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Prepublished online as a Blood First Edition Paper on January 16, 2003; DOI 10.1182/blood-2002-08-2454.
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Blood, 15 May 2003, Vol. 101, No. 10, pp. 3809-3817
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Dexamethasone versus prednisone and daily oral versus weekly
intravenous mercaptopurine for patients with standard-risk acute
lymphoblastic leukemia: a report from the Children's Cancer
Group
Bruce C. Bostrom,
Martha R. Sensel,
Harland N. Sather,
Paul S. Gaynon,
Mei K. La,
Katherine Johnston,
Gary R. Erdmann,
Stuart Gold,
Nyla A. Heerema,
Raymond J. Hutchinson,
Arthur J. Provisor, and
Michael E. Trigg
From the Pediatric Oncology, Children's
Hospitals and Clinics, Minneapolis, MN; the Department of Preventive
Medicine, Keck School of Medicine, University of Southern California,
Los Angeles, CA; the Children's Oncology Group, Arcadia, CA; Childrens
Hospital Los Angeles, Los Angeles, CA; Childrens Hospital of Columbus,
Columbus, OH; PRACS Institute, Ltd, Fargo, ND; University of
North Carolina, Chapel Hill, NC; C. S. Mott Children's Hospital,
Ann Arbor, MI; Columbus Regional Medical Center, Columbus, GA; and
Christiana Care Health Services, Wilmington, DE.
Conventional therapy for childhood acute
lymphoblastic leukemia (ALL) includes prednisone and oral
6-mercaptopurine. Prior observations suggested potential advantages for
dexamethasone over prednisone and for intravenous (IV) over oral
6-mercaptopurine, which remain to be validated. We report the results
of a randomized trial of more than 1000 subjects that examined the
efficacy of dexamethasone and IV 6-mercaptopurine. Children with
National Cancer Institute standard-risk ALL were randomly assigned in a 2 × 2 factorial design to receive dexamethasone (6 mg/m2/d) for 28 days in induction, plus taper, compared
with prednisone (40 mg/m2/d). The second randomized
assignment was for daily oral or weekly IV 6-mercaptopurine during
consolidation. During maintenance, 5 days of the randomized steroid was
given monthly, at the same dose, and all patients received daily oral
6-mercaptopurine. During delayed intensification, all patients received
a dexamethasone dosage of 10 mg/m2/d for 21 days, with
taper. Intrathecal (IT) methotrexate was the sole central nervous
system-directed therapy. Patients randomly assigned to receive
dexamethasone had a 6-year isolated central nervous system-relapse
rate of 3.7% ± 0.8%, compared with 7.1% ± 1.1% for prednisone
(P = .01). There was also a trend toward fewer isolated
bone marrow relapses with dexamethasone. The 6-year event-free survival
(EFS) was 85% ± 2% for dexamethasone and 77% ± 2% for
prednisone (P = .002). EFS was similar with oral or IV 6-mercaptopurine; however, patients assigned to IV 6-mercaptopurine had
decreased survival after relapse.
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