Livio Pagano1, Luisa Verga2, Alessandro Busca3, Bruno Martino4, Maria Enza Mitra5, Rosa Fanci6, Stelvio Ballanti7, Marco Picardi8, Carlo Castagnola9, Chiara Cattaneo10, Gianpaolo Nadali11, Annamaria Nosari12, Anna Candoni13, Morena Caira14, Prassede Salutari15, Federica Lessi16, Franco Aversa17, Mario Tumbarello18. 1. Istituto di Ematologia, Università Cattolica del Sacro Cuore, Roma, Italy lpagano@rm.unicatt.it. 2. Unità di Ematologia, Università di Milano-Bicocca, Ospedale S.Gerardo, Monza, Italy. 3. Dipartimento di Ematologia, Ospedale S.Giovanni Battista, Torino, Italy. 4. Divisione di Ematologia, Azienda Ospedaliera 'Bianchi Melacrino Morelli', Reggio Calabria, Italy. 5. Divisione di Ematologia e TMO, Policlinico di Palermo, Italy. 6. Unità Operativa di Ematologia, Università di Firenze, Italy. 7. Istituto di Ematologia, Università di Perugia, Italy. 8. Divisione di Ematologia, Dipartimento di Medicina Clinica e Chirurgia, Università Federico II, Napoli, Italy. 9. Dipartimento Onco-Ematologico, Fondazione ICRRS Policlinico San Matteo, Pavia, Italy. 10. Divisione di Ematologia, Spedali Civili di Brescia, Italy. 11. UOC Ematologia, Azienda Ospedaliera Universitaria Integrata di Verona, Italy. 12. Divisione di Ematologia e Centro Trapianti Midollo, Ospedale Niguarda Ca' Granda, Milano, Italy. 13. Clinica di Ematologia, Università di Udine, Italy. 14. Istituto di Ematologia, Università Cattolica del Sacro Cuore, Roma, Italy. 15. Dipartimento di Ematologia Clinica, Ospedale Santo Spirito, Pescara, Italy. 16. Ematologia ed Immunologia Clinica, Dipartimento di Medicina, Università di Padova, Italy. 17. Istituto di Ematologia, Università di Parma, Italy. 18. Istituto di Malattie Infettive, Università Cattolica del Sacro Cuore, Roma, Italy.
Abstract
OBJECTIVES: To investigate the incidence, treatment and outcome of breakthrough invasive fungal infections (IFIs) in adult acute myeloid leukaemia (AML) patients after posaconazole prophylaxis. METHODS: From January 2010 to April 2012, all consecutive patients with newly diagnosed AML were prospectively registered at 33 participating Italian centres. All cases of IFIs occurring within 30 days after the end of the first induction chemotherapy were recorded. The strategy of antifungal treatment (empirical, pre-emptive or targeted) and the drugs used were analysed. ClinicalTrials.gov code: NCT01315925. RESULTS: In total, 1192 patients with newly diagnosed AML were enrolled in the study, of whom 510 received posaconazole prophylaxis and were included in the present analysis. Of these patients, 140 (27%) needed systemic antifungal treatment. Among the 127 evaluable cases, an empirical approach was utilized in 102 patients (80%), a pre-emptive approach in 19 patients (15%) and targeted therapy in 6 patients (5%). Only five patients died of IFIs (three in the empirical group and two in the targeted group; 4%). A critical review of IFI diagnoses at 30 days demonstrated that among the patients treated empirically, ∼30% were not affected by IFIs but rather only by fever of unidentified origin. A comparison between the empirical and the pre-emptive groups showed no significant differences regarding the attributable and overall mortalities. CONCLUSIONS: This study confirms that posaconazole prophylaxis reduces the incidence of breakthrough IFIs and does not modify the efficacy of subsequent systemic antifungal treatment, regardless of the approach (empirical or pre-emptive) or the antifungal drug used.
OBJECTIVES: To investigate the incidence, treatment and outcome of breakthrough invasive fungal infections (IFIs) in adult acute myeloid leukaemia (AML) patients after posaconazole prophylaxis. METHODS: From January 2010 to April 2012, all consecutive patients with newly diagnosed AML were prospectively registered at 33 participating Italian centres. All cases of IFIs occurring within 30 days after the end of the first induction chemotherapy were recorded. The strategy of antifungal treatment (empirical, pre-emptive or targeted) and the drugs used were analysed. ClinicalTrials.gov code: NCT01315925. RESULTS: In total, 1192 patients with newly diagnosed AML were enrolled in the study, of whom 510 received posaconazole prophylaxis and were included in the present analysis. Of these patients, 140 (27%) needed systemic antifungal treatment. Among the 127 evaluable cases, an empirical approach was utilized in 102 patients (80%), a pre-emptive approach in 19 patients (15%) and targeted therapy in 6 patients (5%). Only five patients died of IFIs (three in the empirical group and two in the targeted group; 4%). A critical review of IFI diagnoses at 30 days demonstrated that among the patients treated empirically, ∼30% were not affected by IFIs but rather only by fever of unidentified origin. A comparison between the empirical and the pre-emptive groups showed no significant differences regarding the attributable and overall mortalities. CONCLUSIONS: This study confirms that posaconazole prophylaxis reduces the incidence of breakthrough IFIs and does not modify the efficacy of subsequent systemic antifungal treatment, regardless of the approach (empirical or pre-emptive) or the antifungal drug used.
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