Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer.
Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer.
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DOI：
10.1002/cncr.24602
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发表时间：
2009-11-15
期刊：
影响因子：
6.2
通讯作者：
Kurzrock, Razelle
中科院分区：
文献类型：
--
作者：
Meng, Zhiqiang;Yang, Peiying;Shen, Yehua;Bei, Wenying;Zhang, Ying;Ge, Yongqian;Newman, Robert A.;Cohen, Lorenzo;Liu, Luming;Thornton, Bob;Chang, David Z.;Liao, Zongxing;Kurzrock, Razelle
关键词：
华蟾素是从中华大蟾蜍（Bufo bufo gargarizans Cantor）或黑纹蟾蜍（B.melanotictus Schneider）的皮肤腺中提取的干蟾毒中提取的一种中药，在中国已被用于治疗各种癌症。我们进行了一项初步研究，采用I期试验设计，华蟾素在晚期癌症患者。华蟾素静脉滴注14 d，停药7 d，1个周期。在无显著不良事件或疾病进展的情况下，治疗持续超过2个周期。华产素剂量（mL/ m2）递增如下，每个队列3例患者：10（水平1）、20（水平2）、40（水平3）、60（水平4）和90（水平5）mL/m2。15例患者（肝细胞癌，N = 11;非小细胞肺癌，N = 2;胰腺癌，N = 2）入组试验，未发现剂量限制性毒性（DLT），11例患者未发生大于I级的药物相关毒性。6例（40%）患者病情稳定（中位持续时间= 6.0个月;范围3.5 - 11.1个月）。其中1例患者（肝细胞癌）消退20%（持续时间= 11个月）（剂量水平1）。病情稳定患者的生活质量得到改善。血浆蟾蜍灵浓度在2小时输注结束时达到最高水平，并与给药量成比例（0.81-3.38，ng/mL）。在使用剂量高达中国通常使用剂量八倍的华产素时，没有观察到任何DLT。6例患者的病情长期稳定或肿瘤轻微缩小。
Huachansu, a Chinese medicine that comes from dried toad venom from the skin glands of Bufo bufo gargarizans Cantor or B.melanotictus Schneider, has been used in the treatment of various cancers in China. We conducted a pilot study, using a phase I trial design, of Huachansu in patients with advanced cancer. Huachansu was administered intravenously for 14 days followed by 7 days off (1 cycle). Without significant adverse events or progressive disease, treatment continued beyond 2 cycles. The dose of Huachansu (in mL/ m2) was escalated as follows with three patients per cohort: 10 (level 1), 20 (level 2), 40 (level 3), 60 (level 4), and 90 (level 5) mL/m2. Fifteen patients (hepatocellular cancer, N = 11; non-small cell lung cancer, N = 2; pancreatic cancer, N = 2) were enrolled in the trial and no dose limiting toxicities (DLT) were found. Eleven patients had no drug-related toxicity greater than grade I. Six (40%) had stable disease (median duration = 6.0 months; range 3.5 to 11.1 months). One of these patients (with hepatocellular cancer) had 20% regression (duration = 11 months) (dose level 1). Quality of life improved for patients with stable disease. Plasma bufalin concentration reached maximal levels at the end of the 2-hr infusion and was propotional to the amount of drug being administered (0.81-3.38, ng/mL). No DLT was observed with the use of Huachansu at doses up to eight times higher than typically used in China. Six patients had prolonged stable disease or minor tumor shrinkage.
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