Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2026
Asperginase-based chemotherapy regimen for acute lymphoblastic leukemia: A cohort study with promising outcomes on adults.
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Oghab Padideh, Bakhshi Masoomeh, Pourpoune Mohadese, Motamedi Narges
Аннотация
BACKGROUND: Acute lymphoblastic leukemia (ALL) is a malignancy of lymphoid progenitor cells. Asparaginase-based regimens are highly effective in pediatric ALL, but concerns over toxicity have limited their use in adults. This study evaluates the incidence of adverse events following asparaginase treatment in the adult ALL population.
MATERIALS AND METHODS: In this retrospective cohort study, we assessed drug-related adverse events among 67 adults with ALL treated with either a hyper-central vascular access device (CVAD) (n = 34) or an asparaginase-containing regimen (n = 33). Those under asparaginase-containing treatment were evaluated solely and divided into two groups of pegylated asparaginase (PEG-asparaginase) (n = 21) and L-asparaginase (n = 12). We compared the incidence of hepatotoxicity, pancreatitis, hypertriglyceridemia, hypercholesterolemia, hyperglycemia, hypersensitivity, neurological disorders, and thrombotic events.
RESULTS: Age-adjusted analysis showed the risk of thrombosis was significantly higher in the asparaginase group compared to hyper-CVAD (odds ratio [OR] = 17.9, 95% confidence interval [CI]: 1.69-2512, P = 0.012). In contrast, risks of fungal infection (OR = 0.081, 95% CI: 0.0006-0.83, P = 0.032) and neutropenic fever (OR = 0.0006, 95% CI: 2.8e-17-0.010, P < 0.0001) were significantly lower. A sub-analysis revealed the elevated thrombosis risk was specific to PEG-asparaginase versus hyper-CVAD (OR = 47.05, 95% CI: 3.83-6905, P = 0.001), not L-asparaginase (P = 0.55). Neutropenic fever risk was lower for both L-asparaginase (OR = 0.0015, P < 0.0001) and PEG-asparaginase (OR = 0.0011, P < 0.0001).
CONCLUSION: Asparaginase use in adults with ALL was associated with fewer overall adverse events, specifically lower infection risks, compared to hyper-CVAD. However, it significantly increased the risk of thrombosis, an effect driven primarily by the PEG-asparaginase formulation. While L-asparaginase appeared more favorable, the small sample size limits generalizability. These findings indicate that asparaginase remains a viable option for adults, but requires vigilant monitoring and prophylaxis for thrombotic events.
MATERIALS AND METHODS: In this retrospective cohort study, we assessed drug-related adverse events among 67 adults with ALL treated with either a hyper-central vascular access device (CVAD) (n = 34) or an asparaginase-containing regimen (n = 33). Those under asparaginase-containing treatment were evaluated solely and divided into two groups of pegylated asparaginase (PEG-asparaginase) (n = 21) and L-asparaginase (n = 12). We compared the incidence of hepatotoxicity, pancreatitis, hypertriglyceridemia, hypercholesterolemia, hyperglycemia, hypersensitivity, neurological disorders, and thrombotic events.
RESULTS: Age-adjusted analysis showed the risk of thrombosis was significantly higher in the asparaginase group compared to hyper-CVAD (odds ratio [OR] = 17.9, 95% confidence interval [CI]: 1.69-2512, P = 0.012). In contrast, risks of fungal infection (OR = 0.081, 95% CI: 0.0006-0.83, P = 0.032) and neutropenic fever (OR = 0.0006, 95% CI: 2.8e-17-0.010, P < 0.0001) were significantly lower. A sub-analysis revealed the elevated thrombosis risk was specific to PEG-asparaginase versus hyper-CVAD (OR = 47.05, 95% CI: 3.83-6905, P = 0.001), not L-asparaginase (P = 0.55). Neutropenic fever risk was lower for both L-asparaginase (OR = 0.0015, P < 0.0001) and PEG-asparaginase (OR = 0.0011, P < 0.0001).
CONCLUSION: Asparaginase use in adults with ALL was associated with fewer overall adverse events, specifically lower infection risks, compared to hyper-CVAD. However, it significantly increased the risk of thrombosis, an effect driven primarily by the PEG-asparaginase formulation. While L-asparaginase appeared more favorable, the small sample size limits generalizability. These findings indicate that asparaginase remains a viable option for adults, but requires vigilant monitoring and prophylaxis for thrombotic events.