: 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.

Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in "Real-Life": The SEIFEM Experience / Fianchi, Luana; Guolo, Fabio; Marchesi, Francesco; Cattaneo, Chiara; Gottardi, Michele; Restuccia, Francesco; Candoni, Anna; Ortu La Barbera, Elettra; Fazzi, Rita; Pasciolla, Crescenza; Finizio, Olimpia; Fracchiolla, Nicola; Delia, Mario; Lessi, Federica; Dargenio, Michelina; Bonuomo, Valentina; Del Principe, Maria Ilaria; Zappasodi, Patrizia; Picardi, Marco; Basilico, Claudia; Piedimonte, Monica; Minetto, Paola; Giordano, Antonio; Chiusolo, Patrizia; Prezioso, Lucia; Buquicchio, Caterina; Melillo, Lorella Maria Antonia; Zama, Daniele; Farina, Francesca; Mancini, Valentina; Terrenato, Irene; Rondoni, Michela; Urbino, Irene; Tumbarello, Mario; Busca, Alessandro; Pagano, Livio. - In: CANCERS. - ISSN 2072-6694. - 15:13(2023), pp. 3457-3465. [10.3390/cancers15133457]

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

Candoni, Anna;
2023

Abstract

: 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.
2023
15
13
3457
3465
Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in "Real-Life": The SEIFEM Experience / Fianchi, Luana; Guolo, Fabio; Marchesi, Francesco; Cattaneo, Chiara; Gottardi, Michele; Restuccia, Francesco; Candoni, Anna; Ortu La Barbera, Elettra; Fazzi, Rita; Pasciolla, Crescenza; Finizio, Olimpia; Fracchiolla, Nicola; Delia, Mario; Lessi, Federica; Dargenio, Michelina; Bonuomo, Valentina; Del Principe, Maria Ilaria; Zappasodi, Patrizia; Picardi, Marco; Basilico, Claudia; Piedimonte, Monica; Minetto, Paola; Giordano, Antonio; Chiusolo, Patrizia; Prezioso, Lucia; Buquicchio, Caterina; Melillo, Lorella Maria Antonia; Zama, Daniele; Farina, Francesca; Mancini, Valentina; Terrenato, Irene; Rondoni, Michela; Urbino, Irene; Tumbarello, Mario; Busca, Alessandro; Pagano, Livio. - In: CANCERS. - ISSN 2072-6694. - 15:13(2023), pp. 3457-3465. [10.3390/cancers15133457]
Fianchi, Luana; Guolo, Fabio; Marchesi, Francesco; Cattaneo, Chiara; Gottardi, Michele; Restuccia, Francesco; Candoni, Anna; Ortu La Barbera, Elettra; Fazzi, Rita; Pasciolla, Crescenza; Finizio, Olimpia; Fracchiolla, Nicola; Delia, Mario; Lessi, Federica; Dargenio, Michelina; Bonuomo, Valentina; Del Principe, Maria Ilaria; Zappasodi, Patrizia; Picardi, Marco; Basilico, Claudia; Piedimonte, Monica; Minetto, Paola; Giordano, Antonio; Chiusolo, Patrizia; Prezioso, Lucia; Buquicchio, Caterina; Melillo, Lorella Maria Antonia; Zama, Daniele; Farina, Francesca; Mancini, Valentina; Terrenato, Irene; Rondoni, Michela; Urbino, Irene; Tumbarello, Mario; Busca, Alessandro; Pagano, Livio
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