L-Asparaginase: Long-Term Results of a Randomized Trial of the Effect of Additional 3 Doses During Consolidation Treatment in the Indonesian WK-ALL-2000 Protocol

We conducted a randomized trial to compare the influence of 3 additional doses of L-asparaginase on clinical outcome of newly diagnosed childhood acute lymphoblastic leukemia (ALL). Patients were treated using Indonesian WK-ALL-2000 protocol between 1999 and 2005 and randomized to receive (3A arm, n=61) or not to receive (0A arm, n=56) an additional 3 weekly doses of 6000 IU/m2/dose of Escherichia coli L-asparaginase during consolidation treatment on top of 2 doses (standard-risk patients) or 5 doses (high-risk patients). Events after remission included relapse (37.6%), death (16.2%), and abandonment of therapy (15.4%). There was no significant difference in relapses between the 2 arms. Patients in arm 3A versus 0A tended to have a lower 5 years disease-free survival (47.4±7.9% vs. 51.7±7.9%, P=0.72) and lower 5 years event-free survival (29.5±5.8% vs. 35.7±6.4%, P=0.61). We conclude that in our setting the use of 3 additional doses of L-asparaginase during consolidation therapy did not result in survival advantage. Contrariwise, adverse effects from this drug included higher treatment cost and systemic toxicity.