Key result
DSPC PEGylated liposomal doxorubicin establishes a 45 mg/m2 recommended dose limited by severe stomatitis.
Why the study?
What are the pharmacokinetic properties, toxicity profile, and maximal tolerated dose of PEGylated liposomal doxorubicin with DSPC in patients with solid tumors?
Population
26 patients with solid tumors
Design
Other
Authors
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Supports Phase II dosing at 45 mg/m2 q3w; leaves open efficacy and safety confirmation in randomized trials.
What are the pharmacokinetic properties, toxicity profile, and maximal tolerated dose of PEGylated liposomal doxorubicin with DSPC in patients with solid tumors?
DSPC PLD exhibits second-generation liposomal pharmacokinetics with dose-limiting stomatitis at 50 mg/m2, establishing 45 mg/m2 every 3 weeks as the recommended Phase II dose.
Hong et al. (2001) studied Solid tumors (n=26). PEGylated liposomal doxorubicin (DSPC PLD) was evaluated on Pharmacokinetic properties, toxicity profile, and maximal tolerated dose. DSPC PEGylated liposomal doxorubicin showed dose-independent pharmacokinetics and a recommended Phase II dose of 45 mg/m2 every 3 weeks, with severe stomatitis becoming dose-limiting at 50 mg/m2.
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