Treatment of standard-risk acute lymphoblastic leukemia in children: The results of protocol AL841 from the Kyushu-Yamaguchi Children's Cancer Study Group in Japan

A total of 62 patients with standard-risk nc acute lymphoblastic leukemia r ecieved three-drug induction consisting of vincristine, prednisolone and L- asparaginase (l-Asp) followed by consolidation therapy with intermediate-do se methotrexate (MTX), intrathecal MTX, and 18 Gy of cranial irradiation. M aintenance therapy consisting of 6 drugs including daunorbicin (DNR 450 mg/ m(2) in total) was continued for 3 years. Patients tome randomized and half of them received weekly I-Asl, during maintenance therapy as a late intens ification. Complete remission (CR) was achieved in 61/62 (98.4%), and II of 61 patients relapsed. At 10 years, the event-free survival (EFS) was 80.6 +/- 5.0% and overall survival was 88.7 +/- 4.0%; median follow-up, time was 9.3 years. The 10-year EFS of Patients with additional l-Asp (84.8 +/- 6.2 %) was superior to that without l-Asp, (75.9 +/- 7.9%), although if was no t statistically significant. No patients wire received a full dose of DNR a nd maintained CR dpc,eloped heart failure, although the shortening fraction decreased from 41.0% at diagnosis to 35.2% (median). The Protocol AL841 pr ovided good long-term disease control without severe late cardiac dysfuncti on.