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棘霉素(NSC 526417)的I期试验,一种双功能嵌入剂,通过24小时持续输注给药。

Phase I trial of echinomycin (NSC 526417), a bifunctional intercalating agent, administered by 24-hour continuous infusion.

作者信息

Kuhn J G, Von Hoff D D, Hersh M, Melink T, Clark G M, Weiss G R, Coltman C A

机构信息

Department of Medicine, University of Texas Health Science Center, San Antonio 78284-7765.

出版信息

Eur J Cancer Clin Oncol. 1989 May;25(5):797-803. doi: 10.1016/0277-5379(89)90123-5.

DOI:10.1016/0277-5379(89)90123-5
PMID:2737217
Abstract

Echinomycin was administered to 43 patients with advanced cancer in escalating doses ranging from 60 to 2128 mcg/m2. The dose-limiting toxicity of echinomycin administered as a 24-h continuous infusion every 28 days was nausea and vomiting beginning at the end of the 24 h infusion and lasting from 3 to 8 days. Other toxicities included sporadic thrombocytopenia and biochemical evidence of liver dysfunction characterized by elevations in SGOT. Peripheral vein phlebitis was noted in 100% of patients, and watery diarrhea of 24-48-h duration was noted in 7% of patients. The maximally tolerated dose of echinomycin was 2128 mcg/m2. The recommended dose for phase II trials utilizing the 24-h continuous infusion schedule is 1600 mcg/m2 repeated every 28 days with pretreatment antiemetics.

摘要

对43例晚期癌症患者给予不同剂量递增的棘霉素,剂量范围为60至2128微克/平方米。每28天进行一次24小时持续输注的棘霉素的剂量限制性毒性是恶心和呕吐,始于24小时输注结束时,持续3至8天。其他毒性包括偶发性血小板减少症以及以谷草转氨酶升高为特征的肝功能障碍的生化证据。100%的患者出现外周静脉炎,7%的患者出现持续24至48小时的水样腹泻。棘霉素的最大耐受剂量为2128微克/平方米。采用24小时持续输注方案进行II期试验的推荐剂量为1600微克/平方米,每28天重复一次,并在预处理时使用止吐药。

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