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CAMPUS-ALL subgroup analysis: Polyethylene glycolated-pegaspargase in older patients with Ph-negative ALL
The prognosis of Philadelphia-negative (Ph-negative) acute lymphoblastic leukemia (ALL) has improved in adults with the adoption of pediatric-inspired asparaginase regimens. However, higher rates of asparaginase-related adverse events in older adults make its use more challenging in this population. Polyethylene glycolated-asparaginase (PEG-ASP) has shown a reduced toxicity profile. Lazzarotto et al. published a subgroup analysis from the real-world CAMPUS-ALL study evaluating the feasibility and tolerability of PEG-ASP in patients with newly diagnosed Ph-negative ALL or lymphoblastic lymphoma in the Annals of Hematology. The subgroup analysis included patients aged ≥55 years who were treated based on the GIMEMA LAL1913 protocol and received an age-adjusted dose of PEG-ASP 1000 IU/m2 (n = 90). Efficacy outcomes included complete remission rate, measurable residual disease, overall survival, and disease-free survival. Treatment-related toxicity was assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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Key learnings |
Hepatic toxicity was the most frequently reported AE; 38% of patients experienced any grade HT at C1 (Grade ≥3, 19%) and 23% at C2 (Grade ≥3, 9%). Coagulopathy occurred in 26% of patients at C1 and 20% of patients at C2. |
The CR and MRD negativity rates were 94% (73/77) and 40% (29/73) at C1 and 93% (53/57) and 68% (36/53) at C3. PEG-ASP dose was associated with a higher MRD negativity rate at TP2 (OR, 5.290; 95% CI, 1.32–21.20; p = 0.02). |
The 3-year OS and DFS estimates for patients who received ≥1 dose of PEG-ASP were 54% and 47%, respectively. MRD negativity at TP2 was associated with improved DFS (HR, 0.181; 95% CI, 0.057–0.568; p = 0.003). |
PEG-ASP administration was feasible in older adults; however, hepatic toxicity remains a major cause of PEG-ASP interruption. PEG-ASP dose should be adjusted based on age and comorbidities to optimize the efficacy/toxicity balance. |
AE, adverse event; ALL, acute lymphoblastic leukemia; C, cycle; CI, confidence interval; CR, complete remission; DFS, disease-free survival; HR, hazard ratio; HT, hepatic toxicity; MRD, measurable residual disease; OR, odds ratio; OS, overall survival; PEG-ASP, polyethylene glycolated-asparaginase; Ph-negative, Philadelphia-negative; TP2, timepoint 2.
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