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

SIMPLE SUMMARY: CPX-351 has been approved for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML–MRC). The aim of this retrospective study was to evaluate the absolute infectious risk in a real-life setting of 200 AML patients treated with this d...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10341225/
https://www.ncbi.nlm.nih.gov/pubmed/37444567
http://dx.doi.org/10.3390/cancers15133457
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author 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
author_facet 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
author_sort Fianchi, Luana
collection PubMed
description SIMPLE SUMMARY: CPX-351 has been approved for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML–MRC). The aim of this retrospective study was to evaluate the absolute infectious risk in a real-life setting of 200 AML patients treated with this drug. A total of 249 febrile events were recorded in 336 courses of CPX. The attributable mortality–infection rate in our series was 6%, confirming a good safety profile for CPX-351, with an incidence of infectious complications comparable to that of the pivotal studies. The only factor that was significantly associated with mortality in the multivariate analysis was the lack of response to CPX-351 treatment. 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.
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spelling pubmed-103412252023-07-14 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 Cancers (Basel) Article SIMPLE SUMMARY: CPX-351 has been approved for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML–MRC). The aim of this retrospective study was to evaluate the absolute infectious risk in a real-life setting of 200 AML patients treated with this drug. A total of 249 febrile events were recorded in 336 courses of CPX. The attributable mortality–infection rate in our series was 6%, confirming a good safety profile for CPX-351, with an incidence of infectious complications comparable to that of the pivotal studies. The only factor that was significantly associated with mortality in the multivariate analysis was the lack of response to CPX-351 treatment. 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. MDPI 2023-07-01 /pmc/articles/PMC10341225/ /pubmed/37444567 http://dx.doi.org/10.3390/cancers15133457 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
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
Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience
title Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience
title_full Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience
title_fullStr Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience
title_full_unstemmed Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience
title_short Multicenter Observational Retrospective Study on Febrile Events in Patients with Acute Myeloid Leukemia Treated with Cpx-351 in “Real-Life”: The SEIFEM Experience
title_sort multicenter observational retrospective study on febrile events in patients with acute myeloid leukemia treated with cpx-351 in “real-life”: the seifem experience
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10341225/
https://www.ncbi.nlm.nih.gov/pubmed/37444567
http://dx.doi.org/10.3390/cancers15133457
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