ADVERTISEMENT
Pegaspargase-Modified Risk-Oriented Regimen for Patients With Philadelphia Chromosome–Negative ALL
Results of the GIMEMA LAL1913 Trial
Results of the GIMEMA LAL1913 Trial
According to results from the GIMEMA LAL 1913 trial, the addition of a pegaspargase-modified minimal residual disease (MRD) risk-oriented program improved outcomes of patients with Philadelphia chromosome–negative acute lymphoblastic leukemia/lymphoma (Ph– ALL/LL) aged up to 65 years.
In a multicenter national setting, study investigators added pegaspargase 2000 IU/m2 to courses 1, 2, 5, and 6 of an 8-block protocol for patients aged from 18 to 65 years, with dose reductions among patients aged >55 years. Responders were risk-stratified for allogeneic hematopoietic cell transplantation (HCT) or maintenance per clinical characteristics and MRD.
Of the 203 eligible patients, 91% achieved a complete remission. The 3-year overall survival (OS), event-free survival (EFS), and disease-free survival (DFS) rates were 66.7%, 57.7%, and 63.3%, respectively, which fulfilled the primary study end point of a 2-year DFS >55%.
Disease-free survival measured 74% in the chemotherapy cohort and 50% in the HCT cohort, which determined that a time-dependent analysis proved the value of HCT in patients who were eligible (DFS HCT 70% vs no HCT 26%; P < .0001). In the multivariate analysis, age and MRD were independent factors that predicted DFS rates of 86% (age ≤ 40 and MRD-negative), 64%-65% (MRD-positive or age > 40) and 25% (age > 40 and MRD-positive); P < .0001. Grade ≥2 pegaspargase toxicity was mainly observed during course 1, which contributed to induction death in 2 patients.
The study authors concluded, “This program improved outcomes of patients with Ph– ALL/LL aged up to 65 years in a multicenter national setting.”
Source:
Bassan R, Chiaretti S, Starza I, et al. Pegaspargase-modified risk-oriented program for adult acute lymphoblastic leukemia: Results of the GIMEMA LAL1913 trial. Blood Adv. Published online August 11, 2023. doi: doi.org/10.1182/bloodadvances.2022009596
