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KMID : 0358419960390081512
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Korean Journal of Obstetrics and Gynecology
1996 Volume.39 No. 8 p.1512 ~ p.1522
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Clinical Effect of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor(Leucogen, LBD-005) in Patients with
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남주현
김종혁/김용만/김영탁/목정은
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Abstract
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cologic Malignancy Accompained by Chemotherapyinduced Neutropenia
@EN Recombinant human granulocyte-macrophage colony-stimulating factor(rhGM-CSF, Leucogen, LBD-005) may reduce the degree of chemotherapy-induced neutropenia, and thus better observance of dose and schedule of chemotherapy. In previous phase I
and
II
studies, clinical efficiencies and side effects of rhGM-CSF were evaluated, and the dose of 250μg/m*/day 10 consecutive days subcutaneous administration was recommended for the further clinical trial. The objective of this phase III trial was to
investigate the efficiency and safety of rhGM-CSF in 31 patients with ovarian cancer and uterine cervix cancer who received two courses of combination chemotherapy.
In the first course of chemotherapy as a control course, all patients were treated with combination chemotherapy alone and during the second course, rhGM-CSF was given with the dose of 250μg/m*/day for 10 consecutive days subcutaneously 24 hours
after
completion of chemotherapy.
Leucogen significantly increased the nadir count of absolute neutrophil(612.9±17.38/μl vs 1202.9±413.1/μl, mean ±S.D.) and leukocyte(1651.1±209.6/μl vs 2664.5±577.7/μl) and decreased the number of days per patient of patient of which the
absolute neutrophil count was 1,000/μl or less(5.9±2.2 vs 1.1±1.5). The mean recovery time required for neutrophil to be greater than 1,500/μl after nadir significantly decreased in the second course as compared with the first
course(15.1±3.9
vs
5.4±2.2). Incidence of infection and necessities of antibiotics administration were decreased(22.6% vs 0%). Only five patients(16.1%) showed grade I side-effects of Leucogen, such as fever, reaction at injection sites, generalized itching and
myalgia,
and recovered without treatment.
These results showed that the administration of rhGM-CSF after chemotherapy can reduce the degree of chemotherapy-induced neutropenia effectively, and the side effects of rhGM-CSF were well acceptable in patients with gynecologic malignancies.
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KEYWORD
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