Abstract
In preventing invasive fungal disease (IFD) in patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS), clinical trials demonstrated efficacy of posaconazole over fluconazole and itraconazole. However, effectiveness of posaconazole has not been investigated in the United States in real-world setting outside the environment of controlled clinical trial. We performed a single-center, retrospective cohort study of 130 evaluable patients ≥18 years of age admitted to Duke University Hospital between 2004 and 2010 who received either posaconazole or fluconazole as prophylaxis during first induction or first reinduction chemotherapy for AML or MDS. The primary endpoint was possible, probable, or definite breakthrough IFD. Baseline characteristics were well balanced between groups, except that posaconazole recipients received reinduction chemotherapy and cytarabine more frequently. IFD occurred in 17/65 (27.0%) in the fluconazole group and in 6/65 (9.2%) in the posaconazole group (P = 0.012). Definite/probable IFDs occurred in 7 (10.8%) and 0 patients (0%), respectively (P = 0.0013). In multivariate analysis, fluconazole prophylaxis and duration of neutropenia were predictors of IFD. Mortality was similar between groups. This study demonstrates superior effectiveness of posaconazole over fluconazole as prophylaxis of IFD in AML and MDS patients. Such superiority did not translate to reductions in 100-day all-cause mortality.
Highlights
Invasive fungal disease (IFD) is an important cause of morbidity and mortality in leukemic patients [1, 2]
A randomized controlled clinical trial of antifungal prophylaxis with oral posaconazole reported overall mortality was reduced in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) undergoing induction chemotherapy relative to standard azole prophylaxis [5]
A total of 1382 patients were identified by query of an electronic medical record database. 1252 patients were excluded based on study inclusion/exclusion criteria; 130 patients were included
Summary
Invasive fungal disease (IFD) is an important cause of morbidity and mortality in leukemic patients [1, 2]. Despite the advances of new antifungal agents and diagnostic tools, mortality from IFDs in these patients remains high [3]. Strategies to address this problem include prophylactic, preemptive, and empirical administration of systemic antifungals [1, 4]. In a second clinical trial in allogeneic stem cell transplant recipients with graft-versus-host disease (GVHD), posaconazole was as effective as fluconazole at preventing all IFDs and superior in preventing proven/probable invasive aspergillosis [6]. Primary prophylaxis with posaconazole has been recommended in select international guidelines for patients with malignancy at high-risk of IFDs [7,8,9]
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