索拉非尼的高级黑素瘤:二期随机中止试验分析。

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艾森T, Ahmad T, Flaherty KT,戈尔M,凯,Marais R, Gibbens我,哈科特年代,詹姆斯M, Schuchter LM,内桑森KL,夏C, Simantov R,施瓦茨B, Poulin-Costello M O 'Dwyer PJ, Ratain乔丹

索拉非尼的高级黑素瘤:二期随机中止试验分析。

Br J癌症。2006年9月4日,95 (5):581 - 6。Epub 2006 8月1。

PubMed ID

16880785 (在PubMed

]

文摘

索拉非尼的影响——口服multikinase抑制剂针对肿瘤和肿瘤脉管系统——在晚期黑色素瘤患者进行评估参加一个大型multidisease二期随机中止试验(RDT)。登记患者接受为期12周的争论的索拉非尼400毫克每天两次(b.i.d)。改变循环水肿瘤患者从基线测量< 25%被随机索拉非尼或安慰剂进一步12周(24周)。> = 25%患者肿瘤收缩试车后继续非盲索拉非尼,而那些有> = 25%肿瘤生长停止治疗。这种分析关注二级RDT终点:循环水肿瘤12周后测量基线的变化和整体肿瘤反应(标准)在24周,无进展生存(PFS),安全性和生物标志物(BRAF、喀斯特和国家管制当局方面突变状况)。37的黑色素瘤患者在试车阶段,34岁可评价的反应:有> = 25%的肿瘤收缩和保持开放的索拉非尼;6(16%)< 25%的肿瘤生长和随机(安慰剂,n = 3;索拉非尼,n = 3);27有> = 25%的肿瘤生长和停止。所有三个随机索拉非尼患者24周的进展; one remained on sorafenib for symptomatic relief. All three placebo patients progressed by week-24 and were re-started on sorafenib; one experienced disease re-stabilisation. Overall, the confirmed best responses for each of the 37 melanoma patients who received sorafenib were 19% stable disease (SD) (ie n=1 open-label; n=6 randomised), 62% (n=23) progressive disease (PD) and 19% (n=7) unevaluable. The overall median PFS was 11 weeks. The six randomised patients with SD had overall PFS values ranging from 16 to 34 weeks. The most common drug-related adverse events were dermatological (eg rash/desquamation, 51%; hand-foot skin reaction, 35%). There was no relationship between V600E BRAF status and disease stability. DNA was extracted from the biopsies of 17/22 patients. Six had V600E-positive tumours (n=4 had PD; n=1 had SD; n=1 unevaluable for response), and 11 had tumours containing wild-type BRAF (n=9 PD; n=1 SD; n=1 unevaluable for response). In conclusion, sorafenib is well tolerated but has little or no antitumour activity in advanced melanoma patients as a single agent at the dose evaluated (400 mg b.i.d.). Ongoing trials in advanced melanoma are evaluating sorafenib combination therapies.

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药物靶点

药物	目标	类	生物	药理作用	行动
索拉非尼	丝氨酸/ threonine-protein激酶b - raf	蛋白质	人类	是的	抑制剂	细节