Phase I Trial of Pegylated Liposomal Doxorubicin Combined with Ifosfamide for Advanced Soft Tissue Sarcoma
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Introduction: This study aimed to determine the maximum tolerated dose (MTD) of pegylated liposomal doxorubicin (PLD) combined with both ifosfamide (IFO) and supported by human granulocyte colony-stimulating factor (rhG-CSF) for treating advanced soft tissue sarcoma (STS). Methods: Twenty-three patients were enrolled in this trial with 3+3 dose-escalation from January 2020 to September 2022. PLD was initiated at 30 mg/m 2 and incrementally escalated by 5 mg/m 2 per step. MTD was the primary endpoint, and the safety profile served as the secondary endpoint. Results: Two patients treated with PLD (55 mg/m 2 ) experienced dose-limiting toxicities. Ultimately, the MTD of PLD was established as 50 mg/m 2 (single cycle) in combination of IFO (3 g/m 2 /day for days 1– 3) and supported by rhG-CSF. Across all dose levels, common grade 3/4 adverse events included leukopenia (86.96%), neutropenia (82.61%), and lymphopenia (56.52%). Twelve of the 23 patients voluntarily chose to continue treatment with this regimen. The overall response rate was 33.33% (95% confidence interval: 9.92– 65.11), and the disease control rate was 83.33% (95% confidence interval: 51.59– 97.91). Conclusion: This study successfully determined the MTD of PLD in combination with IFO and rhG-CSF for advanced STS, offering a potentially valuable treatment option with a tolerable safety profile. Keywords: soft tissue sarcomas, pegylated liposomal doxorubicin, ifosfamide, dose-escalation, safety
DOI: 10.2147/dddt.s529231
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,836
OpenAlex ID: W4413021756