Outcome of 421 adult patients with Philadelphia-negative acute lymphoblastic leukemia treated under an intensive program inspired by the GIMEMA LAL1913 clinical trial: a Campus ALL study

Autor: Davide Lazzarotto, Marco Cerrano, Cristina Papayannidis, Sabina Chiaretti, Federico Mosna, Nicola Fracchiolla, Patrizia Zappasodi, Silvia Imbergamo, Maria Ilaria Del Principe, Monia Lunghi, Federico Lussana, Matteo Piccini, Monica Fumagalli, Michelina Dargenio, Prassede Salutari, Fabio Forghieri, Teresa Giulia Da Molin, Massimiliano Bonifacio, Matteo Olivi, Fabio Giglio, Silvia Trappolini, Matteo Leoncin, Antonino Mule, Mario Delia, Crescenza Pasciolla, Francesco Grimaldi, Benedetta Cambo, Lidia Santoro, Fabio Guolo, Paola Minetto, Marzia Defina, Patrizia Chiusolo, Matteo Fanin, Endri Mauro, Lara Aprile, Carla Mazzone, Fabio Trastulli, Maria Ciccone, Marco De Gobbi, Alessandro Cignetti, Eleonora De Bellis, Valentina Mancini, Alfonso Piciocchi, Marco Vignetti, Giovanni Marsili, Irene Della Starza, Renato Fanin, Mario Luppi, Felicetto Ferrara, Giovanni Pizzolo, Renato Bassan, Robin Foa, Anna Candoni
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Haematologica, Vol 999, Iss 1 (2024)
Druh dokumentu: article
ISSN: 0390-6078
1592-8721
DOI: 10.3324/haematol.2024.285638
Popis: The introduction of pediatric-inspired regimens in adult Philadelphia-negative acute lymphoblastic leukemia (Ph-ALL) has significantly improved patients’ prognosis. Within the Campus ALL network we analyzed the outcome of adult Ph-ALL patients treated according to the GIMEMA LAL1913 protocol outside the clinical trial, to compare the real-life data with the study results. We included 421 consecutive patients, with a median age of 42 years. The complete remission (CR) rate after the first course of chemotherapy was 94% and a measurable residual disease (MRD) negativity after the third course was achieved in 72% of patients. The 3-year overall survival (OS) and disease-free survival (DFS) were 67% and 57%, respectively. In a multivariate analysis, MRD positivity negatively influenced DFS. In a time-dependent analysis including only very high risk (VHR) and MRD positive cases, transplanted (HSCT) patients had a significantly better DFS than non-HSCT ones (P=0.0017). During induction, grade ≥2 pegaspargase-related hepato-toxicity was observed in 25% of patients (vs 12% in the GIMEMA LAL1913 trial, P=0.0003). In this large real-life cohort of Ph-ALL, we confirmed the very high CR rate and a superimposable OS and DFS compared to the GIMEMA LAL1913 clinical trial: CR rate after C1 94% vs 85%, P=0.0004; 3-year OS 67% vs 67%, P=0.94; 3-year DFS 57% vs 63%, P=0.17. HSCT confirms its important role in VHR and MRD-positive patients. The rate of pegaspargase-related toxicity was significantly higher in the real-life setting, emphasizing the importance of dose adjustment in the presence of risk factors to avoid excessive toxicity.
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