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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

From the Tokyo Children's Cancer Study Group; Departments of Hematology and Epidemiology, National Center for Child Health and Development; Department of Pediatrics, St Luke's International Hospital; First Department of Pediatrics, Toho University; Department of Pediatrics, Tokyo Medical and Dental University, School of Medicine; Department of Pediatrics, Nippon Medical School, Tokyo; Department of Pediatrics, Japanese Red Cross Narita Hospital, Narita; Department of Hematology-Oncology, Chiba Children's Hospital, Chiba; Department of Pediatrics, University of Shinshu, School of Medicine, Matsumoto; Department of Pediatrics, Showa University, School of Medicine, Fujigaoka Hospital; Department of Pediatrics, Yokohama City University, School of Medicine, Yokohama; Department of Pediatrics, Japanese Red Cross Maebashi Hospital, Maebashi; Department of Pediatrics, Dokkyo University School of Medicine, Utsunomiya; Department of Pediatrics, Yamanashi University, School of Medicine, Kofu; Department of Pediatrics, Tokai University, School of Medicine, Isehara; Department of Pediatrics, St Marianna University School of Medicine, Kawasaki; Department of Hematology-Oncology, Tokyo Metropolitan Kiyose Children's Hospital, Kiyose; Department of Hematology-Oncology, Gunma Children's Medical Center, Seta; Department of Hematology-Oncology, Saitama Children's Medical Center, Iwatsuki; and Department of Pediatrics, Ibaraki Children's Hospital, Mito, Japan

Address reprint requests to Shunji Igarashi, MD, Department of Pediatrics, Japanese Red Cross Narita Hospital, 90-1, Iidacho, Narita, 286-8523, Japan; e-mail: shun2{at}cd5.so-net.ne.jp

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).

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.

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.

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.

Supported in part by a grant from the Children's Cancer Association of Japan.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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