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

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

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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.

Original languageEnglish (US)
Pages (from-to)1640-1645
Number of pages6
JournalAnnals of Oncology
Volume23
Issue number6
DOIs
StatePublished - Jun 6 2012

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Keywords

  • Hematologic malignancy
  • Hyperuricemia
  • Rasburicase
  • Tumor lysis syndrome

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Vadhan-raj, S., Fayad, L. E., Fanale, M. A., Pro, B., Rodriguez, A., Hagemeister, F. B., Bueso-ramos, C. E., Zhou, X., Mclaughlin, P. W., Fowler, N., Shah, J., Orlowski, R. Z., Samaniego, F., Wang, M., Cortes, J. E., Younes, A., Kwak, L. W., Sarlis, N. J., & Romaguera, J. E. (2012). A randomized trial of a single-dose rasburicase versus five-daily doses in patients at risk for tumor lysis syndrome. Annals of Oncology, 23(6), 1640-1645. https://doi.org/10.1093/annonc/mdr490