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Article 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 and incrementally escalated by 5 mg/m 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) experienced dose-limiting toxicities. Ultimately, the MTD of PLD was established as 50 mg/m (single cycle) in combination of IFO (3 g/m/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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC12338094 | PMC |
| http://dx.doi.org/10.2147/DDDT.S529231 | DOI Listing |
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