Initial clinical studies with bruceantin.
Initial clinical studies with bruceantin.
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布鲁斯汀的初步临床研究。
DOI：
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发表时间：
1979
期刊：
影响因子：
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通讯作者：
E. Freireich
中科院分区：
文献类型：
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作者：
A. Bedikian;M. Valdivieso;G. Bodey;W. Murphy;E. Freireich
对66例不同类型的晚期实体瘤患者进行了布鲁氏菌毒素的I期临床研究，以评价其毒性和疗效。初始剂量为0.2 mg/m2/天x 5天，以2周间隔重复，逐渐增加至最大剂量4.5 mg/m2/天。低血压是剂量限制性毒性效应;具有延迟性、累积性，且更常发生在治疗前肝功能异常的患者中。恶心、呕吐和发热在较高剂量下很常见，在一些患者中观察到腹泻、口腔炎、脱发、感觉异常和皮疹。在高剂量下，布鲁氏菌毒素的血液学毒性为中度，主要表现为血小板减少;在肝肾功能异常的患者中，毒性更为严重。未观察到客观肿瘤消退。对于II期研究，推荐的布鲁氏菌毒素剂量为3.5 mg/m2/天× 5天。
A phase I clinical study of bruceantin was conducted in 66 patients with various types of advanced solid tumors to evaluate its toxicity and efficacy. The initial dose of 0.2 mg/m2/day x 5 days repeated at 2-week intervals was progressively increased to a maximum dose of 4.5 mg/m2/day. Hypotension was the dose-limiting toxic effect; it was delayed, cumulative, and occurred more often in patients with abnormal pretreatment liver function. Nausea, vomiting, and fever were common at higher doses, and diarrhea, stomatitis, alopecia, paresthesia, and rash were observed in some patients. The hematologic toxicity of bruceantin was moderate at high doses and was manifested mainly as thrombocytopenia; it was more severe in patients with abnormal hepatic and renal functions. No objective tumor regressions were observed. The recommended dose of bruceantin is 3.5 mg/m2/day x 5 days for phase II studies.