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Genetic toxicity studies Docetaxel was evaluated for potential genetic toxicity in a battery of standard tests. All in vitro tests were performed in the presence and the absence of an appropriate metabolic activation system. Docetaxel has no mutagenic activity in five strains of Salmonella σρhimurium or in the WP2 uvrA strain of Escherichia coli. No evidence of mutagenic activity was found in the hypoxanthine-guanine-phosphoribosyltransferase (HGPRT) test in Chinese hamster ovary cells (CHO-Kl). In the in vitro micronucleus test in CHO-Kl cells, docetaxel induced, in the presence and absence of metabolic activation, a dose-dependent increase in the number of micronucleated cells at concentrations of 0.3μg/ ml and above. In an in viitro chromosomal aherration test using CHO-K1 cells. docetaxel had no clastogenic effect. hut induced pronounced polyploidy at concentrations of 0.5μg/ ml and ahove without metabolic activation‘ and at 0.1μ g/ ml and above in presence of metabolic activation. In the in vivo micronucleus test , mice were treated with two doses ranging from 0.195 to 7.2 mg/ kg within a 24 h interval; in this test docetaxel induced an increase in the number of polychromatic micronucleated erythrocytes in the bone marrow at a total dose of 1. 54 mg/kg and above. The results of genotoxicity tests indicated that docetaxel was non-mutagenic and non-c1astogenic , but significantly increased the incidence of micronucleated, aneuploid and polyploid cells in vitro and in vivo. This effect is consistent with the pharmacological activity of the drug on microtubules and has been reported for paclitaxel, the prototype taxoid, and for spindle poisons such as vincristine. |
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