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Title   항암호학요법에 의하여 골수억제가 수반된 진행암 환자에서 Recombinant Human Granulocyte Colony - Stimulating Factor ( fhG - CSF ) ( KRN8601 ) 의 제 2 상 임상연구 ( Phase 2 Clinical Trial of Recombinant Human Granulocyte Colony - Stimulating Factor ( fhG - CSF ) ( KRN8601 ) in Adanced Can
Publicationinfo   1993 Jan; 025(05): 725-736.
Key_word   Cancer chemotherapy, Myelosuppression, rhG-CSF
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Abstract   Background: At the myeloid progenitor cell level, G-CSF stimulates the growth of neutrophil granulocyte precursors. To prove its clinical usefullness, we planned to administer rhG-CSF to prevent or overcome myclosuppression after chemotherapy. Methods: rhG-CSF was started 1 day after chemotherapy in preventive trial and at nadir of myelosuppression in therapeutic trial(75 ug/day subcutaneously for 10 days). Results: All the enrolled 36 patients were evaluable, which consisted of 11 with stomach cancer, 7 with malignant lymphoma, 6 with lung cancer, 4 with osteosarcoma, 2 with breast cancer, ovarian cencer, glioblastoma multiforme, and 1 with choriocarcinoma, neuroblastoma, respectively. The male to female was 1: 1, with median age of 50(13~73); The commonly used chemotherapeutic agents were VF-16, cisplatin, adriamycin. Twenty five patients were treated with rhG-CSF to prevent chemotherapy induced neutropenia; 14 of these patients received rhG-CSF with observation period(controlled trial group), 11 patients without(uncontrolled trial group). rhG-CSF was administered to 11 patients f'or treatment of chemotherapy induced se- vere neutropenia and infection(rescue therapy group).: The mean nadir of WBC counts during the observation period and treatment period were 928.6+-385.5/mm(3) and 2810.7+-1937.7/mm(3), respectively(p=0.004) in conrolled trial group, and 1760.0+-1004.0/mm(3) in uncontrolled trial group. In controlled trial group, the mean duration of WBC count less than 4,000/mm(3) were 9.9+-5.5 days in the observation period and 2.3+-1.6 days in the treatment period(p<0.001) 4.5+2.6 days in uncontrolled trial group. The recovery time of WBC from nadir to >3,000/mm(3) was 5.4+-4.2 days in rescue therapy group. In controlled trial group, the incidence of infection was decreased in rhG-CSF treated period. The G-CSF related toxicities were mild bone pain, fever, general weakness, and myalgia. Conclusion: This study proved the effects of rhG-CSF to prevent or overcome the chemo- therapy induced myclosuppression in cancer patients.
저 자   노재경(Jae Kyung Roh),최진혁(Jin Hyuk Choi),이경희(Kyung Hee Lee),이혜란(Hye Ran Lee),유내춘(Nae Chun Yoo),김주항(Joo Hang Kim),김병수(Byung Soo Kim),임호영(Ho Yeong Lim)