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Blood, 15 May 2001, Vol. 97, No. 10, pp. 2998-3003
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
A randomized comparison between rasburicase and allopurinol in
children with lymphoma or leukemia at high risk for tumor
lysis
Stanton C. Goldman,
John S. Holcenberg,
Jerry Z. Finklestein,
Raymond Hutchinson,
Susan Kreissman,
F. Leonard Johnson,
Conrad Tou,
Elizabeth Harvey,
Erin Morris, and
Mitchell S. Cairo
Standard therapy in the United States for malignancy-associated
hyperuricemia consists of hydration, alkalinization, and allopurinol. Urate oxidase catalyzes the enzymatic oxidation of uric acid to a 5 times increased urine soluble product, allantoin. Rasburicase is a new
recombinant form of urate oxidase available for clinical evaluation.
This multicenter randomized trial compared allopurinol to rasburicase
in pediatric patients with leukemia or lymphoma at high risk for tumor
lysis. Patients received the assigned uric acid-lowering agent for 5 to
7 days during induction chemotherapy. The primary efficacy end point
was to compare the area under the serial plasma uric acid concentration
curves during the first 96 hours of therapy (AUC0-96).
Fifty-two patients were randomized at 6 sites. In an intent-to-treat
analysis, the mean uric acid AUC0-96 was 128 ± 70
mg/dL.hour for the rasburicase group and 329 ± 129 mg/dL.hour for
the allopurinol group (P < .0001). The rasburicase versus allopurinol group experienced a 2.6-fold (95% CI:
2.0-3.4) less exposure to uric acid. Four hours after the first dose,
patients randomized to rasburicase compared to allopurinol achieved an
86% versus 12% reduction (P < .0001) of initial plasma uric acid levels. No antirasburicase antibodies were detected at day
14. This randomized study demonstrated more rapid control and lower
levels of plasma uric acid in patients at high risk for tumor lysis who
received rasburicase compared to allopurinol. For pediatric patients
with advanced stage lymphoma or high tumor burden leukemia, rasburicase
is a safe and effective alternative to allopurinol during initial chemotherapy.
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