Abstract
Background. Hyperuricemia accompanying tumor lysis syndrome is a serious complication in neoplasia with rapid proliferation and destruction. To confirm the efficacy of recombinant urate oxidase (rasburicase) and its safety profile, a phase IV compassionate use prospective study was performed in Korean pediatric patients with hematologic malignancies. Procedure. Rasburicase was administered at 0.2 mg/kg/day once daily for 3-5 days (twice daily allowed during the first 72 hr) by intravenous route for hyperuricemia (uric acid > 7.5 mg/dl). The study period was 5 weeks and consisted of a baseline assessment within 48 hr before the administration of rasburicase, 3-5 days of assessment during treatment and a follow-up assessment at 4 weeks after its final administration. Results. The uric acid endpoint (≤7.0 mg/dl) was reached in 97.3% (36/37) of the patients and uric acid levels were significantly reduced in all patients (P < 0.001). Drug related toxicities were mild and reversible without any grade 4 or serious adverse event associated with rasburicase. Conclusion. This study confirms that rasburicase is a safe and effective agent for the treatment of hyperuricemia associated with hematologic malignancies in pediatric patients.
Original language | English |
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Pages (from-to) | 439-445 |
Number of pages | 7 |
Journal | Pediatric Blood and Cancer |
Volume | 46 |
Issue number | 4 |
DOIs | |
Publication status | Published - 2006 Apr |
Externally published | Yes |
Keywords
- Compassionate study
- Hematologic malignancy
- Hyperuricemia
- Pediatric patients
- Rasburicase
- Tumor lysis syndrome
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Hematology
- Oncology