Impact of fitness categorization according to SIE/SIES/GITMO criteria in therapy-related and AML-MRC receiving CPX-351
Year: 2025
Type: article
Abstract: ABSTRACT: CPX-351, a novel liposomal formulation of cytarabine and daunorubicin, represents the standard of care in fit patients with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) and therapy-related AML (t-AML). Considering its better safety profile than conventional intensive chemotherapy, we investigated its cost-to-benefit ratio, in terms of overall survival and of mortality, in a large multicentric series of AML-MRC and t-AML receiving CPX-351 outside clinical trials between 2019 and 2022. Patients were classified as fit or unfit for intensive chemotherapy through a comprehensive evaluation of age, comorbidities, and performance status by adopting Italian Society of Hematology/Italian Society of Experimental Hematology/Gruppo Italiano per il Trapianto di Midollo Osseo (SIE/SIES/GITMO) criteria. Disease risk was defined according to the European LeukemiaNet 2017 classification. Before treatment start, 328 of 403 (81.4%) patients were classified as fit and 75 of 403 (18.6%) as unfit. Three hundred and ninety-six had a full genetic/cytogenetic profile, with 17 (4%) being categorized as favorable risk, 162 (41%) intermediate risk, and 217 (55%) adverse risk according to European LeukemiaNet 2017. After induction, 230 of 403 (57.1%) patients achieved complete remission, with no differences between fit (57.3%) and unfit (56%) patients. However, the 2 groups significantly differed in terms of survival (median overall survival, 18 months vs 8 months for fit and unfit patients, respectively) and of 28- and 100-day mortality (4.6% vs 10.7% at 28 days and 14.3% vs 32% at 100 days for fit and unfit patients, respectively). In conclusion, the SIE/SIES/GITMO criteria distinguished patient subgroups with different short- and long-term outcomes after treatment with CPX-351. The update or design of dedicated fitness criteria could represent a future and valid strategy to optimize the use of this specific treatment.
Source: Blood Advances
Authors: Raffaele Palmieri, Fabio Guolo, Luana Fianchi, Felicetto Ferrara, Paola Minetto, Maria Paola Martelli, Carola Riva, Patrizia Chiusolo, Michela Rondoni, Saveria Capria, Clara Minotti, Federica Pilo, Salvatore Perrone, Andrea Corbingi, Francesco Grimaldi, Giulia De Luca, Carla Fili, Caterina Alati, Francesco Mannelli, Federica Lessi, Francesco Marchesi, Lorenzo Brunetti, Debora Capelli, Anna Lina Piccioni, Calogero Vetro, Fanny Erika Palumbo, Carla Mazzone, Alessandra Sperotto, Giovanni Luzi, Michela Dargenio, Sabrina Mariani, Marco Cerrano, Antonino Mulè, Ambra Di Veroli, Elisa Meddi, Federico Moretti, Cristina Papayannidis, Alessandro Isidori, Antonella Ferrari, Sara Galimberti, Daniela Cilloni, Massimo Breccia, Francesco Lanza, Michele Gottardi, Roberto Cairoli, Anna Candoni, Livio Pagano, Elisabetta Todisco, Roberto Massimo Lemoli, Adriano Venditti, Francesco Buccisano
Institutions: University of Rome Tor Vergata, Ospedale Policlinico San Martino, University of Genoa, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Ospedale Antonio Cardarelli, Istituti di Ricovero e Cura a Carattere Scientifico, Azienda Ospedaliera di Perugia, University of Bologna, Sapienza University of Rome, Azienda Ospedaliera G. Brotzu, Ospedale Santa Maria Goretti, Federico II University Hospital, University of Naples Federico II, University of Udine, Azienda ospedaliera "Bianchi-Melacrino-Morelli", University of Florence, Azienda Ospedale - Università Padova, Istituti Fisioterapici Ospitalieri, Instituto Nazionale Tumori Regina Elena, Azienda Ospedaliero-Universitaria delle Marche, Azienda Ospedaliera San Giovanni Addolorata, Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", Azienda Sanitaria dell'Alto Adige, St. Eugenio Hospital, Istituto Oncologico Veneto, Azienda Ospedaliera San Camillo-Forlanini, Ospedale Vito Fazzi, Azienda Ospedaliera Sant'Andrea, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, Ospedale Vincenzo Cervello, Ospedale di Belcolle, Istituto di Ematologia di Bologna, Ospedali Riuniti Marche Nord, University of Pisa, A. O. Ordine Mauriziano di Torino, Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, University of Modena and Reggio Emilia, Ospedale di Circolo di Busto Arsizio, Azienda Socio Sanitaria Territoriale della Valle Olona
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,800
OpenAlex ID: W4417028947