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Title   진행된 악성종양 환자에서 Recombinant Human Granulocyte - Macrophage Colony - Stimulating Factor ( LBD - 005 ) 의 제 1 상 임상연구 ( Phase 1 Study of Subcutaneously Administered Recombinant Human Granulocyte - Marcrophage Colony Stimulating Factor ( GM - CSF ) in Patients w
Publicationinfo   1993 Jan; 025(04): 520-531.
Key_word   rhGM-CSF, Phase I study, Advanced malignancy
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Abstract   A phase I study of yeast-derived recombinant human granulocyte-macrophage colony stimulating factor(rhGM-CSF) was undertaken in 27 patients with advanced malignancy. rhGM-CSF was administered once daily by subcutaneous(SC) injection(l0 to 500 ug/m/day) for 10 days. In present study, the maximum tolerated dose(MTD) was not reached up to the dose 500 ug/ m(2)/day, but the dose-dependent increment of circulating granulocytes has been demonstrated and a plateau of hematologic effect was observed at rhGM-CSF dose in the range of 150 to 350 ug/m/day. The most common adverse drug events were fever(41%), bone pain/myalgia(26%), and skin rash(15%), but they were mild and well tolerated. Following a single SC injection at dosage levels of 50 to 500 ug/m/day, detectable serum levels occured within 30 minutes, peaked at 3.1+-3.1 hours(mean+-SD) and peak concentration were positively associated with dosage, followed by a raPid decrease accurring with a half life of 1.7+ 0.6(mean+-SD). Further studies will determine the impact on infection, morbidity, and mortality in patients wha receive intensive anticancer chemotherapy. The optimal dose level of rhGM-CSF to be used in phase II study is suggested to be in the range of 150 to 350 ug/m(2)/day.
저 자   이정애(Jung Ae Rhee),김현아(Hyun Ah Kim),이경훈(Kyung Hoon Lee),양성현(Sung Hyun Yang),허대석(Dae Seog Heo),방영주(Yung Jue Bang),김병국(Byoung Kook Kim),김노경(Noe Kyeong Kim)