title: 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.
abstract: OBJECTIVE
  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).
  
  
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Tokyo Children's Cancer Study Group, Department of Hematology and Epidemiology, National Center for Child Health and Development, Japan. shun2@cd5.so-net.ne.jp
authors.forename: Shunji
authors.initials: S
authors.lastname: Igarashi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Manabe
authors.forename: Akira
authors.initials: A
authors.lastname: Ohara
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kumagai
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Saito
authors.forename: Yuri
authors.initials: Y
authors.lastname: Okimoto
authors.forename: Takehiko
authors.initials: T
authors.lastname: Kamijo
authors.forename: Keiichi
authors.initials: K
authors.lastname: Isoyama
authors.forename: Michiko
authors.initials: M
authors.lastname: Kajiwara
authors.forename: Manabu
authors.initials: M
authors.lastname: Sotomatsu
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Sugita
authors.forename: Kanji
authors.initials: K
authors.lastname: Sugita
authors.forename: Miho
authors.initials: M
authors.lastname: Maeda
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Yabe
authors.forename: Akitoshi
authors.initials: A
authors.lastname: Kinoshita
authors.forename: Takashi
authors.initials: T
authors.lastname: Kaneko
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Hayashi
authors.forename: Kouichiro
authors.initials: K
authors.lastname: Ikuta
authors.forename: Ryohji
authors.initials: R
authors.lastname: Hanada
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuchida
mesh_terms: D002648:Child; D002675:Child, Preschool; D003907:Dexamethasone / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D011239:Prednisolone / Q000008:administration & dosage*; D011336:Probability; D011446:Prospective Studies; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003907:Dexamethasone; D011239:Prednisolone