Juan WangDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Yi QueDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Feifei SunDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Junting HuangDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Suying LuDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Zijun ZhenDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Jia ZhuDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Mengjia SongDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Yizhuo ZhangDepartment of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Programmed death receptor 1 (PD-1) inhibitors have shown durable response and mild adverse events in adult malignancies. However, study on PD-1 inhibitors in pediatric patients remains limited, and a direct comparison of distinct PD-1 inhibitors in pediatric tumors is lacking. Methods: We conducted a retrospective analysis of 75 pediatric patients with advanced or recurrent malignancies treated with either Sintilimab-based (n=53) or Pembrolizumab-based (n=22) regimens. The primary endpoints included treatment-related adverse events (TRAEs) and objective response rate (ORR), and the second endpoints included progression-free survival (PFS) and overall survival (OS). Results: The incidence of hypothyroidism, hyperthyroidism, pneumonia, increased ALT/AST, gastroenteritis, and rash following immune checkpoint inhibitor therapy showed no significant differences between the Sintilimab group and the Pembrolizumab group (all P>0.05). Cardiovascular Adverse Events (CVAEs) occurred in 26.0% (15/53) of Sintilimab-treated patients versus 40.0% (8/20) of Pembrolizumab-treated patients (P=0.26). In the lymphoma cohort (n=13), 88.9% of Sintilimab-treated patients and 75.0% of Pembrolizumab-treated patients achieved complete response (CR) or partial response (PR) (P=0.54). The median PFS and OS were not reached in either group. In the non-lymphoma cohort (n=53), 40.5% of Sintilimab-treated patients and 25.0% of Pembrolizumab-treated patients achieved CR or PR (P=0.18). Among 39 patients who had received ≤ 2 prior treatment lines, the PFS and OS showed no significant differences between the Sintilimab (n=30) and Pembrolizumab (n=9) groups (P=0.28 and P=0.09, respectively). Similarly, among 14 patients who had received>2 prior treatment lines, no significant differences in PFS and OS were observed between the Sintilimab(n=7) and Pembrolizumab(n=7) groups (P=0.33 and P=0.15, respectively). Conclusions: Sintilimab demonstrated favorable tolerability and efficacy in pediatric patients with malignancies, with a safety and efficacy profile comparable to Pembrolizumab. For pediatric patients with advanced or recurrent malignancies receiving immune checkpoint inhibitor therapy, long-term monitoring of thyroid and cardiac function is recommended.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorsNeoplasm Recurrence, LocalNeoplasmsAdolescentChildChild, PreschoolChinaFemaleHumansInfantMaleRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorspembrolizumabsintilimabefficacyPD-1 inhibitorspediatric malignanciespembrolizumabsafetysintilimab

Identifiers

PMID40547017
PMCPMC12179053

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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.