A Multicenter, Phase III Clinical Trial of $Leucogreen^{\circledR}$(G-CSF) for Chemotherapy-Induced Neutropenia in Solid Tumors

고형암 환자에서 항암화학요법 후 발생한 호중구감소증에 대한 류코그린$^{\circledR}$(G-CSF)의 제3상 다기관 공동 임상시험

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.

항암화학요법을 시행받는 고형암 환자에서 류코그린$^{\circledR}$은 기존에 임상에서 사용되고 있는 대조약과 비교하여 호중구감소증의 예방률, 기간, 최저치 면에서 효능이 다르지 않았으며 시험약과 관련된 이상반응은 대조약과 비슷하고 심각하지 않았다.