Key result
BR96-Doxorubicin was well tolerated at an optimal phase II dose of 700 mg/m2 every 3 weeks, with dose-limiting gastrointestinal toxicity at 875 mg/m2, and yielded objective responses in 2 patients.
Why the study?
What is the toxicity, maximum-tolerated dose, pharmacokinetics, and immunogenicity of BR96-Doxorubicin in patients with Lewis Y-expressing epithelial tumors?
Population
66 patients with Lewis Y-expressing epithelial tumors (predominantly metastatic colon and breast cancer)
Design
Other
Authors
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Supports phase II evaluation of BR96-Doxorubicin in Lewis Y-positive tumors; leaves open efficacy and role pending larger trials.
What is the toxicity, maximum-tolerated dose, pharmacokinetics, and immunogenicity of BR96-Doxorubicin in patients with Lewis Y-expressing epithelial tumors?
BR96-Doxorubicin is well tolerated at 700 mg/m2 every 3 weeks with appropriate prophylaxis, providing a strategy to deliver doxorubicin to Lewis Y-expressing tumors.
Saleh et al. (2000) studied Lewis Y-expressing epithelial tumors (n=66). BR96-Doxorubicin was evaluated on toxicity, maximum-tolerated dose, pharmacokinetics, and immunogenicity. BR96-Doxorubicin was well tolerated at an optimal phase II dose of 700 mg/m2 every 3 weeks, with dose-limiting gastrointestinal toxicity at 875 mg/m2, and yielded objective responses in 2 patients.
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