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.
Kikuchi
Akira
A
Division of Hematology/Oncology, Saitama Children's Medical Center, Saitama, Japan. akikuchi-tky@umin.ac.jp.|Department of Pediatrics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo Bunkyo-ku, Tokyo, 113-8655, Japan. akikuchi-tky@umin.ac.jp.
Kigasawa
Hisato
H
Department of Hemato-oncology/Regeneration Medicine, Kanagawa Children's Medical Center, Yokohama, Japan.
Tsurusawa
Masahito
M
Department of Pediatrics, Aichi Medical University Hospital, Aichi, Japan.
Kawa
Keisei
K
Department of Hematology/Oncology, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.
Kikuta
Atsushi
A
Department of Pediatrics, Fukushima Medical University Hospital, Fukushima, Japan.
Tsuchida
Masahiro
M
Department of Pediatrics, Ibaraki Children's Hospital, Mito, Japan.
Nagatoshi
Yoshihisa
Y
Department of Pediatrics, National Kyushu Cancer Center, Fukuoka, Japan.
Asami
Keiko
K
Department of Pediatrics, Niigata Cancer Center Hospital, Niigata, Japan.
Horibe
Keizo
K
Department of Pediatrics, National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.
Makimoto
Atsushi
A
Department of Pediatrics, National Cancer Center Hospital, Tokyo, Japan.
Tsukimoto
Ichiro
I
Children's Center, Saiseikai Yokohamasi Tobu Hospital, Yokohama, Japan.
D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004342:Drug Hypersensitivity / Q000150:complications; D005260:Female; D019337:Hematologic Neoplasms / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D033461:Hyperuricemia / Q000188:drug therapy* / Q000209:etiology; D007223:Infant; D008297:Male; D011994:Recombinant Proteins / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome; D015275:Tumor Lysis Syndrome / Q000209:etiology*; D014503:Urate Oxidase / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014527:Uric Acid / Q000097:blood
D011994:Recombinant Proteins; C469709:rasburicase; D014527:Uric Acid; D014503:Urate Oxidase
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