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安罗替尼III期研究ALTER0303数据写入《2018版CSCO肺癌指南》

2018-04-22 肿瘤资讯编辑部 肿瘤资讯

4月21日,2018年CSCO指南大会在南京顺利召开。肺癌作为近年来进展最快的瘤种之一,在新版《CSCO原发性肺癌诊疗指南》上,再次更新了众多研究进展。值得一提的是,由我国自主研发的国家1.1类新药,多靶点酪氨酸激酶抑制剂安罗替尼的III期研究ALTER0303数据写入《2018版CSCO原发性肺癌诊疗指南》。安罗替尼即将上市,有望填补我国晚期NSCLC三线治疗的空白,造福中国患者。

4月21日,2018年CSCO指南大会在南京顺利召开。肺癌作为近年来进展最快的瘤种之一,在新版《CSCO原发性肺癌诊疗指南》上,再次更新了众多研究进展。值得一提的是,由我国自主研发的国家1.1类新药,多靶点酪氨酸激酶抑制剂安罗替尼的III期研究ALTER0303数据写入《2018版CSCO原发性肺癌诊疗指南》。安罗替尼即将上市,有望填补我国晚期NSCLC三线治疗的空白,造福中国患者。

2018 CSCO原发性肺癌诊疗指南发布

由CSCO牵头,汇聚中国肺癌领域多学科专家编写的《CSCO原发性肺癌诊疗指南》于2016年4月首次推出,今年已经是第三版。CSCO指南在制定时兼顾到地区发展不平衡、药物和治疗措施的可及性以及肿瘤治疗的价值三方面,是目前最适合我国国情的指南,已经成为中国肺癌临床诊疗的重要指引。

中国晚期NSCLC三线治疗现状

根据患者是否携带驱动基因,晚期NSCLC可分为驱动基因阳性的NSCLC(包括EGFR突变,ALK或ROS1融合基因阳性等)和驱动基因阴性的NSCLC(可细分为鳞癌和非鳞癌)。

对于EGFR突变的晚期NSCLC,一线治疗首选EGFR TKI,耐药后可根据患者的耐药模式选择后续治疗,如为快速进展的患者,应进行T790M突变检测,T790M阳性患者可选用奥希替尼或含铂双药化疗,T790M阴性的患者可选择含铂双药化疗。EGFR突变的晚期NSCLC,若PS评分为0-2分,三线治疗推荐单药化疗。ALK或ROS1重排的患者,一线治疗首选ALK抑制剂克唑替尼,克唑替尼耐药后可根据患者的耐药模式进行选择,快速耐药的患者可以选择含铂双药化疗。对于ALK或ROS1融合基因阳性的晚期NSCLC的三线治疗,目前指南尚无标准推荐。

对于无驱动基因的晚期非鳞NSCLC,PS评分0-1分的患者,一线治疗可选用含铂双药化疗,或联合贝伐珠单抗治疗,PS评分2分的患者,可考虑单药化疗。二线治疗上,若PS评分为0-2分,推荐单药化疗;三线治疗尚无标准方案可选,推荐最佳支持治疗。对于无驱动基因的晚期鳞癌患者,治疗方案上大致相当,一线治疗可选用含铂双药化疗,二线治疗若患者PS评分为0-2分,推荐单药化疗;三线治疗无标准方案。

综上可知,目前对于晚期NSCLC的三线治疗,大多数患者无标准方案推荐。值得一提的是,近年来小分子酪氨酸激酶抑制剂在晚期NSCLC的三线治疗上崭露头角,特别是安罗替尼用于晚期NSCLC三线及以上治疗的III期临床研究ALTER0303取得了OS和PFS的双阳性结果,得到指南关注。

ALTER0303研究结果回顾

安罗替尼是一种口服的新型小分子多靶点TKI,可强效抑制VEGFR、PDGFR、FGFR和c-Kit等多个靶点,具有抗肿瘤血管生成和抑制肿瘤生长的双重作用。在2017年的ASCO和WCLC会议上,分别发布了安罗替尼三线及以上治疗晚期NSCLC的III期临床研究ALTER0303的主要研究结果和EGFR亚组分析结果。

ALTER0303研究共纳入了437例既往至少接受过两次系统性化疗方案治疗的IIIB/IV期NSCLC患者,随机接受安罗替尼(n=294)或安慰剂(n=143)治疗,直至疾病进展或不可耐受的毒性。结果显示,ALTER0303达到了主要终点,安罗替尼单药能够显著延长中位OS和PFS,OS延长3.3个月(9.6 vs 6.3个月; HR=0.68; 95%CI, 0.54-0.87; p=0.0018);PFS延长4.0个月(5.4 vs 1.4个月; HR=0.25; 95%CI, 0.19-0.31; p<0.0001)。在ORR(9.2% vs. 0.7%,p<0.0001)和DCR(81.0% vs. 37.1%,p<0.0001)等次要终点上,安罗替尼组也均显著优于对照组。EGFR亚组分析显示,EGFR敏感性突变阳性或阴性的患者都能从安罗替尼的治疗中获得OS和PFS的双重获益。此外,安罗替尼显示了良好的安全性,不良事件发生率与对照组相似。

安罗替尼将造福更多中国患者

ALTER0303研究证实,安罗替尼作为晚期NSCLC的三线治疗,能够带来OS和PFS双重获益,且安全性可控。目前,安罗替尼已进入CDE快速审批通道,即将上市,ALTER0303研究数据已写入《2018版CSCO肺癌指南》,期待未来安罗替尼改写肺癌三线治疗指南,填补中国晚期NSCLC三线治疗的空白。

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    2018-06-17 juliusluan78
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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Mon Apr 23 06:42:04 CST 2018, time=2018-04-23, status=1, ipAttribution=)]
    2018-06-11 shizhenshan
  4. 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Mon Apr 23 06:42:04 CST 2018, time=2018-04-23, status=1, ipAttribution=)]
    2018-04-26 衣带渐宽

    学习

    0

  5. 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Mon Apr 23 06:42:04 CST 2018, time=2018-04-23, status=1, ipAttribution=)]
    2018-04-26 jihuaijun1112

    学习学习学习

    0

  6. 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replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Mon Apr 23 06:42:04 CST 2018, time=2018-04-23, status=1, ipAttribution=)]
    2018-04-25 jihuaijun1112

    学习学习学习

    0

  7. 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  8. 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    2018-04-23 fangjing

    继续努力

    0

  9. 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    2018-04-23 12225669m29暂无昵称

    学习

    0

  10. 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    2018-04-23 三生有幸9135

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