Recombinant urate oxidase (Rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies: Results of a compassionate prospective multicenter study in Korea.
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.


METHODS
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 (< or =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.


CONCLUSIONS
This study confirms that rasburicase is a safe and effective agent for the treatment of hyperuricemia associated with hematologic malignancies in pediatric patients.
Shin
Hee Young
HY
Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea.
Kang
Hyoung Jin
HJ
Park
Eun Sil
ES
Choi
Hyoung Soo
HS
Ahn
Hyo Seop
HS
Kim
Sun Young
SY
Chung
Nak Gyun
NG
Kim
Hack Ki
HK
Kim
So Youn
SY
Kook
Hoon
H
Hwang
Tai Ju
TJ
Lee
Kwang Chul
KC
Lee
Sun Min
SM
Lee
Kun Soo
KS
Yoo
Keon Hee
KH
Koo
Hong Hoe
HH
Lee
Mee Jung
MJ
Seo
Jong Jin
JJ
Moon
Hyung Nam
HN
Ghim
Thad
T
Lyu
Chuhl Joo
CJ
Lee
Won Sik
WS
Choi
Yong Mook
YM
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D033461:Hyperuricemia / Q000150:complications* / Q000188:drug therapy*; D007223:Infant; D007231:Infant, Newborn; D007723:Korea / Q000453:epidemiology; D008297:Male; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D006435:Renal Dialysis; D016896:Treatment Outcome; D014503:Urate Oxidase / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014527:Uric Acid / Q000097:blood
D011994:Recombinant Proteins; C469709:rasburicase; D014527:Uric Acid; D014503:Urate Oxidase