항암화학요법에 의하여 골수억제가 수반된 진행암 환자에서 Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor(rh GM-CSF, LBD-005)의 제 3 상 임상연구; rh GM-CSF 의 백혈구 감소증에 대한 효과
A Phase III Clinical Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor(rhGM-CSF, LBD-005) in Cancer Patients with Chemotherapy-induced Myelosuppression
대한암학회지 1995년 27권 5호 p.804 ~ 815
소속 상세정보
이경희
라선영/노재경/이종인/이혜란/박준오/조재용/정현철/김주항
KMID : 0360319950270050804
Abstract
Background:
@EN Recombinant human granulocyte-macrophage colony stimulating factor(rhGMCSF, I. BD-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 Ⅱstudies, clinical efficacies and side effects of rhGM-CSF were evaluated, and the dose of250μg/m*/day for 10 consecutive days subcutaneous administration was recommended for the further clinical trial.
@ES Methods:
@EN In this phase Ⅲ trial, we evaluated the efficacy and safety of rhGM-CSF in 35 advanced cancer patients 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, rh GM-CSF was administered for 10 consecutive days subcutaneously with the dose of 250μg/m*/day after the same chemotherapy
given
previously. During observation and treatment period, clinical and pathological effects were monitered.
@ES Results:
@EN 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*(241/mm끝*242) and 2,486±1,554/mm*(921±1,186/mm*) 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 administration; 7 days during control period and 10 days during treatment period). Most patients showed mild, tolerable toxicities like chest tightness and general malaise, except 2 patients with the reduced dose of 150μg/m*/day due
to
grade Ⅱtoxicities of chest tightness and abdominal pain.
@ES Conclusion:
@EN 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.
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