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ASCO 2014:预防性颅脑照射具高危脑转移风险的IIIA N2期NSCLC可延长患者生存

2014-05-31 刘揆亮 译 医学论坛网

摘要号:#7508 第一作者:王思愚,中山大学附属肿瘤医院胸外科 充分切除并辅助化疗后具有高危脑转移风险的IIIA N2期非小细胞肺癌患者中预防性颅脑照射与观察进行比较的随机试验 背景:预防性颅脑照射(PCI)明显降低非小细胞肺癌(NSCLC)患者脑转移的发生率,不过对于生存的影响不明确。之前我们建立了一项预测局部进展期NSCLC患者发生脑转移危险的数学模型。本研究的目的是在已切除病变并接受

摘要号:#7508

第一作者:王思愚,中山大学附属肿瘤医院胸外科

充分切除并辅助化疗后具有高危脑转移风险的IIIA N2期非小细胞肺癌患者中预防性颅脑照射与观察进行比较的随机试验

背景:预防性颅脑照射(PCI)明显降低非小细胞肺癌(NSCLC)患者脑转移的发生率,不过对于生存的影响不明确。之前我们建立了一项预测局部进展期NSCLC患者发生脑转移危险的数学模型。本研究的目的是在已切除病变并接受辅助化疗,具有脑转移高危因素的IIIA N2期NSCLC患者中评价PCI是否可改善生存。

方法:这项开放性随机研究中,对于患IIIA N2期NSCLC,病变已完全切除,没有复发,接受了术后辅助化疗,具有脑转移高危因素的患者随机安排接受PCI (30 Gy ,分10次照射)或观察处理。主要终点为无病生存期(DFS)。次要终点包括脑转移发生率、总体生存(OS)和不良反应。 

结果:2005年1月 至 2009年1月, 156名符合标准的患者接受随机分配(PCI组81名,对照组75名)。本研究由于受试者入组缓慢而提前中止。PCI组相比于对照组明显延长了DFS,中位DFS分别为28.5 个月和 21.2个月(危险比[HR] 0.67,95%可信区间 [CI] 0.46-0.98,P=0.037)。 PCI组3年和5年DFS 分别为42.0% 和26.1%,观察组为29.8% 和18.5%。PCI与脑转移危险下降相关(5年脑部复发率13.6% 与41.3%,优势比0.223,95% CI 0.102-0.489,P<0.001)。PCI组中位OS 31.2 个月,对照组为27.4个月(HR, 0.81; 95% CI, 0.56-1.16; P=0.310)。 PCI组3年和5年 OS分别为44.5%和 27.4%,观察组为38.7%和22.8% 。而PCI组主要不良反应为头痛、恶心/呕吐和乏力,症状大多轻微。

结论:病变充分切除及辅助化疗后具有高危脑转移风险的IIIA N2 NSCLC患者中,PCI延长了 DFS,降低了脑转移发生率。

研究链接:A randomized trial of prophylactic cranial irradiation versus observation in patients with fully resected stage IIIA N2 non-small cell lung cancer and high risk of cerebral metastases after adjuvant chemotherapy. (Abstract 7508)

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    2014-06-24 quxin068
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    2015-01-22 juliusluan78
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