[Long-term results of intermittent massive therapy (protocol HIM-T.M.I.) in children with acute lymphoblastic...

Long-term results of treatment of 45 children with acute lymphoblastic leukemia are reported. The maintenance therapy of remission was biweekly MITX in a Control Group (20 patients) and combination of monthly therapy (T.M.I.) oral MTX, 6MP and CP, at very high doses and reinduction with Pred and VCR, every 6 weeks in the Study Group (25 patients). The median duration of remission was 10 and 26 months, respectively. Six patients of the Study Group are still in their first complete hemission for 57 to 95 months (median of 75). CNS leukemic was the initial site of relapse in 55 and 56% of the groups, respectively, but in the Central Group it took place at 10 month and in the Study Group of median of 22.5 months after remission was achieved. In 16 patients of both groups, TMT prolonged the second remission 5.5 to 7.5 months. The median duration of survival was 17 months (Control Group) and 46 months (Study Group). The difference was due to longer hematologic remissions in the second group. Up to Feburary, 1976, all patients of the Control Group have died and 7 children of the Study Group are alive, one for 76 months but has had several relapses and 6 patients (24%) without evidence of disease from 56 to 96 months after diagnosis (median 77 months) and all are now out of antileukemic treatment from 18 to 48 months (median 31 months). These 6 patients are considered probably cured. Toxicity was more severe in the Study Group but never threatened the patient's life.