title: Benefit of high-dose methylprednisolone in comparison with conventional-dose prednisolone during remission induction therapy in childhood acute lymphoblastic leukemia for long-term follow-up.
abstract: Eight-year event-free survival (EFS) was evaluated in 205 patients with acute lymphoblastic leukemia (ALL), to consider the efficacy of high-dose methylprednisolone (HDMP) given during remission induction chemotherapy between 1 and 29 days. The St Jude Total XI Study protocol was used after some minor modifications in this trial. Patients were randomized into two groups. Group A (n = 108) received conventional dose (60 mg/m(2)/day orally) prednisolone and group B (n = 97) received HDMP (Prednol-L, 900-600 mg/m(2) orally) during remission induction chemotherapy. Complete remission was obtained in 95% of the 205 patients who were followed-up for 11 years; median follow-up was 72 months (range 60-129) and 8-year EFS rate was 60% overall (53% in group A, 66% in group B). The EFS rate of group B was significantly higher than of group A (P = 0.05). The 8-year EFS rate of groups A and B in the high-risk groups was 39% vs 63% (P = 0.002). When we compared 8-year EFS rate in groups A and B in the high-risk subgroup for both ages together </=2 or >/=10 years, it was 44% vs 74%, respectively. Among patients in the high-risk subgroup with a WBC count >/=50 x 10(9)/l, the 8-year EFS was 38% in group A vs58% in group B. During the 11-year follow-up period, a total of 64 relapses occurred in 205 patients. In group A relapses were higher (39%) than in group B (23%) (P = 0.05). These results suggest that HDMP during remission-induction chemotherapy improves the EFS rate significantly for high-risk patients in terms of the chances of cure.
authors.affiliation: Department of Pediatric Hematology, Hacettepe University, Ihsan Dogramaci Children's Hospital, Ankara, Turkey.
authors.forename: S
authors.initials: S
authors.lastname: Yetgin
authors.forename: M A
authors.initials: MA
authors.lastname: Tuncer
authors.forename: M
authors.initials: M
authors.lastname: Cetin
authors.forename: F
authors.initials: F
authors.lastname: Gümrük
authors.forename: I
authors.initials: I
authors.lastname: Yenicesu
authors.forename: B
authors.initials: B
authors.lastname: Tunç
authors.forename: A F
authors.initials: AF
authors.lastname: Oner
authors.forename: H
authors.initials: H
authors.lastname: Toksoy
authors.forename: A
authors.initials: A
authors.lastname: Koç
authors.forename: D
authors.initials: D
authors.lastname: Aslan
authors.forename: E
authors.initials: E
authors.lastname: Ozyürek
authors.forename: L
authors.initials: L
authors.lastname: Olcay
authors.forename: L
authors.initials: L
authors.lastname: Atahan
authors.forename: E
authors.initials: E
authors.lastname: Tunçbilek
authors.forename: A
authors.initials: A
authors.lastname: Gürgey
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality; D011239:Prednisolone / Q000627:therapeutic use*; D012074:Remission Induction / Q000379:methods; D012189:Retrospective Studies; D015996:Survival Rate; D013997:Time Factors
chemical_list: D011239:Prednisolone; D008775:Methylprednisolone