Intravenous and Oral Itraconazole versus Intravenous and Oral Fluconazole for Long-Term Antifungal Prophylaxis in Allogeneic Hematopoietic Stem-Cell Transplant Recipients: A Multicenter, Randomized Trial

Winston, Drew J.; Maziarz, Richard T.; Chandrasekar, Pranatharthi H.; Lazarus, Hillard M.; Goldman, Mitchell; Blumer, Jeffrey L.; Leitz, G; Territo, Mary

doi:10.7326/0003-4819-138-9-200305060-00006

Cited by 363 publications

(244 citation statements)

References 37 publications

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“…Although the feasibility of persistent protection by FLCZ has been described in one report, the optimal duration of prophylaxis also remains uncertain for patients who are administered immunosuppressants for a long time, especially in cases with non-myeloablative cord blood transplantation [9]. Although several authors have reported that acute GVHD and the administration of PSL were risk factors for invasive aspergillosis, our study did not show such a relationship because of the small number of patients, as Winston et al reported previously [11,14,20]. Although a long neutropenic period is also a risk factor for IFI, the difference between neutropenic periods in the two groups in this study was not significant.…”

Section: Discussioncontrasting

confidence: 52%

“…However, its use was costly because most patients suffered from severe stomatitis and required the intravenous administration of FLCZ instead of oral capsules. Moreover, the rates of treatment success of FLCZ in allogeneic SCT settings are 68 to 81% [7,10,11]. One of the major concerns about the use of FLCZ is its lack of activity against Aspergillus species and some non-albicans Candida species.…”

Section: Discussionmentioning

confidence: 99%

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Administration of micafungin as prophylactic antifungal therapy in patients undergoing allogeneic stem cell transplantation

et al. 2007

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Objective: Invasive fungal infection is one of the major causes of death in neutropenic patients undergoing allogeneic stem cell transplantation (SCT). Although prophylactic antifungal therapy with fluconazole (FLCZ) has become the standard care for these patients, there remains a need for more effective and cost-beneficial alternative drugs.Patients and Methods: We conducted a prospective study to evaluate the usefulness of the administration of micafungin (MCFG) as a prophylactic antifungal therapy for patients undergoing allogeneic SCT. The results were compared with previous data for patients who had received FLCZ.Results: A total of 44 patients who underwent allogeneic SCT were enrolled in the study.Data from 29 patients who received allogeneic SCT using prophylactic FLCZ before this study were used as historical control data. Underlying diseases included acute leukemia (n=16), non-Hodgkin's lymphoma (n=11), myelodysplastic syndrome (n=6), and others (n=11) in the MCFG group and acute leukemia (n=18), chronic myelogenous leukemia (n=6), and others (n=5) in the FLCZ group. The median durations of administration of MCFG and FLCZ were 36 and 34 days, respectively. Prophylactic success, defined as the absence of proven, probable, and possible invasive fungal infection (IFI) until the end of prophylactic therapy was achieved in 36 (87.8%) of the 41 evaluated patients in the MCFG group and in 65.5% of the patients in the FLCZ group (p=0.038). No patients in the MCFG group showed proven or probable IFI, whereas proven or probable IFI was observed in 3 patients in the FLCZ group. Four patients in the MCFG group required dose escalation due to febrile neutropenia. Although one patient in the MCFG group required the discontinuation of MCFG due to allergic skin eruption (grade 2), none of the other patients in either group required dose reduction due to adverse effects.Conclusions: Although the study design was not a prospective randomized trial, our results indicate that the administration of MCFG at a daily dose of 100 mg is promising for prophylactic antifungal therapy in patients undergoing allogeneic SCT.

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Section: Discussioncontrasting

confidence: 52%

Section: Discussionmentioning

confidence: 99%

Administration of micafungin as prophylactic antifungal therapy in patients undergoing allogeneic stem cell transplantation

et al. 2007

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“…However, despite the knowledge of several post-engraftment risk factors associated with late IFD (for example, corticosteroid therapy and GVHD), considered as a guide for risk-adapted antifungal prophylaxis, the usefulness of such prophylaxis beyond the alloSCT engraftment is still controversial. [8][9][10] There are a few studies specifically analyzing the epidemiology and risk factors for IFD after engraftment in alloSCT adult recipients [3][4][5]11 and the potential impact of antifungal prophylaxis in this setting.…”

Section: Introductionmentioning

confidence: 99%

Incidence and risk factors of post-engraftment invasive fungal disease in adult allogeneic hematopoietic stem cell transplant recipients receiving oral azoles prophylaxis

Montesinos

Rodríguez‐Veiga

Boluda

et al. 2015

Bone Marrow Transplant

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Studies that analyze the epidemiology and risk factors for invasive fungal disease (IFD) after engraftment in alloSCT are few in number. This single-center retrospective study included 404 alloSCT adult recipients surviving 440 days who engrafted and were discharged without prior IFD. All patients who received ⩾ 20 mg/day of prednisone were assigned to primary oral prophylaxis (itraconazole or low-dose voriconazole). The primary end point was the cumulative incidence (CI) of probable/proven IFD using the European Organization for Research and Treatment of Cancer and Mycoses Study Group (EORTC/MSG) criteria. The independent prognostic factors after multivariate analyses were used to construct a post-engraftment IFD risk score. The 1-year CI of IFD was 11%. The non-relapse mortality was 40% in those developing IFD and 16% in those who did not. The intent-to-treat analysis showed that 17% of patients abandoned the assigned prophylaxis. Age 440 years, ⩾ 1 previous SCT, pre-engraftment neutropenia 415 days, extensive chronic GVHD and CMV reactivation were independent risk factors. The post-engraftment IFD score stratified patients into low risk (0-1 factor, CI 0.7%), intermediate risk (2 factors, CI 9.9%) and high risk (3-5 factors, CI 24.7%) (P o 0.0001). The antifungal prophylaxis strategy failed to prevent post-engraftment IFD in 11% of alloSCT. Our risk score could be useful to implement risk-adapted strategies using antifungal prophylaxis after engraftment.

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“…El mayor problema en esta serie fue la mala tolerancia de itraconazol reportada por los pacientes. Este inconveniente ha sido observado también en otros estudios que han evidenciado menor frecuencia de infecciones fúngicas con itraconazol comparado con fluconazol (9 vs 25%; p = 0,01), pero una significativa mayor frecuencia de efectos adversos gastrointestinales (24 vs 9%; p = 0,02) 61 ; o necesidad de suspender la terapia con itraconazol por toxicidad, comparado con el uso de fluconazol (36 vs 16%) (p < 0,01) 62 .…”

Section: Uso En Casos Seleccionados Por Factores De Riesgounclassified

Profilaxis antifúngica en niños y adultos sometidos a trasplante de órganos sólidos y de precursores hematopoyéticos

Rabagliati¹,

Santolaya²

2012

Rev. chil. infectol.

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Prophylaxis against fungal infections in solid organ and hematopoietic stem cells transplantationInvasive fungal infections are an important cause of morbidity and mortality in SOT and HSCT recipients. The main species involved are Candida spp. and Aspergillus spp, less frequently Cryptococcus spp., causal agents of mucormycosis and Fusarium spp. Usually occur within the first six months post-transplant, but they do it later, especially during episodes of rejection, which maintains the state of immune system involvement. Prophylaxis recommendations are specific to each type of transplant. In liver transplantation use of fluconazole is recommended only in selected cases by high risk factor for invasive fungal infections (A1). If the patient has a high risk of aspergillosis, there are some suggestions for adults population to use amphotericin B-deoxycholate, liposomal amphotericin B or caspofungin (C2) without being validated none of these recommendations in pediatric population. In adult lung transplant patients where the risk of aspergillosis is higher than in other locations, we recommend universal prophylaxis with itraconazole 200 mg/day, nebulised liposomal amphotericin B or voriconazole (C2), no validated recommendations for pediatrics. In HSCT, universal prophylaxis is recommended only in allogeneic and autologous selected cases. The most accepted indication is fluconazole (A1), and posaconazole (A1) or micafungin (A1) in selected cases with high risk of aspergillosis.Key words: Fungus, Candida, Aspergillus, yeasts, moulds, prophylaxis, amphotericin, fl uconazole, voriconaamphotericin, fluconazole, voriconazole, posaconazole, caspofungin, micafungin, transplants, solid organ transplantation, hematopoietic stem cells transplantation.Palabras clave: Hongos, Candida, Aspergillus, levaduras, hongos filamentosos, profilaxis, anfotericina, fluconazol, voriconazol, posaconazol, caspofungina, micafungina, trasplante, trasplante de órganos sólidos, trasplante de precursores hematopoyéticos. IntroducciónL as infecciones fúngicas constituyen una importante causa de morbilidad en los pacientes receptores de trasplantes de órganos sólidos (TOS) y trasplante de precursores hematopoyéticos (TPH) 1 , generando desafíos diagnósticos y terapéuticos, elevación de los costos de manejo y elevada mortalidad 2,3 . En los receptores de trasplantes, la enfermedad fúngica invasora (EFI) es provocada tanto por hongos levaduriformes como filamentosos, destacando Candida spp. y Aspergillus spp. 2-4 , menos frecuentemente Cryptococcus spp., agentes causales de mucormicosis 5,6 y Fusarium spp. 7 , infecciones por hongos endémicos como Histoplasma capsulatum, Coccidioides immitis, Paracoccidioides brasiliensis, y con menor cuantía dematiáceos como Cladosporium, Cladophialophora, Scopulariopsis, Alternaria, Curvularia y Bipolaris spp 8 .Existen diferencias en la frecuencia de EFI entre los distintos tipos de TOS y TPH; no obstante, algunas características son comunes: en ambos grupos la mayoría de las EFI son producidas por Candida spp. o ...

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Intravenous and Oral Itraconazole versus Intravenous and Oral Fluconazole for Long-Term Antifungal Prophylaxis in Allogeneic Hematopoietic Stem-Cell Transplant Recipients: A Multicenter, Randomized Trial

Abstract: Itraconazole is more effective than fluconazole for long-term prophylaxis of invasive fungal infections after allogeneic hematopoietic stem-cell transplantation. Except for gastrointestinal side effects, itraconazole is well tolerated.

Cited by 363 publications

References 37 publications

Administration of micafungin as prophylactic antifungal therapy in patients undergoing allogeneic stem cell transplantation

Administration of micafungin as prophylactic antifungal therapy in patients undergoing allogeneic stem cell transplantation

Incidence and risk factors of post-engraftment invasive fungal disease in adult allogeneic hematopoietic stem cell transplant recipients receiving oral azoles prophylaxis

Profilaxis antifúngica en niños y adultos sometidos a trasplante de órganos sólidos y de precursores hematopoyéticos

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