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KMID : 0391319940040020193
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Korean Journal of Biological Response Modifiers
1994 Volume.4 No. 2 p.193 ~ p.202
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A Phase III Study on the Effect of Leukogen(r)(Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor) on Myelosuppression Induced by Chemotherapy in Patients with Lung Cancer and Gastric Cancer
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문한림
강윤구/김병국/김준석/김형준/박재후/박희숙/손창학/송홍석
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Abstract
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Purpose:
@EN This study was conducted to evaluate the efficacy and toxicity of Leukogen(r)(recombinant human GM-CSF) for chemotherapy induced neutropenia in lung cancer and gastric cancer patients.
@ES Method:
@EN At the first cycle of chemotherapy, Leukogen(r) was not administered. If nadir leukopenia<2,000/㎣ or neutropenia<1,000/㎣ was developed, after second cycle of VAP(etoposide 120mg/m2/day I.V., dl-3, adriamycin 40mg/m2 I.V. d1, cisplatin
25mg/m2/day
I.V., d1-3) for advanced lung cancer patients EFP(etoposide 100mg/m2/day I.V., d3-5, 5-fluorouracil 800mg/m2/day I.V., d1-5, cisplatin 20mg/m2/day I.V., d1-5) for advanced gastric cancer patients, 250ug/m2/day of Leukogen was administered s.c.
for
10
consecutive days initiating on the day after chemotherapy completed .
@ES Result:
@EN Of 44 patients(lung cancer 30, gastric cancer 14) enrolled, 43 patients were evaluable for efficacy of Leukogen(r) and all 44 patients were evaluable for toxicity. Duration of leukopenia (less than 2,000/㎣ and 4,000/㎣) was significantly
reduced in
second cycle of chemotherapy with rhGM-CSF(p<0.0001 and p<0.0003). The nadir leukocyte(1278+671, 2076+1091, p=0.0001) and neutrophil (151+180, 586+663, p=0.0001) count was also significantly higher in GM-CSF cycle. The duration of fever,
infection
and
antibiotic use was also significantly decreased(p=0.03, p=0.0008, p=0.0001) with GM-CSF. Adverse effects9fever, myalgia, nausea. Headache, abdominal pain, bone pain, etc) during rhGM-CSF administraton were relatively mild and tolerable in most of
patients. leukogen was stopped in only one patient who showed grade II dyspnea and generalized rash on the first day.
@ES Conclusion:
@EN Leukogen(r) was considered effective to counteract with chemotherapy-induced myelosuppression and subsequent infection and tolerable without serious toxicity.
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KEYWORD
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