Optimal use of docetaxel (Taxotere®)

Abstract

The safety of docetaxel (Taxotere) has been evaluated in the safety overview population consisting of 1070 patients recruited to phase II trials. These patients received a total of 4989 cycles of therapy (median four cycles per patient). Since docetaxel is known to be metabolized in the liver, hepatic impairment was predicted to be a risk factor for increased toxicity and was studied prospectively, comparing the 42 patients in the overview population with moderate hepatic impairment with the 1028 patients with liver function within normal limits. Hepatic dysfunction was associated with an increase in the percentage of cycles of therapy during which febrile neutropenia occurred and the number of patients suffering documented infection and severe (grade 3/4) stomatitis. The incidence of toxic death was also increased in patients with moderate hepatic impairment. The severity of fluid retention, a cumulative toxicity of docetaxel, was found to be reduced, and its onset delayed, by prophylactic treatment with corticosteroids for 5 days, starting 1 day before docetaxel administration. Treatment with corticosteroids was also recommended to reduce the incidence and severity of hypersensitivity reactions and cutaneous toxicities. The most frequent severe non-haematological toxicity of docetaxel was asthenia. Other non-haematological toxicities were generally mild or moderate.