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진행성 악성종양에서 항암약물요법에 의한 호중구 감소증에 대한 DA-3030(재조합 과립구 콜로니 자극인자: rhG-CSF)의 안전성 및 효과를 평가하기 위한 제 I/II상 임상시험
DC Field | Value | Language |
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dc.contributor.author | 김주항 | - |
dc.contributor.author | 노재경 | - |
dc.contributor.author | 라선영 | - |
dc.contributor.author | 안철우 | - |
dc.contributor.author | 유내춘 | - |
dc.contributor.author | 장윤수 | - |
dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2020-07-03T17:41:53Z | - |
dc.date.available | 2020-07-03T17:41:53Z | - |
dc.date.issued | 1997 | - |
dc.identifier.issn | 0496-6872 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/177766 | - |
dc.description.abstract | PURPOSE: We planned to evaluate the toxicity and efficacy of DA-3030 to determine the recommended dose for phase III clinical trial based on the biologically active doses from phase I/II clinical trial. MATERIALS AND METHODS: Open non-randomized phase I/II study was carried out in 64 cancer patients with chemotheray-induced myelosuppression. After 1 cycle of control period (chemotherapy without DA-3030), DA-3030 was started 24 hours after the second cycle of chemotherapy to 4 groups of patients with the doses of 50 microgram/m2/day (step I), 100 microgram/m2/day (step II), 150 microgram/m2/day (step III), 200microgram/m2/day (step IV) by once-a-day subcutaneous administration for 10 days. RESULTS: Of the 64 enrolled patients, 46 patients were evaluable. Tmax reached after 2 hours of injection in step I and 4 hours in step II-IV. Terminal half life was 1.8 hours in step I and 3.2 hours in step II, 3.3 hours in step III, 3.0 hours in step IV. Area under the curve (AUC) and AUMC increased dose dependently from step I through step IV. Total clearance rate decreased in a dose dependent manner but the volume of distribution showed no differences between the steps.The mean nadir count of total WBC and neutrophil increased in all 4 steps of DA-3030 administration. Also the duration of leukopenia, equal to or less than 2,000/uL or neutropenia and the recovery time of WBC or neutrophil from nadir decreased with DA-3030 administration in all 4 steps. But no differece of DA-3030 effect was found among 4 steps. When we compared the clinical efficacy of DA-3030 with total WBC and neutrophil criteria, it was 58.3% and 58.3% in step I, 90.0% and 80.0% in step II, 91.7% and 91.7% in step III, 75.0% and 70.0% in step IV. Although the duration of antibiotics administration showed no difference between control and DA-3030 administration period in step I, it decreased with DA-3030 administration in step II-IV. Infection was found only in step I. Life-threatening side effect was not found in all steps. Only mild myalgia was found without any dose relationship. CONCLUSION: When we considered the efficacy, toxicity and pharmacokinetic parameters, we suggest that 100microgram/m2 is an appropriate dosage for the phase III clinical trial. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | Korean | - |
dc.publisher | 대한암학회 | - |
dc.relation.isPartOf | Journal of the Korean Cancer Association (대한암학회지) | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 진행성 악성종양에서 항암약물요법에 의한 호중구 감소증에 대한 DA-3030(재조합 과립구 콜로니 자극인자: rhG-CSF)의 안전성 및 효과를 평가하기 위한 제 I/II상 임상시험 | - |
dc.title.alternative | A Phase I/II Trial of DA3030 in Chemotherapy Induced Neutropenia | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | 정현철 | - |
dc.contributor.googleauthor | 라선영 | - |
dc.contributor.googleauthor | 공수정 | - |
dc.contributor.googleauthor | 이화영 | - |
dc.contributor.googleauthor | 정희철 | - |
dc.contributor.googleauthor | 안철우 | - |
dc.contributor.googleauthor | 정욱진 | - |
dc.contributor.googleauthor | 이루다 | - |
dc.contributor.googleauthor | 정보영 | - |
dc.contributor.googleauthor | 이승근 | - |
dc.contributor.googleauthor | 장윤수 | - |
dc.contributor.googleauthor | 유내춘 | - |
dc.contributor.googleauthor | 김주항 | - |
dc.contributor.googleauthor | 노재경 | - |
dc.contributor.googleauthor | 민진식 | - |
dc.contributor.googleauthor | 김병수 | - |
dc.contributor.googleauthor | 박범수 | - |
dc.contributor.googleauthor | 방미영 | - |
dc.contributor.localId | A00945 | - |
dc.contributor.localId | A01290 | - |
dc.contributor.localId | A01316 | - |
dc.contributor.localId | A02270 | - |
dc.contributor.localId | A02457 | - |
dc.contributor.localId | A03456 | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J01813 | - |
dc.subject.keyword | Chemotherapy-induced leukopenia DA-3030 | - |
dc.subject.keyword | Efficacy | - |
dc.subject.keyword | 100microgram/m2 | - |
dc.contributor.alternativeName | Kim, Joo Hang | - |
dc.contributor.affiliatedAuthor | 김주항 | - |
dc.contributor.affiliatedAuthor | 노재경 | - |
dc.contributor.affiliatedAuthor | 라선영 | - |
dc.contributor.affiliatedAuthor | 안철우 | - |
dc.contributor.affiliatedAuthor | 유내춘 | - |
dc.contributor.affiliatedAuthor | 장윤수 | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.citation.volume | 29 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 886 | - |
dc.citation.endPage | 898 | - |
dc.identifier.bibliographicCitation | Journal of the Korean Cancer Association (대한암학회지), Vol.29(5) : 886-898, 1997 | - |
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