ASCO肝细胞癌(HCC)相关口头报告速览

2020-05-21 任冉 健康界

本文主要涉及多纳非尼与索拉非尼在临床上的效果对比以及阿帕替尼能否作为晚期肝癌患者的二线用药。

受COVID-19疫情影响,2020年美国临床肿瘤学会年会(ASCO2020)将于美国东部时间2020年5月29~31日以线上会议的形式举行。会议将基于24种疾病和专业进行250多个口头摘要演示和2500个海报演示。

近日,ASCO年会已经在线上公布了大部分研究的摘要( 除LBA外)。跟随小编的步伐,开启“云年会”模式,抢先浏览今年ASCO年会入选的部分国内口头报告。上次分享了乳腺癌相关的内容,这次我们关注一下肝癌的相关内容。

Donafenib与sorafenib作为晚期肝细胞癌的一线治疗:一项开放标签,随机,多中心II / III期试验。

四川大学华西医院毕锋教授等

背景:

索拉非尼目前仍然是晚期肝细胞癌(HCC)的标准一线治疗方法。多纳非尼是一种新型的多激酶抑制剂,在先前的HCC Ib期研究中显示出潜在的益处。

方法:

在这项开放标签的随机II / III期临床试验(ZGDH3)中,来自中国37个地区的患有不可切除或转移性HCC,Child-Pugh肝功能评分≤7且既往没有全身性治疗的患者入选,随机分配(1: 1)每天两次口服多纳非尼(0.2 g)或索拉非尼(0.4 g),直至无法忍受的毒性或疾病进展。主要终点是总生存期(OS)。功效分析主要基于全分析集(FAS)。

结果:

在2016年3月至2018年4月期间间,对668例患者进行了随机分组(多纳非尼(334);索拉非尼(334)),并纳入意向性治疗(ITT)组,其中FAS分析了659例患者(328 vs 331)。多纳非尼与索拉非尼相比,在FAS(12.1个月对10.3个月,危险比0.831,95%可信区间0.699-0.988,p=0.0363)和ITT(12.0个月对10.1个月,0.839,0.706-0.996,p=0.0446)中OS显著延长。中位无进展生存期(3.7个月对3.6个月,p=0.2824)、客观缓解率(4.6%对2.7%,p=0.2448)和疾病控制率(30.8%对28.7%,p=0.5532)无显著差异。分别有191名(57.4%)和224名(67.5%)患者发生3级或更严重的不良事件(AE)(p = 0.0082),并且特别关注的AE和导致治疗中断的AE发生于287(86.2%)vs 309(93.1%,p = 0.0049)和101(30.3%)对 141(42.5%,p = 0.0013)。数量较少的接受多纳非尼治疗的患者报告了严重的不良事件(55 [16.5%] 比 67 [20.2%],p= 0.2307)。多纳非尼的常见不良事件包括手足皮肤反应(50.5%),天冬氨酸转氨酶增加(40.5%),血胆红素升高(39.0%),血小板计数减少(37.8%)和腹泻(36.6%)。

结论:

与索拉非尼相比,多纳非尼显着改善OS,并具有良好的安全性和耐受性。多纳非尼有望成为治疗晚期HCC的优质一线药物。

阿帕替尼作为中国晚期肝细胞癌的二线治疗:一项随机,安慰剂对照,双盲,III期研究

四川大学华西医院李秋教授等

背景:

中国患者占全球肝细胞癌(HCC)病例的50%以上,并且在病因,生物学行为,治疗策略和预后方面具有特殊特征。这项研究的目的是评估在预处理过的晚期HCC患者中,靶向血管内皮生长因子受体2的抑制剂apatinib的疗效和安全性。

方法:

在这项在中国31个地区进行的随机、安慰剂对照、双盲、Ⅲ期临床试验中,入选接受了至少一种系统疗法(包括索拉非尼和奥沙利铂为主的化疗,这是中国另一种一线疗法)且Child-Pugh分级为A或B≤7分的的HCC患者被纳入研究。将患者随机分配(2:1),每天口服一次750 mg阿帕替尼或安慰剂,在28天的治疗周期中按ECOG表现状态(0或1),既往索拉非尼治疗(是或否),肝外扩散和/或大血管浸润(是或否)进行分层。主要终点是总体生存期(OS)。

结果:

2014年4月1日至2017年5月03期间,将393名患者随机分组并接受至少一剂研究治疗药物(阿帕替尼组261人,安慰剂组132人)。阿帕替尼的中位OS明显长于安慰剂(8.7个月[95%CI 7.5-9.8] vs 6.8个月[95%CI 5.7-9.1];危险比0.785 [95%CI 0.617-0.998]; p = 0.0476 )。与安慰剂组相比,阿帕替尼组患者的中位无进展生存期(PFS)也延长(4.5个月[95%CI 3.9-4.7] vs1.9个月[95%CI 1.9-2.0];危险比0.471 [95%CI 0.369-0.601];p˂0.0001)。阿帕替尼的客观缓解率为10.7%(95%CI 7.2-15.1),而安慰剂为1.5%(95%CI 0.2-5.4)。据报告,与治疗相关的不良事件(TRAE)在阿帕替尼组中为250(97.3%)例,在安慰剂组中为92(70.8%)例。3级和4级的最常见3至4级治疗相关不良事件(TRAEs)是高血压(阿帕替尼组71 [27.6%] PTS VS,手足综合征(46 [17.9%],安慰剂组3 [2.3%] PTS)VS 0),血小板计数下降(34[13.2%]vs 1[0.8%]),中性粒细胞计数下降(27[10.5%]vs0)。24例(9.3%)服用阿帕蒂尼的患者和13例(10.0%)服用安慰剂的患者因不良事件死亡,研究者均未发现与治疗相关。

结论:

在中国晚期肝癌患者中,阿帕替尼能显著延长OS和PFS,且耐受性好,安全性好。

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1863499, encodeId=329618634995f, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Fri Sep 25 08:35:14 CST 2020, time=2020-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939055, encodeId=e3641939055b7, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sat Oct 24 09:35:14 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1978985, encodeId=3c0619e8985e9, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sat Mar 27 05:35:14 CST 2021, time=2021-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259518, encodeId=293912595183d, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Sat May 23 02:35:14 CST 2020, time=2020-05-23, status=1, ipAttribution=)]
    2020-09-25 xjy02
  2. [GetPortalCommentsPageByObjectIdResponse(id=1863499, encodeId=329618634995f, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Fri Sep 25 08:35:14 CST 2020, time=2020-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939055, encodeId=e3641939055b7, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sat Oct 24 09:35:14 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1978985, encodeId=3c0619e8985e9, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sat Mar 27 05:35:14 CST 2021, time=2021-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259518, encodeId=293912595183d, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Sat May 23 02:35:14 CST 2020, time=2020-05-23, status=1, ipAttribution=)]
    2020-10-24 quxin068
  3. [GetPortalCommentsPageByObjectIdResponse(id=1863499, encodeId=329618634995f, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Fri Sep 25 08:35:14 CST 2020, time=2020-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939055, encodeId=e3641939055b7, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sat Oct 24 09:35:14 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1978985, encodeId=3c0619e8985e9, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sat Mar 27 05:35:14 CST 2021, time=2021-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259518, encodeId=293912595183d, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Sat May 23 02:35:14 CST 2020, time=2020-05-23, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1863499, encodeId=329618634995f, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Fri Sep 25 08:35:14 CST 2020, time=2020-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939055, encodeId=e3641939055b7, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sat Oct 24 09:35:14 CST 2020, time=2020-10-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1978985, encodeId=3c0619e8985e9, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Sat Mar 27 05:35:14 CST 2021, time=2021-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1259518, encodeId=293912595183d, content=<a href='/topic/show?id=2200854517' target=_blank style='color:#2F92EE;'>#HCC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8545, encryptionId=2200854517, topicName=HCC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8e4c53, createdName=jiyangfei, createdTime=Sat May 23 02:35:14 CST 2020, time=2020-05-23, status=1, ipAttribution=)]
    2020-05-23 jiyangfei