Recombinant urate oxidase (rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies

Results of a compassionate prospective multicenter study in Korea

Hee Young Shin, Hyoung Jin Kang, Eun Sil Park, Hyoung Soo Choi, Hyo Seop Ahn, Sun Young Kim, Nak Gyun Chung, Hack Ki Kim, So Youn Kim, Hoon Kook, Tai Ju Hwang, Kwang Chul Lee, Sun Min Lee, Kun Soo Lee, Keon Hee Yoo, Hong Hoe Koo, Mee Jung Lee, Jong Jin Seo, Hyung Nam Moon, Thad Ghim & 3 others Chuhl Joo Lyu, Won Sik Lee, Yong Mook Choi

Research output: Contribution to journalArticle

22 Citations (Scopus)

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 languageEnglish
Pages (from-to)439-445
Number of pages7
JournalPediatric Blood and Cancer
Volume46
Issue number4
DOIs
Publication statusPublished - 2006 Apr 1

Fingerprint

Urate Oxidase
Hyperuricemia
Hematologic Neoplasms
Korea
Multicenter Studies
Prospective Studies
Pediatrics
Uric Acid
Compassionate Use Trials
Tumor Lysis Syndrome
Therapeutics
Drug-Related Side Effects and Adverse Reactions
rasburicase
Safety
Neoplasms

Keywords

  • Compassionate study
  • Hematologic malignancy
  • Hyperuricemia
  • Pediatric patients
  • Rasburicase
  • Tumor lysis syndrome

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

Cite this

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

In: Pediatric Blood and Cancer, Vol. 46, No. 4, 01.04.2006, p. 439-445.

Research output: Contribution to journalArticle

Shin, HY, Kang, HJ, Park, ES, Choi, HS, Ahn, HS, Kim, SY, Chung, NG, Kim, HK, Kim, SY, Kook, H, Hwang, TJ, Lee, KC, Lee, SM, Lee, KS, Yoo, KH, Koo, HH, Lee, MJ, Seo, JJ, Moon, HN, Ghim, T, Lyu, CJ, Lee, WS & Choi, YM 2006, 'Recombinant urate oxidase (rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies: Results of a compassionate prospective multicenter study in Korea', Pediatric Blood and Cancer, vol. 46, no. 4, pp. 439-445. https://doi.org/10.1002/pbc.20555
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. / Recombinant urate oxidase (rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies : Results of a compassionate prospective multicenter study in Korea. In: Pediatric Blood and Cancer. 2006 ; Vol. 46, No. 4. pp. 439-445.
@article{3627d5234aea49d9b3b581946355c411,
title = "Recombinant urate oxidase (rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies: Results of a compassionate prospective multicenter study in Korea",
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.",
keywords = "Compassionate study, Hematologic malignancy, Hyperuricemia, Pediatric patients, Rasburicase, Tumor lysis syndrome",
author = "Shin, {Hee Young} and Kang, {Hyoung Jin} and Park, {Eun Sil} and Choi, {Hyoung Soo} and Ahn, {Hyo Seop} and Kim, {Sun Young} and Chung, {Nak Gyun} and Kim, {Hack Ki} and Kim, {So Youn} and Hoon Kook and Hwang, {Tai Ju} and Lee, {Kwang Chul} and Lee, {Sun Min} and Lee, {Kun Soo} and Yoo, {Keon Hee} and Koo, {Hong Hoe} and Lee, {Mee Jung} and Seo, {Jong Jin} and Moon, {Hyung Nam} and Thad Ghim and Lyu, {Chuhl Joo} and Lee, {Won Sik} and Choi, {Yong Mook}",
year = "2006",
month = "4",
day = "1",
doi = "10.1002/pbc.20555",
language = "English",
volume = "46",
pages = "439--445",
journal = "Pediatric Blood and Cancer",
issn = "1545-5009",
publisher = "Wiley-Liss Inc.",
number = "4",

}

TY - JOUR

T1 - Recombinant urate oxidase (rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies

T2 - Results of a compassionate prospective multicenter study in Korea

AU - Shin, Hee Young

AU - Kang, Hyoung Jin

AU - Park, Eun Sil

AU - Choi, Hyoung Soo

AU - Ahn, Hyo Seop

AU - Kim, Sun Young

AU - Chung, Nak Gyun

AU - Kim, Hack Ki

AU - Kim, So Youn

AU - Kook, Hoon

AU - Hwang, Tai Ju

AU - Lee, Kwang Chul

AU - Lee, Sun Min

AU - Lee, Kun Soo

AU - Yoo, Keon Hee

AU - Koo, Hong Hoe

AU - Lee, Mee Jung

AU - Seo, Jong Jin

AU - Moon, Hyung Nam

AU - Ghim, Thad

AU - Lyu, Chuhl Joo

AU - Lee, Won Sik

AU - Choi, Yong Mook

PY - 2006/4/1

Y1 - 2006/4/1

N2 - 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.

AB - 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.

KW - Compassionate study

KW - Hematologic malignancy

KW - Hyperuricemia

KW - Pediatric patients

KW - Rasburicase

KW - Tumor lysis syndrome

UR - http://www.scopus.com/inward/record.url?scp=33644679982&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33644679982&partnerID=8YFLogxK

U2 - 10.1002/pbc.20555

DO - 10.1002/pbc.20555

M3 - Article

VL - 46

SP - 439

EP - 445

JO - Pediatric Blood and Cancer

JF - Pediatric Blood and Cancer

SN - 1545-5009

IS - 4

ER -