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

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.

Dexamethasone versus prednisone for induction therapy in childhood acute lymphoblastic leukemia: a systematic review and meta-analysis

“…The primary outcome measures were (1) event rate; event was defined as death from any cause, refractory or relapsed leukemia, or second malignancy; 7,8,14 (2) relapse rate, specifically: (a) any CNS-relapse (if not reported as such, isolated CNS relapse (first choice) or extramedullary relapse (second choice) were analyzed), (b) isolated bone marrow relapse (if not reported as such, non-CNS relapse was analyzed), (c) isolated testicular relapse or (d) combined relapse (any combination of CNS, bone marrow or testicular relapse); and (3) mortality rate. The observation time point was defined by each study differently but varied between 5 and 8 years.…”

“…Of these, eight studies satisfied eligibility criteria and were included in the metaanalysis. [6][7][8][9][14][15][16]22 The reviewers had perfect agreement on articles for inclusion, with a k statistic of 1.0. The reasons for excluding 15 articles are shown in Figure 1.…”

“…7,9 Blinding status was not reported by any study. Withdrawal information could be retrieved from four of the eight, [6][7][8]22 and intention-to-treat analysis was reported for three trials 6,8,14,16 (Supplementary Data B).…”

“…Qualitatively, there appeared to be superiority for DEX in studies with PRED/DEX dose ratios o7 and superiority for PRED in studies using ratios X7 (both non-significant; Table 2 and Supplementary Data C). No significant difference between DEX and PRED was identified in terms of overall mortality (three studies) 6,7,22 or testicular relapse (two studies) 6,8 ( Table 2). Only one study provided data regarding combined relapse.…”

“…In contrast, a Japanese study (TCCSG L95-14) did not confirm the advantage of using DEX when PRED was used at a higher dose. 8 It is difficult to compare the current evidence in the literature because of substantial differences between trials in terms of study design. First, different relative doses of PRED and DEX were used in those trials.…”