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.
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.
Igarashi
Shunji
S
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
Manabe
Atsushi
A
Ohara
Akira
A
Kumagai
Masaaki
M
Saito
Tomohiro
T
Okimoto
Yuri
Y
Kamijo
Takehiko
T
Isoyama
Keiichi
K
Kajiwara
Michiko
M
Sotomatsu
Manabu
M
Sugita
Ken-ichi
K
Sugita
Kanji
K
Maeda
Miho
M
Yabe
Hiromasa
H
Kinoshita
Akitoshi
A
Kaneko
Takashi
T
Hayashi
Yasuhide
Y
Ikuta
Kouichiro
K
Hanada
Ryohji
R
Tsuchida
Masahiro
M
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
D003907:Dexamethasone; D011239:Prednisolone