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

Ann Oncol. 2012 Jun;23(6):1640-5. doi: 10.1093/annonc/mdr490. Epub 2011 Oct 19.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

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