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KMID : 0360319950270030490
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Journal of Korean Cancer Research Association
1995 Volume.27 No. 3 p.490 ~ p.503
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A Phage II Clinical Trial of Recombinant Human Granulocyte Macrophage Colony Stimulating Factor )rh GM-CSF, LBD-005) in Cancer Patients with Chemotherapy induced Myelosuppression; Dose-response Effect of rh GM-CSF
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라선영
노재경/이경희/정현철/이종인/조재용/이혜란/유내춘/김주항
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Abstract
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Background;
@EN Rh GM-CSF is known to stimulate the growth of granulocyte-macrophage precursors and can prevent the neutropenia and infection after high dose chemotherapy. We planned to evaluate the efficacy and toxicities of rh GM-CSF and to determine the
clinically recommended dose of yeast-derived rh GM-csf(lbd-005), based on the biologically active doses from phases I clinical trial.
@ES Methods;
@EN Open non-randomized phase Ⅱstudy was carried out in 40 cancer patients with chemotherapy induced myelosuppression. After the control period(chemotherapy without rh GM-CSF), rh GM-CSF was started 24 hours after the second chemotherapy to 3
groups of
patients with the doses of 150, 250, 350μg/m*/d by once-daily subcutaneous administration for 10 days.
@ES Results;
@EN Of the 40 enrolled patients, two patients refused to be followed and one patient couldn't finish the study due to the disease progression. So 37 patients were evaluable and the number of patients at the dose of 150, 250, 350μg/m*/d were 12,
12
and
13 patients, respectively. They were consisted of 12 with stomach cancers, 10 with breast cancers, 5 with osteosarcoma and 10 patients with other malignancies, and received chemotherapeutic agents like VP-16, cisplatinum, adriamycin.
When we compare the hematologic parameters between the control and treatment periods, the mean nadir of WBC counts(/mm*) at the dose of 150μg/m*/d were 1480, 2085, each, 1280, 1997 at the dose of 250μg/m*/d, and 1091, 1788 at the dose of
350μg/m*/d
respectively. Also the recovery days of WBC counts from nadir to 4000/* were improved from 8 days in control period to 4.7 days in treatment period at the dose of 150μg/m*/d. there were the same results at the dose of 250 and 350μg/m*/d, such
as
from
7.4 days to 4.4 days and from 8.5 days to 5.2 days, respectively. In view of neutrophils, we could find the same results(p<0.05).
There are trends that the recovery from nadir at the dose of 250μg/m*/d or more is rapid, rather than 150μg/m*/d. Two patients with 350μ/m*/d complained of severe(WHO toxicity grade Ⅲ) skin reaction and chest tightness, but they tolerated
well
after
reduction to 250μg/m*/d dose.
@ES Conclusion; This study suggested the effects of yeast-derived rh GM-CSF with the dose of 15, 250, 350μg/m*/d, S.Q. for 10 days to prvent the chemotherapy induced neutropenia. And when we considered the efficacy and tolerability, 250μg/m*/d
is
appropriate for phase Ⅲclinical trial.
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KEYWORD
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