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 GhimChuhl Joo Lyu, Won Sik Lee, Yong Mook Choi

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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

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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

Shin, H. Y., Kang, H. J., Park, E. S., Choi, H. S., Ahn, H. S., Kim, S. Y., Chung, N. G., Kim, H. K., Kim, S. Y., Kook, H., Hwang, T. J., Lee, K. C., Lee, S. M., Lee, K. S., Yoo, K. H., Koo, H. H., Lee, M. J., Seo, J. J., Moon, H. N., ... Choi, Y. M. (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, 46(4), 439-445. https://doi.org/10.1002/pbc.20555