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Reproductive toxicity studies The reproductive toxicity of docetaxel was investigated in CD rats and NZW rahhits. In a fertility study. male rats were treated for 70 days prior to and through mating with daily doses of up to 1.8 mg/m2 docetaxel. while females received daily doses of up to 1.35mg m2 from 15 days prior to mating through day 7 of gestation At the intermediate (0 .9 mg m2 ) and (1.35 or1.8 mg/m2 ) high dose levels. docetaxel produced maternal and paternal toxicit associated with a reduction in mean body weight (males and females). testicular weight, and a reduction in fertility param eters , such as the number of corpora lutea and implantations, litter size and number of live fetuses associated with increased resorptions. Therefore. the drug was considered to be embryotoxic at daily doses of 0.9 mg/m2 and above. However, no external fetal malformations were observed at any dose level. The no-effect level in this study was 0.3 mg/m2/ day. Pregnant rats and rabbits were treated with daily doses of up to 1.8 mg/m2 (rat) or 2.4 mg/m2 (rabbit) during the organogenesis phase of gestation. In rats , 1.8 mg/m2/day produced an increase in post-implantation loss, reduced fetal weight and a delay in fetal ossification. No treatment-related external, skeletal or visceral malformations were observed and post-natal development was not affected in any group. ln rabbits, 2.4 mg/m2/ day was lethal to most of the dams. A dose of 1.2 mg/m2 produced marked maternal toxicity, an increased incidence in abortions and reduced fetal weight associated with a delay in fetal ossification. No compound-related external, skeletal or visceral malformations were observed in this study. No adverse embryo-fetal effects were noted following maternal exposure to 0.18 mg/m2 (rat) or 0.36 mg/m2 (rabbit). In conclusion, docetaxel was non-teratogenic, but was embryo- and fetotoxic. The increased abor tion rate in rabbits treated with daily doses of 1.2 mg/m2 and above is a common response of rabbits to maternal toxicity83 In addition, the results of a fertility study and the adverse effects observed in the testes of rats and mice indicate that docetaxel, like paclitaxel or other antimitotic drugs , has the potential to affect fertility。 |
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