The use and efficacy of empirical versus pre-emptive therapy in the management of fungal infections: the HEMA e-Chart Project

• Published in: Haematologica (Roma) Vol. 96; no. 9; pp. 1366 - 1370
• Main Authors: Pagano, L., Caira, M., Nosari, A., Cattaneo, C., Fanci, R., Bonini, A., Vianelli, N., Garzia, M. G., Mancinelli, M., Tosti, M. E., Tumbarello, M., Viale, P., Aversa, F., Rossi, G.
• Format: Journal Article
• Language: English
• Published: Pavia Ferrata Storti Foundation 01.09.2011
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antibiotic Prophylaxis; Antifungal Agents - therapeutic use; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Female; Hematologic and hematopoietic diseases; Hematologic Neoplasms - complications; Hematologic Neoplasms - therapy; Hematopoietic Stem Cell Transplantation - adverse effects; Humans; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Mycoses - drug therapy; Mycoses - etiology; Mycoses - prevention & control; Neutropenia - etiology; Original; Young Adult; Hematology; Mycosis; Treatment efficiency; Malignant hemopathy; empirical antifungal therapy; Infection; Prevention; hematologic malignancies; Antifungal agent; Clinical management; Treatment; pre-emptive antifungal therapy; Comparative study; Cancer
• ISSN: 0390-6078; 1592-8721; 1592-8721
• DOI: 10.3324/haematol.2011.042598

Neutropenic patients with persistent fever despite antibiotic therapy are managed with empirical or pre-emptive antifungal therapy. The aim of the present study was to evaluate the current clinical use and efficacy of these two approaches in patients with high risk hematologic conditions. An electronic medical record system, the "Hema e-Chart", was designed and implemented to collect information prospectively on infectious complications, particularly on invasive fungal diseases, in patients with hematologic malignancies treated with chemotherapy and/or autologous or allogenic hemopoietic stem cell transplantation. The patients were enrolled from Hematology units distributed widely across Italy. Three hundred and ninety-seven adults with hematologic malignancies treated with chemotherapy with persistent fever and suspected invasive fungal disease were evaluable for the study (190 treated had been treated with empirical antifungal therapy and 207 with preemptive antifungal therapy). There was a significantly lower incidence of proven/probable invasive fungal diseases in patients treated with empirical antifungal therapy (n=14, 7.4%) than in patients treated with pre-emptive therapy (n=49, 23.7%) (P<0.001). The rate of deaths attributable to invasive fungal diseases was significantly lower in subjects treated with empirical antifungal therapy (1 case; 7.1%) than in subjects treated with pre-emptive therapy (11 cases; 22.5%) (P=0.002). These data indicate that empirical antifungal treatment decreased the incidence of invasive fungal disease and of attributable mortality with respect to a pre-emptive antifungal approach in neutropenic febrile patients with hematologic malignancies. (ClinicalTrials.gov Identifier: NCT01069887).