진행성 악성종양 환자에서 화학요법 후 발생한 호중구 감소증에 대한 Leukokine (Filgrastim, 고G-CSF) 의 유호성 및 안전성을 평가하기 위한 무작위 선정 타 약물 비교 공개 제 III상 임상시험

Abstract

Purpose: The aim of this study was to evaluate the effectiveness and toxicity of newly developed rhG-CSF (Filgrastim; Leukokine®, Cheiljedang Co., Korea). Methods: This study was designed as an open randomized active control comparative cross-over phase Ⅲ study involving Leukokine® and Gracin® (Amgen/Kirin Co, USA/Japan). rhG-CSF was subcutaneously injected with the dose of 75 ㎍/day from 24 hours after the end of chemotherapy and continued for 14 days. The main point of assessment was the duration of neutrophil recovery to 2,000/㎣. Moreover, 'neutropenia duration', 'nadir count of neutrophil' and 'the duration of recovery from neutropenia to normal status', were assessed. The toxicity was evaluated with WHO criteria. Results: 91 patients were enrolled in this study, and seventy four were possible for assessment. The main assessment point was evaluable in 50 patients. The neutrophil recovery duration to 2,000/㎣ of Leukokine® group (14.14±3.48 days) showed no difference with that (13.98±2.52 days) of Gracin® group (P=0.7723). And, the results of other assessment points revealed no difference between the Leukokine® group and Gracin® group. The toxicity was found in seven cases and all were mild and controllable with symptomatic cares. Conclusion: Leukokine® has the same effectiveness and safety alike with those of Gracin® for the control of the neutropenia induced by myelo-suppressive chemotherapy in advanced cancer patients.