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No advantage of dexamethasone over prednisolone for the outcome of standard- and intermediate-risk childhood acute lymphoblastic leukemia in the Tokyo Children's Cancer Study Group L95-14 protocol.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2005 Sep 20; Vol. 23 (27), pp. 6489-98. - Publication Year :
- 2005
-
Abstract
- Purpose: To evaluate whether dexamethasone (DEXA) yields a better outcome than prednisolone (PRED) in a prospective, randomized, controlled trial for the treatment of childhood acute lymphoblastic leukemia (ALL).<br />Patients and Methods: Two hundred thirty-one standard-risk (SR) patients and 128 intermediate-risk (IR) non-B-cell ALL patients were registered from March 1995 to March 1999. After random assignment in each group, the PRED arm patients received PRED 60 mg/m2 during induction followed by PRED 40 mg/m2 over four intensifications in the SR group and three intensifications in the IR group. DEXA arm patients received DEXA 8 mg/m2 during induction and DEXA 6 mg/m2 during the intensifications. The maintenance phase was continued until week 104.<br />Results: Event-free survival rates at 8 years in the DEXA and PRED arms were 81.1% +/- 3.9% (n = 117) and 84.4% +/- 5.2% (n = 114), respectively, in the SR group (P = .217) and 84.9% +/- 4.6% (n = 62) and 80.4% +/- 5.1% (n = 66), respectively, in the IR group (P = .625). The primary reason for treatment failure was marrow relapse. Only two extramedullary relapses occurred in the DEXA arm compared with seven relapses in the PRED arm. Although complications were more prevalent in the DEXA arm than in the PRED arm, fatal toxicity was rare both groups.<br />Conclusion: DEXA administered at 8 mg/m2 during induction and 6 mg/m2 during intensification showed no advantage over PRED administered at 60 mg/m2 during induction and 40 mg/m2 during intensification in both the SR and IR groups.
- Subjects :
- Child
Child, Preschool
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Japan
Male
Precursor Cell Lymphoblastic Leukemia-Lymphoma mortality
Probability
Prospective Studies
Recurrence
Reference Values
Risk Assessment
Sensitivity and Specificity
Severity of Illness Index
Treatment Outcome
Dexamethasone administration & dosage
Precursor Cell Lymphoblastic Leukemia-Lymphoma diagnosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy
Prednisolone administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 23
- Issue :
- 27
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 16170158
- Full Text :
- https://doi.org/10.1200/JCO.2005.01.982