P K Lillis, T D Brown, K Beougher, J Koeller, S G Marcus, D D Von Hoff
{"title":"Phase II trial of recombinant beta interferon in advanced colorectal cancer.","authors":"P K Lillis, T D Brown, K Beougher, J Koeller, S G Marcus, D D Von Hoff","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Betaseron is a genetically altered recombinant beta interferon with in vitro properties equivalent to those of native beta interferon. Nineteen patients with measurable advanced colorectal carcinoma who had no previous chemotherapy were given 30 X 10(6) IU Betaseron by iv push on Days 1-5 and 8-12 of each 28-day cycle. One of 17 evaluable patients had a complete response after nine courses of treatment which has been sustained greater than 9 months. The overall response rate was 6% (95% confidence limits, 0%-18%). Treatment was well tolerated with toxic effects consisting of fever, flu-like symptoms, nausea and vomiting, and transient mild granulocytopenia and liver function abnormalities. All toxic effects were World Health Organization (WHO) grade less than or equal to 2. No interferon neutralizing antibody activity was detected. Phase I and preclinical data support further investigation of Betaseron with dose escalation to tolerance for individual patients, as well as investigation of concomitant therapy with 5-fluorouracil, in an attempt to improve the observed response rate in colorectal cancer.</p>","PeriodicalId":9581,"journal":{"name":"Cancer treatment reports","volume":"71 10","pages":"965-7"},"PeriodicalIF":0.0000,"publicationDate":"1987-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer treatment reports","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Betaseron is a genetically altered recombinant beta interferon with in vitro properties equivalent to those of native beta interferon. Nineteen patients with measurable advanced colorectal carcinoma who had no previous chemotherapy were given 30 X 10(6) IU Betaseron by iv push on Days 1-5 and 8-12 of each 28-day cycle. One of 17 evaluable patients had a complete response after nine courses of treatment which has been sustained greater than 9 months. The overall response rate was 6% (95% confidence limits, 0%-18%). Treatment was well tolerated with toxic effects consisting of fever, flu-like symptoms, nausea and vomiting, and transient mild granulocytopenia and liver function abnormalities. All toxic effects were World Health Organization (WHO) grade less than or equal to 2. No interferon neutralizing antibody activity was detected. Phase I and preclinical data support further investigation of Betaseron with dose escalation to tolerance for individual patients, as well as investigation of concomitant therapy with 5-fluorouracil, in an attempt to improve the observed response rate in colorectal cancer.
Betaseron是一种转基因重组干扰素，具有与天然干扰素相同的体外特性。19例可测量的晚期结直肠癌患者既往未接受化疗，在每28天周期的第1-5天和第8-12天静脉推注30 X 10(6) IU倍他司龙。17例可评估的患者中有1例在持续9个月以上的9个疗程治疗后完全缓解。总有效率为6%(95%置信限，0%-18%)。治疗耐受性良好，毒性反应包括发烧、流感样症状、恶心和呕吐、短暂的轻度粒细胞减少和肝功能异常。所有毒性作用均为世界卫生组织(WHO) 2级以下或等于2级。未检测到干扰素中和抗体活性。I期和临床前数据支持进一步研究倍他司龙对个体患者的剂量递增至耐受性，以及研究5-氟尿嘧啶联合治疗，以提高观察到的结直肠癌应答率。
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
