Efficacy and safety of intravenous voriconazole and intravenous itraconazole for antifungal prophylaxis in patients with acute myelogenous leukemia or high-risk myelodysplastic syndrome

Purpose

To compare the efficacy and safety of voriconazole with itraconazole as prophylaxis in leukemia patients.

Methods

Open-label, randomized study. Patients with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing induction chemotherapy or first salvage were eligible. Patients received voriconazole (400?mg intravenous (IV) every 12?h for two doses, followed by 300?mg BID) or itraconazole (200?mg IV twice daily for 2?days, followed by 200?mg IV daily).

Results

A total of 127 patients were enrolled. Four were excluded because they did not receive study drug (n?=?3) or received two antifungal agents during the first week on study (n?=?1), leaving 123 patients for analysis. None of the 71 patients receiving voriconazole developed proven or probable invasive fungal infection, compared to two (4%) of the 52 patients receiving itraconazole (P?=?0.17). Drug discontinuation because of adverse events occurred in 15 patients (21%) receiving voriconazole and six (11%) receiving itraconazole (P?=?0.23).

Conclusions

Voriconazole is a good alternative for prophylaxis in patients with leukemia. Elevated baseline bilirubin levels were associated with a higher risk of side effects in patients receiving IV voriconazole or IV itraconazole. Monitoring of liver function and drug levels should be considered for some patients.