Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Boogaerts, M; Winston, DJ; Bow, EJ; Garber, G; Reboli, AC; Schwarer, AP; Novitzky, N; Boehme, A; Chwetzoff, E; De Beule, K; Itraconazole Neutropenia Study Group (incl. Linkesch, W).
Intravenous and oral itraconazole versus intravenous amphotericin B deoxycholate as empirical antifungal therapy for persistent fever in neutropenic patients with cancer who are receiving broad-spectrum antibacterial therapy. A randomized, controlled trial.
Ann Intern Med. 2001; 135(6): 412-422.
Doi: 10.7326/0003-4819-135-6-200109180-00010
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- Study Group Mitglieder der Med Uni Graz:
- Linkesch Werner
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- Abstract:
- BACKGROUND: Amphotericin B deoxycholate is currently the standard empirical antifungal therapy in neutropenic patients with cancer who have persistent fever that does not respond to antibiotic therapy. However, this treatment often causes infusion-related and metabolic toxicities, which may be dose limiting. OBJECTIVE: To compare the efficacy and safety of itraconazole with those of amphotericin B as empirical antifungal therapy. DESIGN: An open randomized, controlled, multicenter trial, powered for equivalence. SETTING: 60 oncology centers in 10 countries. PATIENTS: 384 neutropenic patients with cancer who had persistent fever that did not respond to antibiotic therapy. INTERVENTION: Intravenous amphotericin B or intravenous itraconazole followed by oral itraconazole solution. MEASUREMENTS: Defervescence, breakthrough fungal infection, drug-related adverse events, and death. RESULTS: For itraconazole and amphotericin B, the median duration of therapy was 8.5 and 7 days and the median time to defervescence was 7 and 6 days, respectively. The intention-to-treat efficacy analysis of data from 360 patients showed response rates of 47% and 38% for itraconazole and amphotericin B, respectively (difference, 9.0 percentage points [95% CI, -0.8 to 19.5 percentage points]). Fewer drug-related adverse events occurred in the itraconazole group than the amphotericin B group (5% vs. 54% of patients; P = 0.001), and the rate of withdrawal because of toxicity was significantly lower with itraconazole (19% vs. 38%; P = 0.001). Significantly more amphotericin B recipients had nephrotoxicity (P < 0.001). Breakthrough fungal infections (5 patients in each group) and mortality rates (19 deaths in the itraconazole group and 25 deaths in the amphotericin B group) were similar. Sixty-five patients switched to oral itraconazole solution after receiving the intravenous formulation for a median of 9 days. CONCLUSIONS: Itraconazole and amphotericin B have at least equivalent efficacy as empirical antifungal therapy in neutropenic patients with cancer. However, itraconazole is associated with significantly less toxicity.
- Find related publications in this database (using NLM MeSH Indexing)
- Administration, Oral -
- Amphotericin B - administration and dosage
- Anti-Bacterial Agents - therapeutic use
- Antifungal Agents - administration and dosage
- Antineoplastic Agents - adverse effects
- Deoxycholic Acid - administration and dosage
- Drug Combinations - administration and dosage
- Fever - etiology
- Infusions, Intravenous - etiology
- Itraconazole - administration and dosage
- Mycoses - complications
- Neoplasms - complications
- Neutropenia - immunology
- Opportunistic Infections - complications
- Risk Factors - complications
- Treatment Failure - complications