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.

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 / Lazzarotto, Davide; Cerrano, Marco; Papayannidis, Cristina; Chiaretti, Sabina; Mosna, Federico; Fracchiolla, Nicola; Zappasodi, Patrizia; Imbergamo, Silvia; Del Principe, Maria Ilaria; Lunghi, Monia; Lussana, Federico; Piccini, Matteo; Fumagalli, Monica; Dargenio, Michelina; Salutari, Prassede; Forghieri, Fabio; Da Molin, Teresa Giulia; Bonifacio, Massimiliano; Olivi, Matteo; Giglio, Fabio; Trappolini, Silvia; Leoncin, Matteo; Mule, Antonino; Delia, Mario; Pasciolla, Crescenza; Grimaldi, Francesco; Cambo, Benedetta; Santoro, Lidia; Guolo, Fabio; Minetto, Paola; Defina, Marzia; Chiusolo, Patrizia; Fanin, Matteo; Mauro, Endri; Aprile, Lara; Mazzone, Carla; Trastulli, Fabio; Ciccone, Maria; De Gobbi, Marco; Cignetti, Alessandro; De Bellis, Eleonora; Mancini, Valentina; Piciocchi, Alfonso; Vignetti, Marco; Marsili, Giovanni; Starza, Irene Della; Fanin, Renato; Luppi, Mario; Ferrara, Felicetto; Pizzolo, Giovanni; Bassan, Renato; Foa, Robin; Candoni, Anna. - In: HAEMATOLOGICA. - ISSN 1592-8721. - (2024), pp. 1-35. [10.3324/haematol.2024.285638]

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

Luppi, Mario;CANDONI, ANNA
2024

Abstract

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.
2024
1
35
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 / Lazzarotto, Davide; Cerrano, Marco; Papayannidis, Cristina; Chiaretti, Sabina; Mosna, Federico; Fracchiolla, Nicola; Zappasodi, Patrizia; Imbergamo, Silvia; Del Principe, Maria Ilaria; Lunghi, Monia; Lussana, Federico; Piccini, Matteo; Fumagalli, Monica; Dargenio, Michelina; Salutari, Prassede; Forghieri, Fabio; Da Molin, Teresa Giulia; Bonifacio, Massimiliano; Olivi, Matteo; Giglio, Fabio; Trappolini, Silvia; Leoncin, Matteo; Mule, Antonino; Delia, Mario; Pasciolla, Crescenza; Grimaldi, Francesco; Cambo, Benedetta; Santoro, Lidia; Guolo, Fabio; Minetto, Paola; Defina, Marzia; Chiusolo, Patrizia; Fanin, Matteo; Mauro, Endri; Aprile, Lara; Mazzone, Carla; Trastulli, Fabio; Ciccone, Maria; De Gobbi, Marco; Cignetti, Alessandro; De Bellis, Eleonora; Mancini, Valentina; Piciocchi, Alfonso; Vignetti, Marco; Marsili, Giovanni; Starza, Irene Della; Fanin, Renato; Luppi, Mario; Ferrara, Felicetto; Pizzolo, Giovanni; Bassan, Renato; Foa, Robin; Candoni, Anna. - In: HAEMATOLOGICA. - ISSN 1592-8721. - (2024), pp. 1-35. [10.3324/haematol.2024.285638]
Lazzarotto, Davide; Cerrano, Marco; Papayannidis, Cristina; Chiaretti, Sabina; Mosna, Federico; Fracchiolla, Nicola; Zappasodi, Patrizia; Imbergamo, S...espandi
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