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Recombinant urate oxidase (Rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies: Results of a compassionate prospective multicenter study in Korea
Author(s) -
Shin Hee Young,
Kang Hyoung Jin,
Park Eun Sil,
Choi Hyoung Soo,
Ahn Hyo Seop,
Kim Sun Young,
Chung Nak Gyun,
Kim Hack Ki,
Kim So Youn,
Kook Hoon,
Hwang Tai Ju,
Lee Kwang Chul,
Lee Sun Min,
Lee Kun Soo,
Yoo Keon Hee,
Koo Hong Hoe,
Lee Mee Jung,
Seo Jong Jin,
Moon Hyung Nam,
Ghim Thad,
Lyu Chuhl Joo,
Lee Won Sik,
Choi Yong Mook
Publication year - 2006
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.20555
Subject(s) - rasburicase , hyperuricemia , medicine , tumor lysis syndrome , uric acid , urate oxidase , adverse effect , prospective cohort study , gastroenterology , surgery , chemotherapy
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. Pediatr Blood Cancer 2006, 46:439–445. © 2005 Wiley‐Liss, Inc.