| 항암화학요법에 의하여 골수억제가 수반된 진행암 환자에서 Recombinant Human Granulocyte - Macrophage Colony Stimulating Factor ( rhGM-CSF , LBD-005 ) 의 제 3 상 임상연구 : rhGM-CSF 의 백혈구 감소증에 대한 효과 |
| 이경희, 라선영, 노재경, 이종인, 이혜란, 박준오, 조재용, 정현철, 김주항, 한지숙, 고윤용, 김병수, 임호영, 최진혁 |
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| A Phase 3 Clinical Trial of Recombinant Human Granulocyte - Macrophage Colony Stimulating |
| Kyung Hee Lee, Sun Young Rha, Jae Kyung Roh, Jong In Lee, Hae Ran Lee, Jun Oh Park, Jae Woong Cho, Hyun Cheol Chung, Joo Hang Kim, Jee Sook Hahn, Yun Woong Ko, Byung Soo Kim, Ho Young Lim, Jin Hyuk Choi |
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| 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
Method:
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. |
| Key words:
rhGM-CSF, Cancer patients, Combinetion chemotherapy, Myelosuppression |
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