A study of rasburicase for the management of hyperuricemia in pediatric patients with newly diagnosed hematologic malignancies at high risk for tumor lysis syndrome.

Tumor lysis syndrome (TLS), including hyperuricemia, is a frequent serious complication in patients with hematologic malignancies. This study in Japanese patients evaluated the efficacy, safety, and pharmacokinetic profile of rasburicase in pediatric patients with hematologic malignancies. Patients aged <18 years at high risk for TLS, with newly diagnosed hematologic malignancies, were randomized to intravenous rasburicase 0.15 mg/kg/day (n = 15) or 0.20 mg/kg/day (n = 15) for 5 days. Chemotherapy was started 4-24 h after the first rasburicase dose. Response was defined as a reduction in plasma uric acid to < or = 6.5 mg/dL (patients <13 years) or < or = 7.5 mg/dL (patients > or = 13 years) by 48 h after the first administration, lasting until 24 h after the final administration. Response rates were 93.3 and 100% with rasburicase 0.15 and 0.20 mg/kg/day, respectively. Uric acid levels declined rapidly within 4 h of starting rasburicase administration in both groups. Most adverse events were related to the underlying chemotherapy regimens. Two hypersensitivity reactions, including grade 1/2 pruritus, were considered to be related to rasburicase. Rasburicase is effective and well tolerated for the management of hyperuricemia in Japanese pediatric patients at high risk of developing TLS.
AuthorsAkira Kikuchi, Hisato Kigasawa, Masahito Tsurusawa, Keisei Kawa, Atsushi Kikuta, Masahiro Tsuchida, Yoshihisa Nagatoshi, Keiko Asami, Keizo Horibe, Atsushi Makimoto, Ichiro Tsukimoto
JournalInternational journal of hematology (Int J Hematol) Vol. 90 Issue 4 Pg. 492-500 (Nov 2009) ISSN: 1865-3774 [Electronic] Japan
PMID19701676 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Recombinant Proteins
  • rasburicase
  • Uric Acid
  • Urate Oxidase
  • Adolescent
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Child
  • Child, Preschool
  • Drug Hypersensitivity (complications)
  • Female
  • Hematologic Neoplasms (complications, drug therapy)
  • Humans
  • Hyperuricemia (drug therapy, etiology)
  • Infant
  • Male
  • Recombinant Proteins (adverse effects, blood, pharmacokinetics, therapeutic use)
  • Risk Factors
  • Treatment Outcome
  • Tumor Lysis Syndrome (etiology)
  • Urate Oxidase (adverse effects, blood, pharmacokinetics, therapeutic use)
  • Uric Acid (blood)

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