Pegaspargase administration and tolerability in patients aged 55 years or older with acute lymphoblastic leukemia treated with the LAL1913 program. A subanalysis of the Campus ALL group

The adoption of pediatric-inspired regimens for the treatment of Ph-negative acute lymphoblastic leukemia (ALL) in adults has improved prognosis. However, the feasibility of these intensive regimens in older patients is limited, due to the increased incidence of therapy-related side effects, including those related to asparaginase. In this sub-analysis carried out by the Campus ALL network, 90 ALL patients aged 55 or more (median age 59 years) homogeneously treated in real-life according to the GIMEMA LAL1913 program, were analyzed to evaluate the feasibility and tolerability of pegaspargase (PEG-ASP) treatment. Among the 90 patients analyzed, 86 (96%) received PEG-ASP at least in one of the first two courses (C1-C2) of chemotherapy and were evaluated for toxicity and outcome. In detail, 51 patients received PEG-ASP in both courses and 35 in either C1 or C2. The most common adverse event was hepatic toxicity (HT), with 38% of patients experiencing any grade of HT at C1 (HT grade ≥ 3, 19%) and 23% at C2 (HT grade ≥ 3, 9%). Additionally, HT at C1 was the primary reason for withholding PEG-ASP at C2. Coagulopathy was the second most frequent toxicity (any grade of toxicity in 26% of patients at C1 and in 20% at C2). No deaths directly related to PEG-ASP therapy were reported. The CR rate after C1 and C3 was 94% and 93%, respectively. MRD negativity rate was 40% and 68%, respectively. The OS and DFS probability at 3 years was 54% and 47%, respectively. PEG-ASP administration in older ALL patients is feasible, but HT is a concern, being the major cause of PEG-ASP interruption. Therefore, a dose adjustment, according to age and concomitant comorbidities, is advisable to balance PEG-ASP efficacy with its toxicity.

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Journal
Annals of Hematology
Published
2025-08-27
DOI
https://doi.org/10.1007/s00277-025-06550-4
Primary Topic
Acute Lymphoblastic Leukemia research
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article
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article

Pegaspargase administration and tolerability in patients aged 55 years or older with acute lymphoblastic leukemia treated with the LAL1913 program. A subanalysis of the Campus ALL group

Fabio Forghieri, Anna Candoni, Valentina Mancini, Francesco Grimaldi et al.
Annals of Hematology
Acute Lymphoblastic Leukemia research
article

Pegaspargase administration and tolerability in patients aged 55 years or older with acute lymphoblastic leukemia treated with the LAL1913 program. A subanalysis of the Campus ALL group

Fabio Forghieri, Anna Candoni, Valentina Mancini, Francesco Grimaldi, Fabio Guolo, Alessandro Cignetti, Michelina Dargenio, Benedetta Cambò, Nicola Fracchiolla, Silvia Imbergamo, Federico Mosna, Matteo Leoncin, Sabina Chiaretti, Marco Cerrano, Felicetto Ferrara, Renato Fanin, Cristina Papayannidis, Matteo Olivi, Federico Lussana, Monia Lunghi, Davide Lazzarotto, Lara Aprile, Patrizia Zappasodi, Marzia Defina, Paola Minetto, Massimiliano Bonifacio, Antonio Curti, Silvia Trappolini, Crescenza Pasciolla, Maria Ciccone, Giovanni Pizzolo, Matteo Piccini, Mario Delia, Carla Mazzone, Antonino Mulè, Monica Fumagalli, Lidia Santoro, Endri Mauro, Matteo Fanin, Robin Foà, Anna Maria Testi
article en

Abstract

The adoption of pediatric-inspired regimens for the treatment of Ph-negative acute lymphoblastic leukemia (ALL) in adults has improved prognosis. However, the feasibility of these intensive regimens in older patients is limited, due to the increased incidence of therapy-related side effects, including those related to asparaginase. In this sub-analysis carried out by the Campus ALL network, 90 ALL patients aged 55 or more (median age 59 years) homogeneously treated in real-life according to the GIMEMA LAL1913 program, were analyzed to evaluate the feasibility and tolerability of pegaspargase (PEG-ASP) treatment. Among the 90 patients analyzed, 86 (96%) received PEG-ASP at least in one of the first two courses (C1-C2) of chemotherapy and were evaluated for toxicity and outcome. In detail, 51 patients received PEG-ASP in both courses and 35 in either C1 or C2. The most common adverse event was hepatic toxicity (HT), with 38% of patients experiencing any grade of HT at C1 (HT grade ≥ 3, 19%) and 23% at C2 (HT grade ≥ 3, 9%). Additionally, HT at C1 was the primary reason for withholding PEG-ASP at C2. Coagulopathy was the second most frequent toxicity (any grade of toxicity in 26% of patients at C1 and in 20% at C2). No deaths directly related to PEG-ASP therapy were reported. The CR rate after C1 and C3 was 94% and 93%, respectively. MRD negativity rate was 40% and 68%, respectively. The OS and DFS probability at 3 years was 54% and 47%, respectively. PEG-ASP administration in older ALL patients is feasible, but HT is a concern, being the major cause of PEG-ASP interruption. Therefore, a dose adjustment, according to age and concomitant comorbidities, is advisable to balance PEG-ASP efficacy with its toxicity.

Annals of HematologyVol. 104(11)
University of Verona (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), University of Parma (IT), University of Udine (IT), University of Padua (IT), Regione Campania (IT), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Maggiore (IT), Ospedale Antonio Cardarelli (IT), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), Azienda Ospedaliera Universitaria Integrata Verona (IT), Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT), Ospedale Vincenzo Cervello (IT), Azienda Unità Sanitaria Locale di Ferrara (IT), Ospedale Papa Giovanni XXIII (IT), Azienda Ospedaliero Universitaria Ospedali Riuniti (IT), Azienda Ospedaliero-Universitaria di Modena (IT), Azienda Ospedaliera S.Giuseppe Moscati (IT), Azienda Ospedaliero-Universitaria Careggi (IT), Federico II University Hospital (IT), Istituto di Ematologia di Bologna (IT), Presidio Ospedaliero (IT), Arcispedale Sant'Anna (IT), A. O. Ordine Mauriziano di Torino (IT), Istituto Tumori Bari (IT), Azienda Ospedaliera Universitaria Senese (IT), St. Eugenio Hospital (IT), Ospedale dell' Angelo (IT), Ca' Foncello Hospital (IT), Ospedale Policlinico San Martino (IT), Policlinico San Matteo Fondazione (IT), Ospedale Vito Fazzi (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Istituto Nazionale di Fisica Nucleare, Sezione di Roma I (IT), Gruppo Italiano per il Trapianto di Midollo Osseo (IT), Ospedali Riuniti Umberto I (IT), University of Naples Federico II (IT), University of Genoa (IT), Sapienza University of Rome (IT)
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Openalex Percentile: Top 69%
Acute Lymphoblastic Leukemia research
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