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KMID : 0882420050690010061
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Korean Journal of Medicine
2005 Volume.69 No. 1 p.61 ~ p.68
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Efficacy and safety of Leukoup(R) (Filgrastim, rhG-CSF) for chemotherapy induced neutropenia in solid tumors: A randomized, multicenter, phase 3 comparison with Grasin(R)
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Lee So-Young
Heo Dae-Seok
Ryu Min-Hee
Kang Yoon-Koo
Kim Tae-You
Park Youn-Hee
Park Keun-Chil
Ryu Baek-Ryul
Lee Jae-Hoon
Kim Tae-Won
Chang Heung-Moon
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Abstract
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Background:It is a well known fact that granulocyte colony-stimulating factor (G-CSF) can reduce the severity and duration of neutropenia after chemotherapy. The aim of this study was to evaluate the efficacy and safety of newly developed G-CSF, Leukoup(R) by comparing with those of already approved G-CSF, Grasin(R).
Methods:This study was designed as a randomized, multicenter, open label, phase III trial. Both G-CSFs were subcutaneously injected at the dose of 50 g/m2 daily from 24 hours after the end of chemotherapy and continued for 10 days. The primary end point was the time for neutrophil recovery to 2,000/mm3.
Results:A total of 222 patients were enrolled in this study (110 for Leukoup(R) arm, 112 for Grasin(R) arm), and 184 completed the study. The mean of the days for neutrophil recovery in Leukoup(R) arm was 16.5 days, and that of Grasin was 15.9 days; the difference between two groups was 0.67 days, and 95% confidence interval was 1.51~2.86 days. Although the difference in neutrophil recovery between the two groups is not significantly different and still within the usual non-inferiority margin (50% of difference between G-CSF group and no treatment group: 3.15 days), this study couldn’t demonstrate the non-inferiority of Leukoup(R) to Grasin(R) by pre-defined noninferiority margin (30% of difference between G-CSF group and no treatment group: 1.89 days). The results of other assessment points, the incidence and severity of adverse events showed no difference between the two groups.
Conclusiont:The present study showed that Leukoup(R) was effective and safe as good as Grasin(R) for the prevention of chemotherapy-induced neutropenia, although the noninferiority of Leukoup(R) to Grasin(R) could not be demonstrated by the predefined non-inferiority margin.
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KEYWORD
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Neutropenia, Prevention, Granulocyte colony-stimulating factor, G-CSF
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