RESUMEN
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.