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KMID : 0391020030110010038
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2003 Volume.11 No. 1 p.38 ~ p.47
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A Multicenter, Phase III Clinical Trial of $Leucogreen^{\circledR}$(G-CSF) for Chemotherapy-Induced Neutropenia in Solid Tumors
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Lee Se-Hoon
Kim Noe-Kyeong
Heo Dae-Seok
Bang Young-Jue
Kim Tae-You
Lee Jae-Hoon
Im Young-Hyuck
Kang Yoon-Gu
Cho Eun-Kyung
Kim Won-Seog
Kim Tae-Won
Bang Soo-Mi
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Abstract
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Background : Neutropenia is the main cause of therapy-related mortality in the patients who receive cytotoxic chemotherapy. Granulocyte colony-stimulating factor (G-CSF) can reduce the neutropenic severity and duration after cytotoxic chemotherapy. We performed a randomized, controlled, cross-over study of two G-CSF {(Leucogreen^{circledR};and;control;drug)} in the solid tumor patients who would receive cytotoxic chemotherapy.
Methods :Patients received Leucogreen^{circledR} in the first cycle and control drug in the second cycle, or vice versa. They should have received at least two cycles of same chemotherapy for their solid tumor. They were administered G-CSF 50{\mu}g/m^2 daily for 10 days since 24 hours after the last dose of chemotherapy.
Results :Eighty-three patients received at least one dose of G-CSF, and 61 patients completed two cycles of G-CSF without major protocol violation. The prophylactic rate of neutropenia (<1,000/mm^3)$ of test drug is 70.5%, and 95% confidence interval (CI) of the rate is 59.3-81.7%, which is included within the identical borderline (rate;of;control;drug;{pm};20%,;48.9-88.99%). Two drugs did not show any significant difference in respect of incidence of abnormal neutrophil count (<2,000/mm^3), nadir neutrophil count, duration of neutropenia and duration of abnormal neutrophil count Mild to moderate cause-related adverse events were observed during trial period and no significant difference in incidence and severity between two drugs.
Conclusion :Leucogreen^{circledR} showed similar efficacies for chemotherapy-induced neutropenia to control G-CSF and could safely be given.
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KEYWORD
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Granulocyte colony-stimulating factor, Chemotherapy, Neutropenia, Leucogreen^{circledR}
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