Treatment of childhood acute lymphoblastic leukemia: results of Dana-Farber Cancer Institute/Children's Hospital Acute Lymphoblastic Leukemia Consortium Protocol 85-01.

PURPOSE: The goals of this treatment program were as follows: to improve event-free survival (EFS) rates for high-risk (HR) patients by increasing the intensity of induction treatment; to improve EFS rates for infants by adding a special postinduction intensification; to treat the CNS using cranial irradiation doses that were lower than in our historic control group; and to confirm our previously obtained good results for children with T-cell disease. PATIENTS AND METHODS: Two hundred twenty children with acute lymphoblastic leukemia (ALL) from all risk groups, including infants and patients with T-cell disease, were treated between 1985 and 1987 with multiagent chemotherapy and cranial irradiation. RESULTS: The 7-year EFS rate (+/- SE) for all 220 patients was 78% +/- 3% at a median follow-up duration of 6.2 years, 89% +/- 4% for the 82 patients classified as standard risk (SR), and 72% +/- 4% for the remaining 138 patients classified as HR and very high risk (VHR). Eleven infants had an EFS rate of 55% +/- 15% that might be attributable to treatment with high doses of methotrexate and cytarabine (ara-c). Twenty children with T-cell disease had an EFS rate of 70% +/- 10%. CNS leukemia relapse (isolated or combined with bone marrow) occurred in four of 82 SR patients who received 18 Gy of cranial irradiation and four of 138 HR and VHR patients who received 24 Gy. CONCLUSION: This protocol, which featured early intensive treatment including asparaginase, doxorubicin, and cranial irradiation, provided good long-term disease control for children with ALL.