Efficacy and Safety of Fluconazole Prophylaxis for Fungal Infections after Marrow Transplantation--A Prospective, Randomized, Double-Blind Study

Abstract

A randomized, double-blind, placebo-controlled trial assessed the efficacy and toxicity of 400 mg/day fluconazole in preventing fungal infections during the first 75 days after marrow transplantation. During prophylaxis, systemic fungal infections occurred in 10 (7%) of 152 fluconazole-treated patients compared with 26 (18%) of 148 placebo-treated patients (P = .004). There were no Candida albicans infections in fluconazole recipients compared with 18 in placebo recipients (P < .001) and no significant increase in Candida infections other than C. albicans. Fluconazole also significantly reduced the incidence of superficial fungal infections (P < .001), fungal colonization (P = .037), and empiric amphotericin B use (P = .005). The probability of survival was improved in fluconazole recipients, in whom 31 deaths occurred up to day 110 after transplantation compared with 52 deaths in placebo recipients (P = .004). No clinically significant toxicity was detected with fluconazole use. Prophylactic fluconazole was safe and significantly reduced systemic fungal infections with other benefits, including improved survival at day 110 after marrow transplantation.

Practical modalities for prevention of fungal infections in cancer patients

“…In a prospective, double-blind, placebo-controlled, multicenter study of patients undergoing bone marrow transplantation (7), prophylaxis with fluconazole at a dosage of 400 mg once dai ly was effective in preventing superficial and dis seminated candidiasis and in lowering overall mortality. These results were confirmed in a trial by Slavin et al (8 ). The same results were found in a retrospective study performed at the Detroit Medical Center (9) in which a lower dosage (100-200 mg daily) was given.…”

Efficacy and safety of micafungin for prophylaxis of invasive fungal infections in patients undergoing haplo-identical hematopoietic SCT

“…Moreover, the recent emergence of resistance to fluconazole has highlighted the need for more effective and alternative drugs. [24][25][26][27][28] We therefore hypothesized that micafungin would be an alternative to fluconazole as antifungal prophylaxis, with broader-spectrum activity against invasive aspergillosis during neutropenia. We conducted this observational study to evaluate the safety and efficacy of micafungin for prophylaxis of IFI in a high-risk homogeneous population of patients undergoing haplo-SCT, who received a median of seven lines of chemotherapy.…”

Clinical efficacy and safety of primary antifungal prophylaxis with posaconazole vs itraconazole in allogeneic blood and marrow transplantation

“…[6][7][8] Fluconazole has been used for antifungal prophylaxis for more than a decade, improving the outcome of allo-BMT recipients through an effective reduction of the incidence of invasive Candida infections. [9][10][11] For nearly as long, and in the context of a changing epidemiology, the challenge remained to identify antifungal agents with a good safety profile that could successfully prevent mould infections, in particular invasive pulmonary aspergillosis (IPA), and reduce fungal-related mortality. 2,3,[12][13][14][15][16] Posaconazole is a new-generation triazole agent with a favourable toxicity profile and an extended spectrum of antifungal activity that includes species of Candida, Aspergillus, Zygomycetes and Fusarium.…”