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尼莫司汀在荷瘤犬中的I期剂量递增研究。

Phase I dose-escalation study of nimustine in tumor-bearing dogs.

作者信息

Takahashi Masashi, Goto-Koshino Yuko, Fukushima Kenjiro, Kanemoto Hideyuki, Nakashima Ko, Fujino Yasuhito, Ohno Koichi, Endo Yasuyuki, Tsujimoto Hajime

机构信息

Department of Veterinary Internal Medicine, Graduate School of Agricultural and Life Sciences, The University of Tokyo, 1-1-1, Yayoi, Bunkyo-ku, Tokyo 113-8657, Japan.

出版信息

J Vet Med Sci. 2014 Jun;76(6):895-9. doi: 10.1292/jvms.13-0345. Epub 2014 Feb 10.

DOI:10.1292/jvms.13-0345
PMID:24521794
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4108775/
Abstract

Nimustine (ACNU) is an alkylating agent of the nitrosourea and can be an antineoplastic agent in dogs. But, there has been no report on its dose-limiting toxicity (DLT) in dogs. This study was a phase I dose-escalation clinical trial to determine the maximum tolerated dose (MTD) and DLT of ACNU in tumor-bearing dogs. The starting dosage was 25 mg/m(2), and subsequent dosages were administered in increments of 5 mg/m(2) in cohort of 3 dogs. Eight dogs were included, the MTD was determined to be 25 mg/m(2), DLT was neutropenia, and the optimal interval was considered to be 21 days. The data herein provide a basis for the subsequent phase II trial of ACNU in dogs.

摘要

尼莫司汀(ACNU)是一种亚硝基脲类烷化剂,可作为犬类的抗肿瘤药物。但是,关于其在犬类中的剂量限制性毒性(DLT)尚无报道。本研究是一项I期剂量递增临床试验,旨在确定ACNU在荷瘤犬中的最大耐受剂量(MTD)和DLT。起始剂量为25mg/m²,随后以5mg/m²的增量在每组3只犬中给药。纳入8只犬,确定MTD为25mg/m²,DLT为中性粒细胞减少,最佳间隔时间为21天。本文的数据为后续ACNU在犬类中的II期试验提供了依据。