Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience

Autor: Pagano, Luana Fianchi, Fabio Guolo, Francesco Marchesi, Chiara Cattaneo, Michele Gottardi, Francesco Restuccia, Anna Candoni, Elettra Ortu La Barbera, Rita Fazzi, Crescenza Pasciolla, Olimpia Finizio, Nicola Fracchiolla, Mario Delia, Federica Lessi, Michelina Dargenio, Valentina Bonuomo, Maria Ilaria Del Principe, Patrizia Zappasodi, Marco Picardi, Claudia Basilico, Monica Piedimonte, Paola Minetto, Antonio Giordano, Patrizia Chiusolo, Lucia Prezioso, Caterina Buquicchio, Lorella Maria Antonia Melillo, Daniele Zama, Francesca Farina, Valentina Mancini, Irene Terrenato, Michela Rondoni, Irene Urbino, Mario Tumbarello, Alessandro Busca, Livio
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Cancers; Volume 15; Issue 13; Pages: 3457
ISSN: 2072-6694
DOI: 10.3390/cancers15133457
Popis: In the present study, we aimed to evaluate the absolute risk of infection in the real-life setting of AML patients treated with CPX-351. The study included all patients with AML from 30 Italian hematology centers of the SEIFEM group who received CPX-351 from July 2018 to June 2021. There were 200 patients included. Overall, 336 CPX-351 courses were counted: all 200 patients received the first induction cycle, 18 patients (5%) received a second CPX-351 induction, while 86 patients (26%) proceeded with the first CPX-351 consolidation cycle, and 32 patients (10%) received a second CPX-351 consolidation. A total of 249 febrile events were recorded: 193 during the first or second induction, and 56 after the first or second consolidation. After the diagnostic work-up, 92 events (37%) were classified as febrile neutropenia of unknown origin (FUO), 118 (47%) were classifiable as microbiologically documented infections, and 39 (17%) were classifiable as clinically documented infections. The overall 30-day mortality rate was 14% (28/200). The attributable mortality–infection rate was 6% (15/249). A lack of response to the CPX-351 treatment was the only factor significantly associated with mortality in the multivariate analysis [p-value: 0.004, OR 0.05, 95% CI 0.01–0.39]. Our study confirms the good safety profile of CPX-351 in a real-life setting, with an incidence of infectious complications comparable to that of the pivotal studies; despite prolonged neutropenia, the incidence of fungal infections was low, as was infection-related mortality.
Databáze: OpenAIRE
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