ORIGINAL RESEARCH article
Front. Oncol.
Sec. Pediatric Oncology
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1518987
This article is part of the Research TopicThe Tumor Immune Microenvironment in Pediatric CancersView all 6 articles
Retrospective analysis of the efficacy and safety of anlotinib plus sintilimab (anti-PD-1) as maintenance therapy in advanced pediatric solid tumors
Provisionally accepted
- 1Henan Provincial Cancer Hospital, Zhengzhou, China
- 2Department of Translational Research & Cellular Therapeutics, Beckman Research Institute, City of Hope, Duarte, California,91010,United States., Duarte, United States
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Background: Advanced solid tumors in children have limited maintenance treatment options.This study assessed the effectiveness and safety of anlotinib in conjunction with sintilimab as maintenance therapy for advanced pediatric solid tumors in real world settings. Methods: This single-institutional, retrospective study was conducted in the Affiliated Cancer Hospital of Zhengzhou University from November 2019 to October 2023. 46 advanced pediatric solid tumor patients who achieved partial response or stable disease following first-line (22/46) or second-line (24/46) chemotherapy subsequently received maintenance therapy with a combination of anlotinib and sintilimab. The primary endpoint is median progression-free survival (mPFS). The second endpoints include median overall survival (mOS), disease control rate (DCR), and safety. Results: After a median follow-up of 21.8 months (95% CI 16.5-27.1), the mPFS was 25.3 months (95% CI 7.0-43.6) in the first-line treatment and 13.3months (95% CI 7.2-19.4) in the second-line treatment. The mOS in the first-line treatment group and the second-line treatment group were 38.2 months (95% CI 22.2-54.1) and 16.5 months (95% CI 12.6-20.4) separately. The DCR was 50.0% (11/22, 95% CI 28-72) and 37.5% (9/24, 95% CI 19-59) in the first-line and second-line respectively. Most of the treatment-related adverse events were grade 1-2. The most common grade 3-4 adverse reaction was anemia (2/46, 4.3%). Conclusion: Our results indicate that maintenance therapy using anlotinib combined with sintilimab could be a safe and effective treatment option for advanced pediatric tumors.
Keywords: advanced pediatric tumors, Anlotinib, Sintilimab, Maintenance therapy, efficacy, Safety
Received: 29 Oct 2024; Accepted: 29 Jul 2025.
Copyright: © 2025 Zhao, Chang, Zhang, He and Wei. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Xudong Wei, Henan Provincial Cancer Hospital, Zhengzhou, China
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