항암화학요법에 의하여 골수억제가 수반된 진행암 환자에서 Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor(rhGM-CSF,LBD-005)의 제3상 임상연구;rhGM-CSF의 백혈구 감소증에 대한 효과

Abstract

Background: Recombinant human granulocyte-macrophage colony stimulating factor(rhGM- CSF, LBD-005) may reduce chemotherapy induced myelosuppression, and thus reduce the incidence of neutropenic fever and infection after the dose intensive chemotherapy. In previous phase I and II studies, clinical efficacies and side effects of rhGM-CSF were evaluated, and the dose of 250ug/m(2)/day for 10 consecutive days subcutaneous administration was recommended for the further clinical triaL Methods: In this phase III trial, we evaluated the efficacy and safety of rhGM-CSF in 35 advanced cancer pstients after combination chemotherapy. Every eligible patients received at least 2 cycles of chemotherapy with the same dose and schedule. At the first cycle, control period, scheduled chemotherapy was given without rhGM-CSF, and at the second cycle, treatment period, rhGM-CSF was administered for 10 consecutive days subcutaneously with the dose of 250u/m(2)/day after the same chemotherapy given previously. During observation and treatment period, clinical and pathoiogical effects were monitered. Resnlta: All enrolled 35 patients were evaluable, and 14 patients(40%) had stomach cancer. The hematologic parameters were compared between two periods; mean nadir of WBC(neutrophil) counts during the control period and treatment period were 1,154+-485/mm(3)(241/mm(3)+ 242) and 2,486+1,554/mm(3)(912+-1,186/mm(3)) respectively(P<0.0001). Also the recovery time of neutropenia was shortened(P<0.0001). Incidence of infection and the necessities of antibiotics administration were decreased(days of antibiotics adminiatration: 7 days during control period and 10 days during treatment period). Most petients showed mild, talerable toxicities like chest tightness and general malaise, except 2 patients with the reduced dose of 150 ug/m(2)/day due to grade II toxicities of chest tightness and abdominal pain. Conclnsion: Above results suggested that the administration of rhGM-CSF after chemotherapy can reduce the degree of neutropenia and the side effects of rhGM-CSF were acceptable.