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Antifungal prophylaxis during remission induction therapy for acute leukemia fluconazole versus intravenous
G P Bodey1, E J Anaissie, L S Elting
1Department of Medical Specialties, University of Texas M.D. Anderson Cancer Center, Houston 77030.
Background:
Fungal infection is a frequent and often fatal complication in patients undergoing remission induction therapy for acute leukemia. Although candidiasis is the most common infection, mold infections are increasing in frequency. Fluconazole (FLU) is a new antifungal agent that has been used successfully to treat Candida infections and has modest activity against aspergillosis in animal models. Subtherapeutic doses of amphotericin B (AMB) have been considered effective as prophylaxis in these patients. This study was designed to compare the efficacy and toxicity of these agents as antifungal prophylaxis.
Methods:
Adults with acute leukemia undergoing remission induction chemotherapy randomly were assigned to receive antifungal prophylaxis with AMB (0.5 mg/kg three times weekly) or FLU (400 mg daily). Trimethoprim-sulfamethoxazole was administered as an antibacterial prophylaxis. Prophylaxis was continued until the patient achieved complete remission or was treated for 8 weeks without antileukemic response. Prophylaxis was discontinued if the patient experienced a possible or proven fungal infection or a serious toxicity.
Results:
Overall, 58% of the 36 patients assigned to AMB successfully completed prophylaxis compared with 80% of the 41 patients assigned to FLU (< 0.05). Proven, probable, or possible fungal infections occurred in 31% and 17% of the patients, respectively. The risk of discontinuing prophylaxis due to fungal infection or toxicity increased with time in the study and was significantly greater for AMB (P = 0.02).
Conclusions:
At the dose used in this study, AMB was no more effective and was more toxic than FLU for prophylaxis of fungal infections in patients undergoing remission induction chemotherapy for acute leukemia.
Insights
Fluconazole (FLU) demonstrated superior efficacy and safety compared to amphotericin B (AMB) for fungal infection prophylaxis in acute leukemia patients undergoing chemotherapy. FLU allowed more patients to complete prophylaxis with fewer fungal infections and toxicities.
Area of Science:
- Oncology
- Infectious Diseases
- Pharmacology
Background:
- Fungal infections pose a significant mortality risk for acute leukemia patients during remission induction therapy.
- While candidiasis is common, invasive mold infections are increasingly prevalent.
- Newer antifungals like fluconazole (FLU) show promise, and low-dose amphotericin B (AMB) has been explored for prophylaxis.
Purpose of the Study:
- To compare the efficacy and toxicity of fluconazole (FLU) versus amphotericin B (AMB) for antifungal prophylaxis.
- To evaluate outcomes in adult acute leukemia patients receiving remission induction chemotherapy.
Main Methods:
- Adult acute leukemia patients were randomized to receive either AMB (0.5 mg/kg thrice weekly) or FLU (400 mg daily) for prophylaxis.
- Prophylaxis continued until complete remission or 8 weeks; discontinuation occurred for fungal infection or toxicity.
- Antibacterial prophylaxis with trimethoprim-sulfamethoxazole was administered concurrently.
Main Results:
- Higher completion rates for prophylaxis were observed with FLU (80%) compared to AMB (58%).
- Fungal infections occurred in 31% of AMB patients versus 17% of FLU patients.
- The risk of discontinuing prophylaxis due to infection or toxicity was significantly higher with AMB.
Conclusions:
- At the studied doses, AMB was less effective and more toxic than FLU for fungal prophylaxis in this patient group.
- FLU appears to be a more suitable option for preventing fungal infections during acute leukemia induction chemotherapy.