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
Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, 00168 Roma, Italy.
IRCCS Ospedale Policlinico San Martino, 16132 Genova, Italy.
Cancers (Basel). 2023 Jul 1;15(13):3457. doi: 10.3390/cancers15133457.
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 [-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.
在本研究中，我们旨在评估接受CPX-351治疗的急性髓系白血病（AML）患者在现实生活环境中的绝对感染风险。该研究纳入了来自SEIFEM组30个意大利血液学中心的所有AML患者，这些患者在2018年7月至2021年6月期间接受了CPX-351治疗。共纳入200例患者。总体而言，共统计了336个CPX-351疗程：所有200例患者接受了第一个诱导周期，18例患者（5%）接受了第二个CPX-351诱导，86例患者（26%）进行了第一个CPX-351巩固周期，32例患者（10%）接受了第二个CPX-351巩固。共记录了249次发热事件：193次发生在第一次或第二次诱导期间，56次发生在第一次或第二次巩固之后。经过诊断检查，92次事件（37%）被归类为不明原因的发热性中性粒细胞减少（FUO），118次（47%）可归类为微生物学确诊感染，39次（17%）可归类为临床确诊感染。总体30天死亡率为14%（28/200）。感染归因死亡率为6%（15/249）。在多变量分析中，对CPX-351治疗无反应是与死亡率显著相关的唯一因素[-值：0.004，OR 0.05，95%CI 0.01-0.39]。我们的研究证实了CPX-351在现实生活环境中的良好安全性，其感染并发症发生率与关键研究相当；尽管中性粒细胞减少持续时间较长，但真菌感染发生率较低，感染相关死亡率也较低。
