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Irinotecan plus temozolomide for pediatric relapsed or refractory solid tumors: a retrospective cohort study
Jianming Fang1, Yingli Zhang1, Qi Liu1
1Department of Hematology and Solid Tumors, Beijing Jingdu Children's Hospital, Beijing, China.
Translational Pediatrics
|July 11, 2026
Summary
The irinotecan and temozolomide (IT) regimen showed clinical activity in treating relapsed or refractory pediatric solid tumors. This combination therapy was tolerable, with manageable side effects in Chinese children.
Area of Science:
- Pediatric Oncology
- Medical Oncology
- Pharmacology
Background:
- Relapsed or refractory pediatric solid tumors have a poor prognosis with limited salvage therapy options.
- Real-world data on irinotecan and temozolomide (IT) combination therapy in Chinese pediatric populations are lacking.
- This study addresses the need for evaluating IT efficacy and safety in this specific demographic.
Purpose of the Study:
- To evaluate the efficacy and safety of the irinotecan and temozolomide (IT) regimen.
- To assess treatment response, survival outcomes, and adverse events in pediatric patients with recurrent or refractory solid tumors.
- To provide real-world data for Chinese pediatric oncology.
Main Methods:
- A single-center retrospective cohort study of 86 pediatric patients.
- Patients received irinotecan (50 mg/m2/day, days 1-5) and temozolomide (100-150 mg/m2/day, days 1-5) in 21-day cycles.
- Tumor response assessed by RECIST 1.1; primary endpoints were objective response rate (ORR) and progression-free survival (PFS).
Main Results:
- The objective response rate (ORR) was 23.3% and disease control rate (DCR) was 52.4%.
- For neuroblastoma (n=52), ORR was 31.0% and DCR was 67.3%.
- Median progression-free survival (PFS) was 5.5 months, and median overall survival (OS) was 9.8 months. Grade III-IV neutropenia and thrombocytopenia were common adverse events.
Conclusions:
- The irinotecan and temozolomide (IT) regimen demonstrated clinical activity in relapsed/refractory pediatric solid tumors.
- The treatment was tolerable in this cohort, with manageable adverse events.
- Findings are hypothesis-generating and warrant prospective controlled studies for confirmation.
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