Impact of fitness categorization according to SIE/SIES/GITMO criteria in therapy-related and AML-MRC receiving CPX-351

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.

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Journal
Blood Advances
Published
2025-12-05
DOI
https://doi.org/10.1182/bloodadvances.2025017089
Primary Topic
Acute Myeloid Leukemia Research
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article
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article

Impact of fitness categorization according to SIE/SIES/GITMO criteria in therapy-related and AML-MRC receiving CPX-351

Francesco Buccisano, Anna Candoni, Francesco Grimaldi, Fabio Guolo et al.
Blood Advances
Acute Myeloid Leukemia Research
article

Impact of fitness categorization according to SIE/SIES/GITMO criteria in therapy-related and AML-MRC receiving CPX-351

Francesco Buccisano, Anna Candoni, Francesco Grimaldi, Fabio Guolo, Roberto Massimo Lemoli, Michelina Dargenio, Federica Pilo, Michela Rondoni, Elisabetta Todisco, Michele Gottardi, Alessandra Sperotto, Francesco Lanza, Roberto Cairoli, Daniela Cilloni, Federica Lessi, Francesco Mannelli, Calogero Vetro, Francesco Marchesi, Patrizia Chiusolo, Marco Cerrano, Felicetto Ferrara, Clara Minotti, Cristina Papayannidis, Livio Pagano, Ambra Di Veroli, Luana Fianchi, Carla Mazzone, Federico Moretti, Giovanni Luzi, Debora Capelli, Raffaele Palmieri, Alessandro Isidori, Paola Minetto, Elisa Meddi, Andrea Corbingi, Lorenzo Brunetti, Anna Lina Piccioni, Carola Riva, Salvatore Perrone, Maria Paola Martelli, Massimo Breccia, Antonino Mulè, Giulia De Luca, Saveria Capria, Sabrina Mariani, Sara Galimberti, Fanny Erika Palumbo, Caterina Alati, Antonella Ferrari, Carla Filì, Adriano Venditti
article en

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.

Blood AdvancesVol. 10(4)
Università Cattolica del Sacro Cuore (IT), University of Pisa (IT), University of Rome Tor Vergata (IT), University of Modena and Reggio Emilia (IT), University of Udine (IT), Azienda Ospedaliera San Giovanni Addolorata (IT), Agostino Gemelli University Polyclinic (IT), Accademia di Belle Arti di Frosinone (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Antonio Cardarelli (IT), Azienda Ospedaliera di Perugia (IT), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), Azienda ospedaliera "Bianchi-Melacrino-Morelli" (IT), Ospedale Vincenzo Cervello (IT), Azienda Sanitaria di Firenze (IT), Ospedali Riuniti di Ancona (IT), Ospedale di Santo Spirito (IT), Azienda Unità Sanitaria Locale Della Romagna (IT), Fatebenefratelli Hospital (IT), Azienda Ospedaliero-Universitaria di Modena (IT), Istituto Oncologico Veneto (IT), Ospedale Santa Maria (IT), Ospedali Riuniti Marche Nord (IT), Federico II University Hospital (IT), Istituto di Ematologia di Bologna (IT), Azienda USL di Bologna (IT), Azienda Ospedaliera Sant'Andrea (IT), Ospedale di Circolo di Busto Arsizio (IT), Ospedale di Belcolle (IT), A. O. Ordine Mauriziano di Torino (IT), Policlinico Universitario di Catania (IT), Istituti Fisioterapici Ospitalieri (IT), Ospedale Santa Maria Goretti (IT), St. Eugenio Hospital (IT), Ospedale Policlinico San Martino (IT), Azienda Ospedale - Università Padova (IT), Policlinico San Matteo Fondazione (IT), Ospedale Vito Fazzi (IT), Carlo Forlanini Hospital (IT), Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" (IT), Azienda Ospedaliera G. Brotzu (IT), University of Florence (IT), Misericordia University (US), University of Naples Federico II (IT), University of Genoa (IT), Sapienza University of Rome (IT)
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Acute Myeloid Leukemia Research
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