二期试验的伊马替尼(ST1571)患者c - kit表达小细胞肺癌复发:CALGB NCCTG研究。

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Dy门将,米勒AA, Mandrekar SJ,奥布里MC,兰登RM Jr,莫顿射频,席尔德SE,小杰特,Adjei AA

二期试验的伊马替尼(ST1571)患者c - kit表达小细胞肺癌复发:CALGB NCCTG研究。

安11月杂志。2005;16 (11):1811 - 6。Epub 2005年8月8日。

PubMed ID
16087693 (在PubMed
]
文摘

背景:本研究的目的是评价甲磺酸伊马替尼对复发患者的临床活动和耐火c-kit-expressing小细胞肺癌。c-kit-expressing SCLC患者患者和方法:通过免疫组织化学方法(> = 1 +)在两组。手臂一个包括患者疾病进展< 3个月和手臂B包括患者疾病进展> = 3个月后,之前的治疗。伊马替尼是服用的剂量400毫克b.i.d.连续28天的周期长度。单级西蒙设计与计划临时分析被用来评估16周进展自由率在每个手臂。结果:共有29个可评价的患者进入研究(七在手臂,平均年龄68;22在臂B,平均年龄64.5)。平均数量的治疗周期是一双手。级3 + non-hematologic不良事件被认为在15(52%)患者有恶心、呕吐、呼吸困难、乏力、厌食和脱水每个发生在至少10%的患者。中位数是3.9和5.3个月,中位生存时间为武器进程1和1.1个月A和B,分别。 Enrollment to arm A was temporarily suspended prior to reaching interim analysis due to striking early disease progression (29%), early deaths (29%) and patient refusal (42%). No objective responses and no confirmed stable disease > or =6 weeks were seen in either arm. Accrual was permanently terminated to both arms as only one patient was progression-free at 16 weeks. CONCLUSION: Imatinib failed to demonstrate any clinical activity in spite of patient selection for c-kit-expressing SCLC. Our results strengthen the collective evidence that prediction of efficacy of novel therapeutic agents based on target expression, rather than pathway activation (for example, through activating mutations), may not be a valid paradigm for drug development.

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药物靶点
药物 目标 生物 药理作用 行动
伊马替尼 桅杆/干细胞生长因子受体工具包 蛋白质 人类
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