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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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. |
format | Online Article Text |
id | pubmed-10341225 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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