Voriconazole for secondary prophylaxis of invasive fungal infections in allogeneic stem cell transplant recipients: results of the VOSIFI study.
dc.contributor.author | Cordonnier, C | |
dc.contributor.author | Rovira, M | |
dc.contributor.author | Maertens, J | |
dc.contributor.author | Olavarria, E | |
dc.contributor.author | Faucher, C | |
dc.contributor.author | Bilger, K | |
dc.contributor.author | Pigneux, A | |
dc.contributor.author | Cornely, O | |
dc.contributor.author | Ullmann, A | |
dc.contributor.author | Bofarull, R | |
dc.contributor.author | De la Cámara, R | |
dc.contributor.author | Weisser, M | |
dc.contributor.author | Liakopoulou, Effie F | |
dc.contributor.author | Abecasis, M | |
dc.contributor.author | Heussel, C | |
dc.contributor.author | Pineau, M | |
dc.contributor.author | Ljungman, P | |
dc.contributor.author | Einsele, H | |
dc.date.accessioned | 2010-11-18T16:53:24Z | |
dc.date.available | 2010-11-18T16:53:24Z | |
dc.date.issued | 2010-10 | |
dc.identifier.citation | Voriconazole for secondary prophylaxis of invasive fungal infections in allogeneic stem cell transplant recipients: results of the VOSIFI study. 2010, 95 (10):1762-8 Haematologica | en |
dc.identifier.issn | 1592-8721 | |
dc.identifier.pmid | 20634495 | |
dc.identifier.doi | 10.3324/haematol.2009.020073 | |
dc.identifier.uri | http://hdl.handle.net/10541/115837 | |
dc.description.abstract | BACKGROUND: Recurrence of prior invasive fungal infection (relapse rate of 30-50%) limits the success of stem cell transplantation. Secondary prophylaxis could reduce disease burden and improve survival. DESIGN AND METHODS: A prospective, open-label, multicenter trial was conducted evaluating voriconazole (4 mg/kg/12 h intravenously or 200 mg/12 h orally) as secondary antifungal prophylaxis in allogeneic stem cell transplant recipients with previous proven or probable invasive fungal infection. Voriconazole was started 48 h or more after completion of conditioning chemotherapy and was planned to be continued for 100-150 days. Patients were followed for 12 months. The primary end-point of the study was the incidence of proven or probable invasive fungal infection. RESULTS: Forty-five patients were enrolled, 41 of whom had acute leukemia. Previous invasive fungal infections were proven or probable aspergillosis (n=31), proven candidiasis (n=5) and other proven or probable infections (n=6); prior infection could not be confirmed in three patients. The median duration of voriconazole prophylaxis was 94 days. Eleven patients (24%) died within 12 months of transplantation, but only one due to systemic fungal disease. Three invasive fungal infections occurred post-transplant: two relapses (one candidemia and one fatal scedosporiosis) and one new zygomycosis in a patient with previous aspergillosis. The 1-year cumulative incidence of invasive fungal disease was 6.7±3.6%. Two patients were withdrawn from the study due to treatment-related adverse events (i.e. liver toxicity). CONCLUSIONS: Voriconazole appears to be safe and effective for secondary prophylaxis of systemic fungal infection after allogeneic stem cell transplantation. The observed incidence of 6.7% (with one attributable death) is considerably lower than the relapse rate reported in historical controls, thus suggesting that voriconazole is a promising prophylactic agent in this population. | |
dc.language.iso | en | en |
dc.subject | Voriconazole | en |
dc.subject | Prophylaxis | en |
dc.subject | Fungal Infection | en |
dc.subject | Allogeneic Stem Cell Transplantation | en |
dc.title | Voriconazole for secondary prophylaxis of invasive fungal infections in allogeneic stem cell transplant recipients: results of the VOSIFI study. | en |
dc.type | Article | en |
dc.contributor.department | Service d'Hématologie Clinique, Hôpital Henri Mondor, 51 Av. Maréchal de Lattre de Tassigny, Créteil, France. carlcord@club-internet.fr | en |
dc.identifier.journal | Haematologica | en |
html.description.abstract | BACKGROUND: Recurrence of prior invasive fungal infection (relapse rate of 30-50%) limits the success of stem cell transplantation. Secondary prophylaxis could reduce disease burden and improve survival. DESIGN AND METHODS: A prospective, open-label, multicenter trial was conducted evaluating voriconazole (4 mg/kg/12 h intravenously or 200 mg/12 h orally) as secondary antifungal prophylaxis in allogeneic stem cell transplant recipients with previous proven or probable invasive fungal infection. Voriconazole was started 48 h or more after completion of conditioning chemotherapy and was planned to be continued for 100-150 days. Patients were followed for 12 months. The primary end-point of the study was the incidence of proven or probable invasive fungal infection. RESULTS: Forty-five patients were enrolled, 41 of whom had acute leukemia. Previous invasive fungal infections were proven or probable aspergillosis (n=31), proven candidiasis (n=5) and other proven or probable infections (n=6); prior infection could not be confirmed in three patients. The median duration of voriconazole prophylaxis was 94 days. Eleven patients (24%) died within 12 months of transplantation, but only one due to systemic fungal disease. Three invasive fungal infections occurred post-transplant: two relapses (one candidemia and one fatal scedosporiosis) and one new zygomycosis in a patient with previous aspergillosis. The 1-year cumulative incidence of invasive fungal disease was 6.7±3.6%. Two patients were withdrawn from the study due to treatment-related adverse events (i.e. liver toxicity). CONCLUSIONS: Voriconazole appears to be safe and effective for secondary prophylaxis of systemic fungal infection after allogeneic stem cell transplantation. The observed incidence of 6.7% (with one attributable death) is considerably lower than the relapse rate reported in historical controls, thus suggesting that voriconazole is a promising prophylactic agent in this population. |