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JCO:更新肺癌治疗指南!基因检测要做,免疫疗法被“写进”一线治疗

2017-08-18 佚名 生物探索

对于IV型非小细胞肺癌患者,应根据患者癌症的不同类型提供什么样的全身治疗方案?2017年8月14日,美国临床肿瘤协会(ASCO)于《临床肿瘤学杂志》(JCO)在线更新了临床实践指南,为我们提供了相关推荐。据悉,上一次更新还是在2015年,这些建议是基于患者已经做过EGFR/ALK/ROS1基因检测,同时免疫疗法也被“写进”了一线治疗。



对于IV型非小细胞肺癌患者,应根据患者癌症的不同类型提供什么样的全身治疗方案?

2017年8月14日,美国临床肿瘤协会(ASCO)于《临床肿瘤学杂志》(JCO)在线发布了“IV期非小细胞肺癌的系统性治疗:ASCO临床实践指南更新(Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update)”,对2015年发布的Ⅳ期非小细胞肺癌NSCLC)指南进行了更新。

据悉,指南专家组成员系统回顾了2014年2月至2016年12月的14项Ⅱ、Ⅲ期随机对照试验,并作出了以下重要推荐。

ASCO临床实践指南更新



指南问题:对于Ⅳ期非小细胞肺癌患者,应根据患者癌症的亚型提供什么样的全身治疗方案?

目标人群:Ⅳ期非小细胞肺癌患者。

目标读者:肿瘤护理提供者(包括初级保健医师、专科医生、护士、社会工作者和综合性多学科癌症护理小组的任何其他相关成员)、患者及其护理人员。

方法:召开了一次专家论坛,根据对医学文献的系统审查,制定最新的临床实践指南建议。

关键点:有关详细资料,请参见建议部分。●IV期NSCLC目前仍无法完全治愈。●不能仅仅根据年龄做化疗决策。

一线治疗



●体内无EGFR敏感突变、ALK或ROS1基因重排,且体能状态PS评分为0~1(及适宜的PS2)的非鳞状细胞癌患者:

○患者的PD-L1表达水平高(肿瘤比例评分[TPS]≥50%),在没有治疗禁忌的情况下,推荐单用派姆单抗(pembrolizumab)治疗(证据质量:高;推荐程度:强)。

○对于PD-L1表达较低(TPS<50%)的患者,临床医生应给予标准化疗,几种不同组合的细胞毒药物化疗方案均可被推荐(如果应用卡铂和紫杉醇,联用或不联用贝伐珠单抗),包括铂类为基础的化疗方案(证据质量:高;推荐程度:强),非铂类为基础的化疗方案(证据质量:中;推荐程度:弱)。

○推荐贝伐珠单抗(bevacizumab)联合培美曲塞与卡铂的证据不足。

○不推荐其他免疫检查点抑制剂、检查点抑制剂的联用或免疫检查点抑制剂联合化疗。

○PS评分为2的患者:可选择联合/单药化疗或单用姑息疗法(化疗[证据质量:中等;推荐程度:弱];姑息疗法[证据质量:中;推荐程度:强])。

●体内无EGFR敏感突变、ALK或ROS1基因重排,且PS 0~1(及适宜的PS2)的鳞状细胞癌患者:

○患者的PD-L1表达水平较高(TPS≥50%),在没有治疗禁忌的情况下,推荐单用派姆单抗(pembrolizumab)治疗(证据质量:高;推荐程度:强)。

○患者PD-L1表达较低(TPS<50%),临床医生应给予标准化疗(铂类为基础的化疗方案[证据质量:高;推荐程度:强];非铂类为基础的化疗方案[证据质量:低;推荐程度:弱])。

○不推荐其他免疫检查点抑制剂、检查点抑制剂联用或免疫检查点抑制剂联合化疗;

○PS评分为2的患者:可选择联合/单药化疗或单用姑息疗法(化疗[证据质量:中;推荐程度:弱];姑息疗法[证据质量:中;推荐程度:强])。

○对于顺铂和吉西他滨治疗的NSCLC鳞癌患者,指南专家组既不推荐也不反对在化疗基础上加用耐昔妥珠单抗(necitumumab)。

●EGFR敏感突变患者:推荐阿法替尼、厄洛替尼或吉非替尼(证据质量:高;推荐程度:每种药物都很强)。

●ALK基因重排患者:推荐克唑替尼(证据质量:中;推荐程度:中)。

●ROS1重排患者:推荐克唑替尼(类型:非正式共识;证据质量:低;推荐程度:弱)。

二线治疗



●体内无EGFR敏感突变、ALK或ROS1基因重排,且PS 0~1(及适宜的PS2)的患者:

○对于PD-L1表达水平较高(TPS≥1%),一线化疗治疗,之前未使用过免疫疗法的患者,在没有治疗禁忌的情况下,推荐单用纳武单抗(nivolumab)、派姆单抗(pembrolizumab)或阿替唑单抗(atezolizumab)治疗(证据质量:高;推荐程度:强)。

○PD-L1表达阴性或未知(TPS<1%)、一线化疗治疗且无治疗禁忌的患者,推荐纳武单抗(nivolumab)或阿替唑单抗(atezolizumab)治疗,以及各种组合的细胞毒化疗方案(证据质量:高;推荐程度:强)。

○不推荐其他免疫检查点抑制剂、检查点抑制剂联用或免疫检查点抑制剂联合化疗。

○对于一线免疫检查点抑制剂治疗的患者,临床医生应给予标准化疗(铂类为基础的化疗[证据质量:高;推荐程度:强];非铂类为基础的化疗[非正式共识;证据质量:低;推荐程度:强])。

○一线化疗后对免疫检查点抑制剂治疗有禁忌的患者,推荐多西他赛治疗(证据质量:中;推荐程度:中)。

○对于未接受过培美曲塞治疗的非鳞状细胞癌患者,推荐使用培美曲塞(证据质量:中;推荐程度:中)。

●有敏感性EGFR突变的患者:

○表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)一线治疗后疾病进展、且伴有T790M突变的患者,推荐奥希替尼(osimertinib)治疗(证据质量:高;推荐程度:强)。

-若未发生T790M突变者,推荐含铂双药化疗(类型:非正式共识;证据质量:低;推荐程度:强)。

○患者一线EGFR-TKI 治疗,若起初有反应,但随后发生孤立部位的缓慢/微少的疾病进展,EGFR-TKI联用针对孤立病灶的局部治疗是一种选择(类型:非正式共识;证据质量:不充分;推荐程度:弱)。

●ROS1重排患者:

○对于未接受过克唑替尼治疗的患者,推荐克唑替尼(非正式共识;证据质量:低;推荐程度:中)。

○若患者之前接受过克唑替尼治疗,推荐铂类为基础的化疗±贝伐珠单抗的二线治疗(非正式共识;证据质量:不充分;推荐程度:中)。

●BRAF突变患者:

○对于未接受过免疫检查点抑制剂治疗且PD-L1表达水平较高(TPS>1%)的患者,推荐阿替唑单抗(atezolizumab)、纳武单抗(nivolumab)或派姆单抗(pembrolizumab)(类型:非正式共识;证据质量:不充分;推荐程度:弱)。

○若患者之前接受过免疫检查点抑制剂治疗,单用达拉非尼(dabrafenib)或联用三线曲美替尼(trametinib)治疗也是一个选择(类型:非正式共识;证据质量:不充分;推荐程度:中)。

三线治疗:



●没有EGFR敏感突变或无ALK和ROS1基因重排、PS为0或1(以及适合的PS2)的非鳞癌患者、接受过化疗联合/不联合贝伐单抗和免疫检查点抑制剂治疗,可选择单药培美曲塞或多西紫杉醇(类型:非正式的共识;证据级别:低;推荐强度:强)。

●EGFR敏感性突变,接受过至少一种一线EGFR-TKI以及含铂化疗方案治疗的患者,还没有足够的数据证明免疫治疗优于化疗(培美曲塞或多西他赛[类型:非正式的共识;证据级别:不足;推荐强度:弱])。

四线治疗:



●患者和临床医生应考虑和讨论实验性疗法、临床试验和持续的最佳支持(姑息)治疗。

注意事项


注:所有的推荐是获益大于危害的。推荐都是基于证据的,除非另有说明。

ASCO坚信,癌症的临床试验对决定医疗决策和改善癌症护理至关重要,所有的患者都应该有机会参与。

划重点 :免疫疗法被“写进”一线治疗,建议是基于患者做过基因检测

更新的指南要点包括EGFR突变、ALK重排、ROS1重排阴性或状态未知,PD-L1高表达(TPS≥50%)的患者使用免疫治疗药物派姆单抗(pembrolizumab,即默沙东的Keytruda)作为一线治疗方案。

如果患者PD-L1低表达(TPS<50%),应提供标准化疗方案,主要考虑铂类联合用药方案。不推荐使用检查点抑制剂单药,检查点抑制剂联合或免疫治疗联合化疗。

在新修订的二线治疗建议对未接受免疫治疗的PD-L1高表达患者(TPS≥1%),使用纳武单抗(nivolumab,即百时美施贵宝的Opdivo)、派姆单抗(pembrolizumab,即默沙东的Keytruda)或阿替唑单抗(atezolizumab,即罗氏的Tecentriq)。如果PD-L1低表达(TPS<1%)或状态未知,推荐使用nivolumab、atezolizumab或化疗,不过指南未规范如何做出这些选择。

ASCO强调,这些建议是基于患者已经做过EGFR/ALK/ROS1基因检测;此外虽然免疫疗法可以为部分患者带来生存益处,但不是每个患者都能对其有反应。

ASCO专家组联合主席Nasser Hanna医生对媒体表示,肺癌治疗在过去几年中变得越来越复杂。该指南更新为肿瘤医生提供了工具,来选择最能使患者获益的疗法。

专家小组联合主席Gregory Masters医生则希望,患者能够依靠这份指南跟上疗效和耐受性最好的疗法,来帮助管理这种破坏性疾病;而医生则知道什么时候可使用靶向疗法或免疫疗法替代毒性更大的化疗,可以帮助提高患者的生活质量。

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createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqcAwLDVlsWdkjRvWfuiaXKZuQc7wBCmHM5Go3OacaDkO3Mib3VbbTzuNZCHEjqeHShX4dqVequotTw/0, createdBy=933a1954585, createdName=xufang111, createdTime=Sat Aug 19 06:42:03 CST 2017, time=2017-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234833, encodeId=fa0e23483325, content=未发生T790M突变者,推荐含铂双药化疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Fri Aug 18 21:31:22 CST 2017, time=2017-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234831, encodeId=d9b42348317b, content=(EGFR-TKI)一线治疗后疾病进展、且伴有T790M突变的患者,推荐奥希替尼(osimertinib), beContent=null, objectType=article, channel=null, level=null, likeNumber=78, 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  3. 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createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqcAwLDVlsWdkjRvWfuiaXKZuQc7wBCmHM5Go3OacaDkO3Mib3VbbTzuNZCHEjqeHShX4dqVequotTw/0, createdBy=933a1954585, createdName=xufang111, createdTime=Sat Aug 19 06:42:03 CST 2017, time=2017-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234833, encodeId=fa0e23483325, content=未发生T790M突变者,推荐含铂双药化疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Fri Aug 18 21:31:22 CST 2017, time=2017-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234831, encodeId=d9b42348317b, content=(EGFR-TKI)一线治疗后疾病进展、且伴有T790M突变的患者,推荐奥希替尼(osimertinib), beContent=null, objectType=article, channel=null, level=null, likeNumber=78, 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    2017-12-13 lidong40
  4. 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    2017-08-19 xufang111

    希望科学研究成果能早日转化至临床,精准医疗,造福患者

    0

  5. 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    2017-08-18 随梦飞扬

    未发生T790M突变者,推荐含铂双药化疗

    0

  6. 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    2017-08-18 随梦飞扬

    (EGFR-TKI)一线治疗后疾病进展、且伴有T790M突变的患者,推荐奥希替尼(osimertinib)

    0

  7. 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createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqcAwLDVlsWdkjRvWfuiaXKZuQc7wBCmHM5Go3OacaDkO3Mib3VbbTzuNZCHEjqeHShX4dqVequotTw/0, createdBy=933a1954585, createdName=xufang111, createdTime=Sat Aug 19 06:42:03 CST 2017, time=2017-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234833, encodeId=fa0e23483325, content=未发生T790M突变者,推荐含铂双药化疗, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/02/7354b3539aae6a0ccb1e0fff04c12084.jpg, createdBy=205b1984786, createdName=随梦飞扬, createdTime=Fri Aug 18 21:31:22 CST 2017, time=2017-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=234831, encodeId=d9b42348317b, content=(EGFR-TKI)一线治疗后疾病进展、且伴有T790M突变的患者,推荐奥希替尼(osimertinib), beContent=null, objectType=article, channel=null, level=null, likeNumber=78, 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    2017-08-18 随梦飞扬

    一线化疗后对免疫检查点抑制剂治疗有禁忌的患者,推荐多西他赛治疗

    0

  8. 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    2017-08-18 随梦飞扬

    对于一线免疫检查点抑制剂治疗的患者,临床医生应给予标准化疗(铂类为基础的化疗[

    0

  9. 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    2017-08-18 随梦飞扬

    PD-L1表达阴性或未知(TPS<1%)、一线化疗治疗且无治疗禁忌的患者,推荐纳武单抗(nivolumab)或阿替唑单抗(atezolizumab)治疗,以及各种组合的细胞毒化疗方案

    0

  10. 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    2017-08-18 随梦飞扬

    PD-L1表达水平较高(TPS≥1%),一线化疗治疗,之前未使用过免疫疗法的患者,在没有治疗禁忌的情况下,推荐单用纳武单抗(nivolumab)、派姆单抗(pembrolizumab)或阿替唑单抗(atezolizumab)

    0

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Front Pharmacol:在铂类治疗的转移性非小细胞肺癌患者中添加中药,能提高患者生活质量

背景:根据临床经验,将传统中药添加到铂类化疗(PBT)中能改善转移性非小细胞肺癌患者的生活质量,但该临床经验仍缺乏前瞻性验证。患者与方法:研究人员根据临床反应评价将中药加入以PBT疗法后的影响。为了安全起见,研究过程中每个小组至少招收了28名病人。在一项前瞻性随机对照试验,61例特定的IIIB-IV期肺癌患者(PBT+安慰剂组,n = 32;PBT+中药组,n = 29)确定为连续患者,这些患者符

Cancer Cell:了解肺癌,这个血液指标很关键!

荷兰的研究人员设计了不同的液体活检方法。通过检测血液循环血小板(也称为血栓细胞)吸收的肿瘤RNA,他们的测试(称为thromboSeq)不是在血液中寻找癌症DNA或其他生物标志物的证据,而是可以以接近90%的准确度诊断非小细胞肺癌。非小细胞肺癌占肺癌的绝大多数。该研究在8月14日刊登在癌症细胞杂志上。

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