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

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.

• Authors: Shunji Igarashi, Atsushi Manabe, Akira Ohara, Masaaki Kumagai, Tomohiro Saito, Yuri Okimoto, Takehiko Kamijo, Keiichi Isoyama, Michiko Kajiwara, Manabu Sotomatsu, Ken-ichi Sugita, Kanji Sugita, Miho Maeda, Hiromasa Yabe, Akitoshi Kinoshita, Takashi Kaneko, Yasuhide Hayashi, Kouichiro Ikuta, Ryohji Hanada, Masahiro Tsuchida
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 23 Issue 27 Pg. 6489-98 (Sep 20 2005) ISSN: 0732-183X [Print] United States
• PMID: 16170158 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dexamethasone
• Prednisolone

Topics

• Child
• Child, Preschool
• Dexamethasone (administration & dosage)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Japan
• Male
• Precursor Cell Lymphoblastic Leukemia-Lymphoma (diagnosis, drug therapy, mortality)
• Prednisolone (administration & dosage)
• Probability
• Prospective Studies
• Recurrence
• Reference Values
• Risk Assessment
• Sensitivity and Specificity
• Severity of Illness Index
• Treatment Outcome