Korean J Pediatr Hematol Oncol.  2003 Oct;10(2):206-213.

Effect of Leukokine in Patients with Acute Leukemia Receiving Induction Chemotherapy

Affiliations
  • 1Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul, Korea. hakkikim@cmc.cuk.ac.kr
  • 2Department of Pediatrics, Kyungpook National University School of Medicine, Daegu, Korea.
  • 3Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
  • 4Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
  • 5Department of Pediatrics, Chonnam National University Medical School, Gwangju, Korea.
  • 6Hematology-Oncology, Department of Internal Medicine, University of Ulsan, Asan Medical Center, Seoul, Korea.

Abstract

PURPOSE
Neutropenia is common in patients receiving myelotoxic chemotherapy. The aim of this study is to compare the efficacy, safety and adverse events between prophylactically administered Leukokine and Grasin. METHODS: An open-label, randomized, phase III study was designed to compare the effects of a subcutaneous injection of Leukokine (CJ Corp.) 100mug/m2 with Grasin (Jeil Pharm. Inc.) in patients receiving induction chemotherapy for acute leukemia. All patients received one dose of G-CSF every day during the study period. Total period of G-CSF injection was not over 14 days. The administration of G-CSF began on day 14 after beginning of chemotherapy under CCG strategy. In other chemotherapies, the injection of G-CSF started on day 1 from end of chemotherapy. Injection of G-CSF stopped after absolute neutrophil count recovery was achieved. RESULTS: The median numbers of times of administration were 9.6 (2~14) /cycle for Leukokine and 8.8 (2~14) /cycle for Grasin. The time to needed for neutrophil recovery more than 1, 000/mm3 was 6.6 4.9 day and 4.7 4.8 day of the Leukokine and Grasin, respectively (P=0.14). The mean duration of neutropenia less than 500/mm3 was 7.6 5.6 days for Leukokine and 6.1 6.0 days for Grasin (P=0.28). The results for the two groups were also not significantly different in adverse events, physical examination and laboratory findings. CONCLUSION: Leukokine was safe and well tolerated in these patients population. Injection of Leukokine provided neutrophil recovery with safety and efficacy similar to that provided by Grasin.

Keyword

Acute leukemia; Leukokine; Grasin

MeSH Terms

Drug Therapy
Granulocyte Colony-Stimulating Factor
Humans
Induction Chemotherapy*
Injections, Subcutaneous
Leukemia*
Neutropenia
Neutrophils
Physical Examination
Granulocyte Colony-Stimulating Factor
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