摘要
目的:评价国产抗癌新药阿托氟啶(atofluding,ATFU)对胃癌、大肠癌、食管癌及肝癌的临床疗效、不良反应及对免疫功能的影响。方法:多中心、开放、非随机单药临床研究,根据该药Ⅰ期临床研究结果,给予ATFU单药400mg口服,每日3次犤750mg·(m2·d)-1犦连用4-8周。第4周结束时评价疗效,完全缓解、部分缓解及无变化者继续用药至8周,病情进展者立即停药。结果:100例可评价疗效的患者中,CR3例、PR22例,总有效率22.5%,胃癌、大肠癌、食管癌及肝癌的有效率分别为26.7%、33.3%、30.0%和5.0%。ATFU的血液学不良反应轻微,Ⅲ-Ⅳ度白细胞减少仅占2%,非血液学不良反应包括恶心、呕吐、便秘、脱发、肝功能损害、腹泻及腹痛,大多为Ⅰ-Ⅱ度,可耐受。疗前、疗后免疫学指标测定表明,ATFU对免疫功能无影响。结论:国产抗癌新药ATFU对胃癌、大肠癌及食管癌疗效肯定、毒性轻、无免疫抑制作用,口服剂型使用方便,是一个有价值及治疗前景的抗癌新药。
Objective: To evaluate the efficacy, toxicity, and immunological change of a new anticancer drug atofloding (ATFU) in the patients with advanced digestive tract cancer. Method: A multiple center of clinical study was performed.The patients were treated with ATFU 400 mg,oral,Tid [750 mg·m2·d)-1] according to the results of Phase Ⅰ clinical trail. After a period of 4 weeks, unless disease progresses treatment should be continued until 8th week. Results: Among 100 evaluable cases, 3CR and 22PR were achieved with overall response rate of 22.5%. The response rate to cancers of stomach,colorectal,esophagus and liver was 26.1%, 33.3%, 30.0%, and 5.0%, respectively. Hematologic toxicities were mild with only 2% cases developed Greed Ⅲ leucopenia. Non hematologic toxicities included nausea, vomiting, constipation, loss hair, liver function lesion, diarrhea and abdominal pain, but most of them was Grade Ⅰ-Ⅱ. No immunosuppress was observed among 97 cases. Conclusion: ATFU is effective in advanced stomach cancer, colorectal cancer, and esophagus cancer with mild toxicity and no immunosuppress. Hereafter, AFTU has proved to be valuable and demonstrate promising prospect in clinical treatment.
出处
《癌症》
SCIE
CAS
CSCD
北大核心
2001年第12期1387-1390,共4页
Chinese Journal of Cancer
