JCO:Brigatinib二线治疗ALK阳性NSCLC有力量

2017-05-14 wrangx 肿瘤资讯

JCO近期在线发表Brigatinib二线治疗克唑替尼耐药ALK阳性NSCLC的随机、非对比、双臂、多中心Ⅱ期ALTA研究,180mg Brigatinib(90mg起始)整体ORR54%,颅内ORR64%,中位PFS12.8个月,1年生存率80%,3级以上不良事件发生率低。

JCO近期在线发表Brigatinib二线治疗克唑替尼耐药ALK阳性NSCLC的随机、非对比、双臂、多中心Ⅱ期ALTA研究,180mg Brigatinib(90mg起始)整体ORR54%,颅内ORR64%,中位PFS12.8个月,1年生存率80%,3级以上不良事件发生率低。

背景

ALK阳性NSCLC占5%,克唑替尼有效率61%~74%,中位PFS8~11个月,但不可避免出现获得性耐药和/或颅内进展,色瑞替尼和艾乐替尼已批准用于克唑替尼耐药的ALK阳性NSCLC,中位PFS分别为5.7~6.9个月和8.1~8.9个月。

Brigatinib对多种ALK耐药突变有效,包括色瑞替尼和艾乐替尼治疗无效的G1202R突变。在Ⅰ/Ⅱ期研究中,Brigatinib二线治疗ORR62%,PFS12.9个月。在剂量递增和Ⅱ期拓展研究中,部分使用180mg剂量患者,在起始24~48小时内出现中到重度肺毒性。故本研究使用2个剂量,90mg剂量组和180mg剂量组(起始7天90mg),目的是减少肺毒性同时增加剂量强度。

方法

开放标签、随机、多中心、非对比、双臂的Ⅱ期研究。

主要入排标准:年龄≥18岁;克唑替尼治疗进展的局部晚期或转移性ALK阳性NSCLC;至少一处可评估病灶(RECIST标准);PS评分≤2分;既往未接受过除克唑替尼外其他ALK抑制剂治疗;排除既往或现存间质性肺炎或药物相关肺炎;排除症状性脑转移(神经系统症状不稳定或需要增加皮质醇激素用量)。

分层因素:是否存在脑转移及克唑替尼最佳疗效(CR、PR或未知)。随机分入Brigatinib 90mg或180mg剂量组(起始7天给予90mg)。

结果

1.2014年6月至2015年9月间,纳入18个国家71个中心222例患者,90mg剂量组112例,180mg剂量组110例。脑转移54例(69%),既往接受化疗164 例(74%),克唑替尼最佳疗效为CR/PR144例(65%),亚洲人69例(31%)。中位随访8个月,数据截止至2016年2月。

2.有效性  研究者评价客观有效率(ORR)90mg和180剂量组分别为45%和54%。IRC评价ORR90mg和180mg剂量组分别为48%和53%。

研究者评价中位PFS时间90mg和180mg剂量组分别为9.2个月和12.9个月。

44例患者脑转移可评价,IRC评价90mg和180mg剂量组颅内ORR分别为42%和67%,颅内PFS时间90mg和180mg剂量组分别为15.6个月和12.8个月。

1.安全性 最常见任何级别不良事件:胃肠道毒性(恶心33%/40%,腹泻19%/38%,90mg/ 180mg 剂量组),头痛(28%/27%),咳嗽(18%/34%)。最常见3级以上不良事件:高血压(6%/6%),血肌酸激酶升高(3%/9%),肺炎(3%/5%),脂肪酶增加(4%/3%)。

早期肺毒性:包括呼吸困难、低氧、咳嗽、肺感染、肺炎。中位发生时间2天(1~9天),发生率6%。3级以上7例(3%),均发生在90mg剂量,增量至180mg未再出现。14例发生肺毒性患者,6例暂时中断治疗,1例剂量降低至60mg,7例患者中断治疗。1例因呼吸困难、咳嗽和肺炎7天后死亡,尸检后发现广泛癌性淋巴管病,考虑死于肺癌进展。

90mg和180mg剂量组因不良事件减量发生率分别为7%和20%,剂量中断(≥3天)发生率分别为18%和36%,剂量强度分别为每日90mg和174mg,最常见减量原因为肌酸激酶升高、肺炎、皮疹。

结论

Brigatinib对全身及颅内病灶均持续有效,疗效上180mg优于90mg且安全性可接受。

启示

Brigatinib剂量90mg 和180mg均有效,有效率高持续时间长,起效迅速。180mg剂量组PFS更长,颅内有效率更高,确认ORR54%,颅内有效率64%,中位PFS时间超过1年(研究者评价为12.9个月,IRC评价为15.6个月)。

尽管方法和纳入人群不同,克唑替尼耐药后下一代ALK抑制剂(Brigatinib、色瑞替尼和艾乐替尼)有效率波动在50%~56%之间。临床前数据,Brigatinib较色瑞替尼和艾乐替尼覆盖耐药突变谱更广,对G1202R突变有效,且在本研究得到证实。

安全性数据与既往研究类似,两个剂量组均可接受,3级以上不良事件发生率低。90mg和180mg剂量Brigatinib减量发生率分别为7%和20%,而色瑞替尼为58%,艾乐替尼为23%。

采取90mg使用一周后增量至180mg较起始180mg降低了肺毒性发生率。但Brigatinib使用第一周要密切观察呼吸系统症状,出现后早期停药及干预。

剂量下降可能影响颅内有效性,Ⅱ期ALTA研究证明180mg Brigatinib安全且有效。目前Brigatinib对比克唑替尼一线治疗ALK阳性NSCLC的Ⅲ期ALTA-1L研究正在进行。

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    2017-08-26 lidong40
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    2018-02-14 1219b6c7m57暂无昵称

    对G1202r还是力不从心.3922对付G1202r游刃有余.

    0

  3. 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topicId=null, topicList=[TopicDto(id=3731, encryptionId=f1ed3e3156, topicName=Brigatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e2c339, createdName=by2009, createdTime=Sat Apr 28 16:19:00 CST 2018, time=2018-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1935428, encodeId=138419354289b, content=<a href='/topic/show?id=afcb2324ea' target=_blank style='color:#2F92EE;'>#ALK阳性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2324, encryptionId=afcb2324ea, topicName=ALK阳性NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/4v5DMqK7WnzoBdibNsryQ8OEM5gFSdRH9j3HNCKPfKXlObInweOSHdQPATeTicYp7nvg3bsgicjLgRkdlhrpry21w/132, createdBy=6bf82500013, createdName=ms5822920152752585, createdTime=Sun Apr 15 22:19:00 CST 2018, time=2018-04-15, status=1, ipAttribution=), 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createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Wed May 17 20:38:55 CST 2017, time=2017-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503897, encodeId=7e7a150389e50, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c23f9697922, createdName=yibei, createdTime=Tue May 16 02:19:00 CST 2017, time=2017-05-16, status=1, ipAttribution=)]
  4. 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topicId=null, topicList=[TopicDto(id=3731, encryptionId=f1ed3e3156, topicName=Brigatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e2c339, createdName=by2009, createdTime=Sat Apr 28 16:19:00 CST 2018, time=2018-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1935428, encodeId=138419354289b, content=<a href='/topic/show?id=afcb2324ea' target=_blank style='color:#2F92EE;'>#ALK阳性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2324, encryptionId=afcb2324ea, topicName=ALK阳性NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/4v5DMqK7WnzoBdibNsryQ8OEM5gFSdRH9j3HNCKPfKXlObInweOSHdQPATeTicYp7nvg3bsgicjLgRkdlhrpry21w/132, createdBy=6bf82500013, createdName=ms5822920152752585, createdTime=Sun Apr 15 22:19:00 CST 2018, time=2018-04-15, status=1, ipAttribution=), 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createdTime=Tue May 23 13:11:42 CST 2017, time=2017-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=199819, encodeId=d46a19981956, content=学习并分享!!!:, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Fri May 19 06:28:29 CST 2017, time=2017-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=199314, encodeId=2b151993143f, content=学习了,谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Wed May 17 20:38:55 CST 2017, time=2017-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503897, encodeId=7e7a150389e50, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c23f9697922, createdName=yibei, createdTime=Tue May 16 02:19:00 CST 2017, time=2017-05-16, status=1, ipAttribution=)]
    2018-04-28 by2009
  5. 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  6. 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createdTime=Tue May 23 13:11:42 CST 2017, time=2017-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=199819, encodeId=d46a19981956, content=学习并分享!!!:, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Fri May 19 06:28:29 CST 2017, time=2017-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=199314, encodeId=2b151993143f, content=学习了,谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Wed May 17 20:38:55 CST 2017, time=2017-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503897, encodeId=7e7a150389e50, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c23f9697922, createdName=yibei, createdTime=Tue May 16 02:19:00 CST 2017, time=2017-05-16, status=1, ipAttribution=)]
    2017-09-02 xjy02
  7. 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createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Wed May 17 20:38:55 CST 2017, time=2017-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503897, encodeId=7e7a150389e50, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c23f9697922, createdName=yibei, createdTime=Tue May 16 02:19:00 CST 2017, time=2017-05-16, status=1, ipAttribution=)]
    2017-05-23 卡圣

    学习了,谢谢

    0

  8. 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createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Wed May 17 20:38:55 CST 2017, time=2017-05-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503897, encodeId=7e7a150389e50, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c23f9697922, createdName=yibei, createdTime=Tue May 16 02:19:00 CST 2017, time=2017-05-16, status=1, ipAttribution=)]
    2017-05-19 大爰

    学习并分享!!!:

    0

  9. 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    2017-05-17 卡圣

    学习了,谢谢

    0

  10. 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    2017-05-16 yibei