Safety and Efficacy of Itraconazole Compared to Amphotericin B as Empirical Antifungal Therapy for Neutropenic Fever in Patients with Haematological Malignancy*
Abstract:
Safety, tolerability and efficacy of itraconazole and amphotericin
B (AMB) were compared for empirical antifungal treatment
of febrile neutropenic cancer patients. Patients and Methods:
In an open, randomised study, 162 patients with at least 72 h of
antimicrobial treatment received either intravenous followed by
oral itraconazole suspension or intravenous AMB for a maximum of
28 days. Permanent discontinuation of study medication due to any
adverse event was the primary safety parameter. Efficacy parameters
included response and success rate for both treatment groups.
Results: Significantly fewer itraconazole patients discontinued treatment
due to any adverse event (22.2 vs. 56.8% AMB; p < 0.0001).
The main reason for discontinuation was a rise in serum creatinine
(1.2% itraconazole vs. 23.5% AMB). Renal toxicity was significantly
higher and more drug-related adverse events occurred in the AMB
group. Intention-to-treat (ITT) analysis showed favourable efficacy
for itraconazole: response and success rate were both significantly
higher than for AMB (61.7 vs. 42% and 70.4 vs. 49.3%, both
p < 0.0001). Treatment failure was markedly reduced in itraconazole
patients (25.9 vs. 43.2%), largely due to the better tolerability.
Conclusions: Itraconazole was tolerated significantly better than
conventional AMB and also showed advantages regarding efficacy.
This study confirms the role of itraconazole as a useful and
safe agent in empirical antifungal therapy of febrile neutropenic
cancer patients.
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.
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