Document Detail

A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis.
MedLine Citation:
PMID:  11342423     Owner:  NLM     Status:  MEDLINE    
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 (AUC(0-96)). Fifty-two patients were randomized at 6 sites. In an intent-to-treat analysis, the mean uric acid AUC(0-96) 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.
S C Goldman; J S Holcenberg; J Z Finklestein; R Hutchinson; S Kreissman; F L Johnson; C Tou; E Harvey; E Morris; M S Cairo
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Blood     Volume:  97     ISSN:  0006-4971     ISO Abbreviation:  Blood     Publication Date:  2001 May 
Date Detail:
Created Date:  2001-05-08     Completed Date:  2001-06-14     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7603509     Medline TA:  Blood     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2998-3003     Citation Subset:  AIM; IM    
Department of Pediatric Hematology/Oncology at North Texas Hospital for Children at Medical City, Dallas, TX, USA.
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MeSH Terms
Allopurinol / administration & dosage,  adverse effects,  therapeutic use*
Child, Preschool
Creatinine / blood
Drugs, Investigational
Kidney / physiopathology
Kidney Failure / etiology
Leukemia / complications*,  drug therapy,  physiopathology
Lymphoma / complications*,  drug therapy,  physiopathology
Recombinant Proteins / administration & dosage,  adverse effects,  therapeutic use
Risk Factors
Treatment Outcome
Tumor Lysis Syndrome / prevention & control*
Urate Oxidase / administration & dosage,  adverse effects,  metabolism,  therapeutic use*
Uric Acid / blood*
Reg. No./Substance:
0/Drugs, Investigational; 0/Recombinant Proteins; 315-30-0/Allopurinol; 60-27-5/Creatinine; 69-93-2/Uric Acid; EC Oxidase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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