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[Maximum tolerated dose of tegafur in rats]
Gan to Kagaku Ryoho. Cancer & Chemotherapy
|October 1, 1984
Summary
The maximum tolerated dose of Tegafur in male rats was determined to be 90 mg/kg/day. Higher doses led to significant mortality due to severe pneumonia and other toxic effects.
Area of Science:
- Pharmacology
- Toxicology
- Animal Studies
Context:
- Tegafur is an antineoplastic agent.
- Determining the maximum tolerated dose (MTD) is crucial for drug safety assessment.
- This study investigates Tegafur's toxicity in a preclinical model.
Purpose:
- To establish the Maximum Tolerated Dose (MTD) of Tegafur via oral administration in male Donryu rats.
- To evaluate the toxicological profile of Tegafur at various dose levels.
- To identify potential target organs for Tegafur-induced toxicity.
Summary:
- Tegafur was administered orally to male Donryu rats at doses of 90, 120, and 150 mg/kg/day for 24 weeks.
- Mortality rates were high (60%) at 120 and 150 mg/kg/day, primarily due to severe pneumonia.
- The 90 mg/kg/day group showed suppressed body weight gain and minor histological changes (lung inflammation, liver congestion/necrosis, bone marrow degeneration), leading to the MTD determination.
Impact:
- Establishes a critical dose threshold for Tegafur safety in preclinical settings.
- Provides essential data for future clinical trial design and dose selection.
- Highlights potential risks, particularly pulmonary toxicity, associated with Tegafur administration.