A COMPARISON OF THE EFFECT OF HIGH-DOSE METHYLPREDNISOLONE WITH CONVENTIONAL-DOSE PREDNISOLONE IN ACUTE LYMPHOBLASTIC-LEUKEMIA PATIENTS WITH RANDOMIZATION

In this preliminary study the efficacy of high-dose methylprednisolone (HDMP) during remission-induction chemotherapy was evaluated on 166 c hildren with acute lymphoblastic leukemia (ALL). The St. Jude Total Th erapy Study XI protocol with minor modifications was used in this tria l. Patients were randomized into two groups. Group A received conventi onal-dose (2 mg/kg/day orally) prednisolone, and group B received high -dose methylprednisolone (HDMP, Prednol-L, 900-600 mg/m(2) orally) dur ing remission-induction chemotherapy. Complete remission was achieved in 97% of the children. For the 80 patients who were followed up for 3 years, median follow-up was 44 (range 5-60) months and the 3-year eve nt-free survival (EFS) rate was 68.5% overall, 58.6% in group A and 78 .4% in group B. The EFS among patients in group B was significantly hi gher than in group A (p = 0.05). When we compared the 3-year EFS of gr oups A and B in the high-risk groups and high-risk subgroups with whit e blood cell (WBC) counts greater than or equal to 50 x 10(9)/l and ag e greater than or equal to 10 years, the survival rates were 45% versu s 77.2%, 33% versus 78% and 45% versus 89%, respectively. During the f ollow-up of 162 patients, relapses were significantly higher in group A. Bone marrow relapses in 162 patients, and also in a subgroup of pat ients 2 10 years of age were significantly higher in group A. These re sults suggest that HDMP during remission-induction chemotherapy improv es long-term EFS, particularly for high-risk patients. (C) 1998 Elsevi er Science Ltd. All rights reserved.