TITLE:
Dexamethasone versus Prednisone in Childhood Acute Lymphoblastic Leukemia Treatment: Results of the Indonesian Randomized Trial
AUTHORS:
Pudjo H. Widjajanto, Eddy Supriyadi, Ignatius Purwanto, Jacqueline Cloos, Peter M. vdVen, Sutaryo , Anjo JP. Veerman
KEYWORDS:
Dexamethasone versus Prednisone, Childhood ALL, Indonesia
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.8 No.8,
August
3,
2017
ABSTRACT:
Background: Randomized trials report that, compared to prednisone, dexamethasone
has reduced CNS relapse and improved event-free survival (EFS),
despite a trend toward a higher risk for induction death. Because toxic death
is a specific problem in the Indonesian setting, this study compares the outcome
of dexamethasone versus prednisone. Methods: In the period 2006 -
2011, 196 patients with childhood acute lymphoblastic leukemia (ALL) treated
on the Indonesia-ALL-2006 protocol [first standard risk (SR) and later high
risk (HR) patients] were randomized to receive dexamethasone or prednisone
as steroid. Patients in the dexamethasone arm (n = 102: 68 SR, 34 HR) received
dexamethasone 4 mg/m2/day (SR) or 6 mg/m2/day (HR), while the
prednisone arm (n = 94: 66 SR, 28 HR) received prednisone 40 mg/m2/day
(SR and HR). Results: Patients in the dexamethasone arm showed no significant
difference compared to the prednisone arm in abandonment rate (24.5%
vs. 25.5%, P = 0.91), death rate (17.7% vs. 14.9%, P = 0.54), or leukemic events
(13.7 vs. 11.7%, P = 0.59). After stratification for risk group, a trend towards a
higher death rate was found in the dexamethasone arm of SR patients (16.2 vs.
6.1%, P = 0.06). The 3-year survival for EFS in SR and HR patients for dexamethasone
versus prednisone was 31.5% ± 6.6% vs. 41.5% ± 5.9% (P = 0.51),
for leukemia-free survival (LFS) it was 63.7% ± 9.3% vs. 74.5% ± 7.6% (P =
0.47), and for overall survival (OS) it was 49.5% ± 7.7% vs. 69.3% ± 6.1% (P =
0.09). Conclusions: In our setting, a trend toward higher induction deaths was observed in the dexamethasone arm of SR patients and the 3-year EFS;
LFS and OS rates were lower in the dexamethasone group; however, these differences
were not significant.