TY - JOUR
T1 - Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience
AU - Fianchi, Luana
AU - Guolo, Fabio
AU - Marchesi, Francesco
AU - Cattaneo, Chiara
AU - Gottardi, Michele
AU - Restuccia, Francesco
AU - Candoni, Anna
AU - Ortu La Barbera, Elettra
AU - Fazzi, Rita
AU - Pasciolla, Crescenza
AU - Finizio, Olimpia
AU - Fracchiolla, Nicola
AU - Delia, Mario
AU - Lessi, Federica
AU - Dargenio, Michelina
AU - Bonuomo, Valentina
AU - Del Principe, Maria Ilaria
AU - Zappasodi, Patrizia
AU - Picardi, Marco
AU - Basilico, Claudia
AU - Piedimonte, Monica
AU - Minetto, Paola
AU - Giordano, Antonio
AU - Chiusolo, Patrizia
AU - Prezioso, Lucia
AU - Buquicchio, Caterina
AU - Melillo, Lorella Maria Antonia
AU - Zama, Daniele
AU - Farina, Francesca
AU - Mancini, Valentina
AU - Terrenato, Irene
AU - Rondoni, Michela
AU - Urbino, Irene
AU - Tumbarello, Mario
AU - Busca, Alessandro
AU - Pagano, Livio
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - CPX-351 therapy
KW - febrile events
KW - secondary acute myeloid leukemia
KW - CPX-351 therapy
KW - febrile events
KW - secondary acute myeloid leukemia
UR - http://hdl.handle.net/10807/260256
U2 - 10.3390/cancers15133457
DO - 10.3390/cancers15133457
M3 - Article
SN - 2072-6694
VL - 15
SP - 3457
EP - 3467
JO - Cancers
JF - Cancers
ER -