Recombinant urate oxidase (rasburicase) for the prevention and treatment of tumor lysis syndrome in patients with hematologic malignancies.
In this multicenter, nonrandomized, open-label clinical trial conducted from July 2003 to July 2004, recombinant urate oxidase (rasburicase) was administered to patients at risk for tumor lysis syndrome before or during the initiation of chemotherapy. Forty-five patients were enrolled, including 18 children (10 with acute lymphoblastic leukemia, 6 with high-grade lymphoma, and 2 with acute myeloid leukemia) and 27 adults (8 with acute lymphoblastic leukemia, 4 with high-grade lymphoma, 9 with multiple myeloma, and 6 with acute myeloid leukemia). The age ranged from 3 to 98 years, with a median age of 7 years in children and 59.3 years in adults. There were 14 males and 4 females in the pediatric group and 18 males and 9 females in the adult group. Rasburicase 0.2 mg/kg was administered intravenously once a day for 2-6 days, for a median of 3 days in children and of 4 days in adults. After 3 days of treatment, the median uric acid levels in the 18 children decreased from 10.5 mg/dl (range 8-18.6) to 0.5 mg/dl (range 0.0-1.7). Similarly, in the 27 adults, the median levels decreased from 10.8 mg/dl (range 8-24.4) to 0.5 mg/dl (range 0.0-1.6). No significant changes were observed in serum potassium, calcium, and phosphorus concentrations. None of the patients required dialysis for acute renal failure. Rasburicase was very well tolerated, with only 1 adult having grade 1 vomiting. We conclude that rasburicase is safe and highly effective for preventing the complications of tumor lysis syndrome in patients with hematologic malignancies.
Wang
Lin-Yen
LY
Division of Hematology-Oncology, Department of Pediatrics, Mackay Memorial Hospital, Taipei, Taiwan.
Shih
Lee-Yung
LY
Chang
Hung
H
Jou
Shiann-Tarng
ST
Lin
Kai-Hsin
KH
Yeh
Ting-Chi
TC
Lin
Sheng-Fung
SF
Liang
Der-Cherng
DC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002118:Calcium / Q000097:blood; D002648:Child; D002675:Child, Preschool; D005260:Female; D019337:Hematologic Neoplasms / Q000097:blood / Q000150:complications; D006801:Humans; D007275:Injections, Intravenous; D007938:Leukemia / Q000097:blood / Q000150:complications; D008228:Lymphoma, Non-Hodgkin / Q000097:blood / Q000150:complications; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood; D011188:Potassium / Q000097:blood; D012307:Risk Factors; D015275:Tumor Lysis Syndrome / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D014503:Urate Oxidase / Q000008:administration & dosage*; D014527:Uric Acid / Q000097:blood
C469709:rasburicase; D014527:Uric Acid; D010758:Phosphorus; D014503:Urate Oxidase; D011188:Potassium; D002118:Calcium