非小细胞肺癌,术后放疗系列研究汇总
非小细胞肺癌,放疗系列研究汇总(不可手术Ⅲ期)
全文概要
术后病理N分期,N0-1
1. ANITA研究:pN1 5年OS降低,pN2 5年OS获益
2. 一项META分析:I期/II期,不需进行术后放疗
术后病理N分期,N2(有争议)
3. Corso等研究、Urban等研究、Mikell等研究、Robinson等研究、另一项Meta分析:pN2,术后放疗生存获益
4. Wisnivesky等研究:pN2,老年患者术后放疗不能获益
5. 一项Meta分析:采用直线加速器放疗生存获益
6. 一项回顾性研究:多站N2,术后放疗生存获益
7. Lung ART研究:PORT没有显著改善IIIAN2期患者的生存获益,并增加心肺毒性
1998年[2]术后放疗荟萃分析试验组纳入了9项随机试验共2,128例NSCLC患者,旨在对比单纯手术和手术联合术后放疗的疗效。其中I期NSCLC患者562例,II期718例。结果发现,与单纯手术组相比,手术联合术后放疗组死亡风险升高21%(HR=1.21, 95%CI: 1.08-1.34, P=0.001),2年生存率 由55%下降到48%。手术联合术后放疗组2年无病生存率也下降4%(HR=1.13, 95%CI:1.02-1.26, P=0.018)。亚组分析显示这种不利影响主要体现在I期/II期NSCLC患者。
2005年[3]该试验组更新了荟萃分析结果,纳入10项随机临床试 验共计2,232例NSCLC患者,但结果与之前报道一致,与单纯手术组相比,手术联合术后放疗组无论是OS(HR=1.18, P=0.002)还是DFS(HR=1.10, P=0.06)均差于单纯手术组。与前述研究一致,这种不利影响仍然主要体现在I期/II期 NSCLC患者。
2013年[4]该试验组再次更新了荟萃分析结果,纳入11项随机临床试验共计2,343例NSCLC患者,但结果与之前报道一致,与单纯手术组相比,手术联合术后放疗组无论是OS(HR=1.18, 95%CI:1.07-1.31, P=0.001)还是DFS(HR=1.10, 95%CI: 1.099-1.21, P=0.06)均差于单纯手术组。这种不利影响仍然主要体现在I期/ II 期NSCLC患者。
Lung ART研究[15]:一项随机III期临床研究,旨在探索术后适形放疗(PORT)对完全性手术切除的N2期NSCLC患者的疗效和安全性。研究共纳入了501位患者,随机分配至PORT组(n=252)和对照组(不接受PORT,n=249)。患者中位年龄为61岁,66%为男性,73%为腺癌,96%之前接受过辅助化疗。主要终点是无病生存期(DFS),次要终点包括总生存期(OS)、复发模式、局部复发、出现第二肿瘤和治疗相关毒性等。
DFS
OS
死亡原因
参考文献
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