摘要
背景与目的:华蟾素目前广泛应用于肿瘤的治疗中,由于在80年代上市,未进行临床Ⅰ期研究,无法确定其最大耐受剂量。因此本文旨在观察华蟾素治疗肝细胞癌、肺癌和胰腺癌的最大耐受剂量和不良反应,同时评价治疗疗效。方法:Ⅲ、Ⅳ期肝细胞癌、非小细胞肺癌和胰腺癌接受华蟾素治疗,采用静脉滴注,连续14 d,21 d为一疗程。如果没有出现剂量限制性毒性,治疗将持续2个疗程。剂量递增的方案为:10、20、40、60、90和120 m l/(m2.d)。结果:入组15例患者(每个剂量组为3例)中,11例为肝癌,2例胰腺癌和2例肺癌。第五剂量组结束时没有发现剂量限制性毒性(DLT)。其中14例患者可评价疗效,6例(42.9%)为SD,8例(57.1%)为PD。在第一剂量组中,1例肝癌患者肿瘤缩小20%并维持11个月。结论:本研究最高剂量达到常规剂量的8倍,尚未出现剂量限制性毒性。部分患者获得了肿瘤缩小或稳定的疗效。
Background and purpose： Huachansu has been widely used to treat cancer in China. But maximum tolerated dose（MTD） of huachansu is still not well defined. The purpose of this study was to conduct a Phase Ⅰ study to determine the MTD of huachansu in the treatment of patients with hepatocellular carcinoma, non-small cell lung or pancreatic cancer. Toxic profile and efficacy of huachansu were also assessed qualitatively. Methods： Haachansu was intravenously administered to patients with stage Ⅲ/Ⅳ hepatocellular carcinoma, non-small cell lung cancer, or pancreatic cancer. Each cycle consisted of daily huachansu for 14 days with an interval of 7 days between two cycles. 2 or more cycles were delivered to the patients if no severe adverse event occurred. The planned close escalation schedule for huachansu was as follows, 10, 20, 40, 60, 90 and 120 ml/（m^2·d）. Results： Fifteen patients （3 at each level） have been recruited to the study （11 with hepatocellular carcinoma, 2 with pancreatic cancer, and 2 with lung cancer）. There were no dose limiting toxicities found after dose level 5. Among all these patients, the efficacy in 14 patients could be valued, in which, 6 were SD （42.9%）, 8 were PD（57.1%）. At dose level 1, there was one patient with hepatocellular carcinoma achieving a 20% reduction in tumor mass that lasted 11 months, 6 of 15（42.9%） patients with stable disease and 8 of 15（57.1% ） with progress disease after the treatment. Conclusions： To date, dose limiting toxicity has not been seen with doses up to eight times higher than that typically used before. Of interest, several patients had prolonged stable disease or minor tumor shrinkage.
出处
《中国癌症杂志》
CAS
CSCD
2007年第5期376-379,共4页
China Oncology
基金
美国NCIR21(CA108084)项目
科技部国际合作重点项目(2005DFA30130)资助
关键词
华蟾素
Ⅰ期临床
肝癌
非小细胞肺癌
胰腺癌
huachansu
phase Ⅰ clinical trial
hepatocellular carcinoma
non-small cell lung cancer
pancreatic cancer
