Invasive fungal infections are a common cause of morbidity and mortality in allogeneic bone marrow transplant (BMT) patients both before and after engraftment. In this multicenter trial, allogeneic BMT patients were randomized to receive long-term antifungal prophylaxis with either itraconazole (ITRA) (200 mg IV q12hrs for 2 days followed by 200mg IV q24hrs. or 200 mg oral solution q12hrs.) or fluconazole (FLU) (400 mg IV or orally q24hrs.) from day 1 until day 100 after BMT. Each study drug was given IV for the first 14 days followed by oral therapy. Patients unable to take oral therapy returned to IV study drug. 71 patients received ITRA; 67 patients received FLU. Proven invasive fungal infections occurred in 6/71 (9%) ITRA patients and 17/67 (25%) FLU patients within 180 days after BMT (p=0.01). Proven superficial fungal infections occurred in 3/71 (4%) ITRA patients and 2/67 (3%) FLU patients. In a multivariable analysis using factors previously known to affect the risk of invasive fungal infection after BMT, prophylaxis with ITRA was still associated with a lower risk for invasive fungal infection (p=0.02) caused by either yeasts or molds. Death from fungal infection occurred in 6/71 (9%) ITRA patients and 12/67 (18%) FLU patients (p=0.13). Both ITRA and FLU were generally well-tolerated. Nausea was more frequent with ITRA. There was no appreciable hepatotoxicity with either ITRA or FLU. These results suggest that IV/oral ITRA may be more effective than IV/oral FLU for long-term prophylaxis of early and late invasive fungal infections after allogeneic BMT.
Full conference title:
43rd American Society of Hematology (ASH) Annual Meeting
- ASH 43rd (2001)