Effect of Leukokine in Patients with Acute Leukemia Receiving Induction Chemotherapy.
- Author:
Sun Young KIM
1
;
Pil Sang JANG
;
Nak Gyun CHUNG
;
Dae Chul JEONG
;
Bin CHO
;
Hack Ki KIM
;
Kun Soo LEE
;
Hyoung Jin KANG
;
Hyoung Soo CHOI
;
Hee Young SHIN
;
Hyo Seop AHN
;
Churl Joo LYU
;
Chang Hyun YANG
;
Tai Ju HWANG
;
Kyoo Hyung LEE
Author Information
1. Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul, Korea. hakkikim@cmc.cuk.ac.kr
- Publication Type:Original Article ; Randomized Controlled Trial
- Keywords:
Acute leukemia;
Leukokine;
Grasin
- MeSH:
Drug Therapy;
Granulocyte Colony-Stimulating Factor;
Humans;
Induction Chemotherapy*;
Injections, Subcutaneous;
Leukemia*;
Neutropenia;
Neutrophils;
Physical Examination
- From:Korean Journal of Pediatric Hematology-Oncology
2003;10(2):206-213
- CountryRepublic of Korea
- Language:Korean
-
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.
