A randomized trial of a single-dose rasburicase versus five-daily doses in patients at risk for tumor lysis syndrome.

Abstract

BACKGROUND:

Tumor lysis syndrome (TLS) is a life-threatening disorder characterized by hyperuricemia and metabolic derangements. The efficacy of rasburicase, administered daily for 5 days, has been well established. However, the optimal duration of therapy is unknown in adults.

PATIENTS AND METHODS:

We evaluated the efficacy of rasburicase (0.15 mg/kg) administered as single dose followed by as needed dosing (maximum five doses) versus daily dosing for 5 days in adult patients at risk for TLS.

RESULTS:

Eighty of the 82 patients enrolled received rasburicase; 40 high risk [median uric acid (UA) 8.5 mg/dl; range, 1.5-19.7] and 40 potential risk (UA = 5.6 mg/dl; range, 2.4-7.4). Seventy-nine patients (99%) experienced normalization in their UA within 4 h after the first dose; 84% to an undetectable level (<0.7 mg/dl). Thirty-nine of 40 (98%) patients in the daily-dose arm and 34 of 40 (85%) patients in single-dose arm showed sustained UA response. Six high-risk patients within the single-dose arm required second dose for UA >7.5 mg/dl. Rasburicase was well tolerated; one patient with glucose-6-phosphate dehydrogenase deficiency developed methemoglobinemia and hemolysis.

CONCLUSIONS:

Rasburicase is highly effective for prevention and management of hyperuricemia in adults at risk for TLS. Single-dose rasburicase was effective in most patients; only a subset of high-risk patients required a second dose.

• Authors: S Vadhan-Raj, L E Fayad, M A Fanale, B Pro, A Rodriguez, F B Hagemeister, C E Bueso-Ramos, X Zhou, P W McLaughlin, N Fowler, J Shah, R Z Orlowski, F Samaniego, M Wang, J E Cortes, A Younes, L W Kwak, N J Sarlis, J E Romaguera
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 23 Issue 6 Pg. 1640-5 (Jun 2012) ISSN: 1569-8041 [Electronic] England
• PMID: 22015451 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Gout Suppressants
• rasburicase
• Uric Acid
• Urate Oxidase

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (adverse effects, therapeutic use)
• Female
• Gout Suppressants (administration & dosage, therapeutic use)
• Humans
• Lymphoma, Large B-Cell, Diffuse (drug therapy)
• Male
• Middle Aged
• Risk Factors
• Treatment Outcome
• Tumor Lysis Syndrome (etiology, prevention & control)
• Urate Oxidase (administration & dosage, therapeutic use)
• Uric Acid (blood)