| 항암화학요법에 의하여 골수억제가 수반된 진행암 환자에서 Recombinant Human Granulocyte - Macrophage Colony Stimulating Factor ( rh GM - CSF , LBD - 005 ) 의 제 2 상 임상연구 : rh GM - CSF 용량에 따른 효과비교 |
| 라선영, 노재경, 이경희, 정현철, 이종인, 조재용, 이혜란, 유내춘, 김주항, 허대석, 최진혁, 임호영, 한지숙, 김병수 |
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| A Phase 2 Clinical Trial of Recombinant Human Granulocyte Macrophage Colony Stimulatin |
| Sun Young Rha, Jae Kyung Roh, Kyung Hee Lee, Hyun Cheol Chung, Jong Inn Lee, Jin Hyuk Choi, Hye Ran Lee, Nae Chun Yoo, Joo Hang Kim, Dae Seog Heo, Jin Hyuk Choi, Ho Yeong Lim, Jee Sook Hahn, Byung So |
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| ABSTRACT |
Background; Rh GM-CSF is known to stimulate the growth of granulocyte-macrophage pre- cursors 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 biologicaily active doses from phase I clinical triaL
Method
; Open non-randomized phase II study 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, 350 ug/m(2)/d by once-daily subcutaneous admlnistration for 10 days. Resnlts; 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, 350 pg/m/d were 12, 12 and 13 petients, 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 compared the hematologic parameters between the control and treatment periods, the mean nadir of WBC counts(/mm(3)) at the dose of 150ug/m(2)/d were 1480, 2085, each, l280, l997 at the dose of 250 ug/m/d, and 1091, 1788 at the dose of 350 ug/m(2)/d respectively. Also the recovery days of WBC counts from nadir to 4000/m(3) were improved from 8 days in control period to 4.7 days in treatment period at the dose of 150 ug/m(2)/d. There were the same results at the dose of 250 and 350 ug/m(2)/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 250 ug/m(2)/d or more is rapid, rather than l50ug/m(2)/d. Two patients with 350ug/m(2)/d complained of severe (WHO toxicity grade III) skin reaction and chest tightness, but they tolerated well after reduction to 250 ug/m(2) /d dose. Conclasion; This study suggested the effects of yeast-derived rh GM-CSF with the dose of 1SO, 250, 350ug/m(2)/d, S.Q. for 10 days to prvent the chemotherapy induced neutropenia. And when we considered the efficacy and tolerability, 250 ug/m(2)/d is appropriate for phase III clinical triaL |
| Key words:
Cancer patients, Myelosuppression, rh GM-CSF |
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