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ASCO 2014:DP方案联合同期放疗后继续DP方案不能延长Ⅲ期NSCLC患者PFS

2014-05-31 王静 译 医学论坛网

研究标题:不可手术Ⅲ期NSCLC同步放化疗后±多西他赛/顺铂巩固化疗的一项多中心Ⅲ期随机试验(CCheIN)(A multinational phase Ⅲ randomized trial with or without consolidation chemotherapy using docetaxel and cisplatin after concurrent chemora

研究标题:不可手术Ⅲ期NSCLC同步放化疗后±多西他赛/顺铂巩固化疗的一项多中心Ⅲ期随机试验(CCheIN)(A multinational phase Ⅲ randomized trial with or without consolidation chemotherapy using docetaxel and cisplatin after concurrent chemoradiation in inoperable stage Ⅲ non-small cell lung cancer (CCheIN).)

摘要号:# 7500

报告时间:2014年6月2日 9:45 AM-12:45 PM CDT(美国中部夏令时间)

报告者:韩国三星医学中心 Keunchil Park

Session Title:Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers

Session Type:Oral Abstract Session

背景: 对于不可手术的Ⅲ期NSCLC,目前推荐的治疗为同步放化疗(CCRT)。CCRT后继续巩固化疗的疗效有待进一步明确。该Ⅲ期研究的目的是明确多西他赛联合顺铂用于同期放化疗后继续巩固化疗的疗效。

方法: 不可手术的Ⅲ期NSCLC患者随机分为单纯放疗组和巩固治疗组(CCRT后继续巩固化疗)。N2或N3病变经PET或病理确诊。 CCRT方案:多西他赛20 mg/平方米/周,顺铂20 mg/平方米/周,连续6周,放疗剂量66 Gy/33 f。巩固治疗组之后进行3周期的DP方案化疗(D和P均为35 mg/平方米,第1,8天,每3周为1周期。)主要研究终点为PFS,次要终点包括OS、有效率、治疗失败的类型和安全性。计划入组434例。

结果: 自2005年10月至2011年4月,共入组437例患者。419例完成了同期放化疗(意向治疗人群:观察组208例,巩固治疗组211例),两组基线特征均衡。巩固治疗组,有142例(67%)接受了巩固治疗,其中95例(67%)完成了计划的3周期化疗。观察组中位PFS期8个月(95% CI 7.5~8.8) ,巩固治疗组为9.1个月(95% CI 7.9~10.9) ,P=0.38,两组中位OS期分别为20.6个月(95% CI 17.5~26.3) 和21.2个月(95% CI 17.7~24.7),P=0.48。目前该试验正在对组织和血液的肿瘤标志物做进一步探索性研究。

结论: 该研究结果显示DP方案每周一次联合同期放疗后,继续DP方案化疗并不能延长Ⅲ期NSCLC患者的PFS。

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    2015-01-26 quxin068
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    2015-04-03 zywlvao
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    2014-06-05 jklm09
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    2014-06-02 jeanqiuqiu

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