SABCS 2014:Pembrolizumab使部分三阴性乳腺癌患者产生持续应答

2014-12-14 MedSci MedSci原创

第37届圣安东尼奥乳腺癌研讨会上的一项1期研究( 摘要号#S1-09.)结果显示,对于具有PD-L1肿瘤的经化疗的转移性,三阴性乳腺癌患者,人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答。“目前没有获准的用于转移性三阴性乳腺癌的靶向治疗,该病患者的中位生存期大约为1年,”芝加哥大学医学助理教授和乳腺肿瘤医学项目的副主任 Rita Nanda博士说。 “

第37届圣安东尼奥乳腺癌研讨会上的一项1期研究( 摘要号#S1-09.)结果显示,对于具有PD-L1肿瘤的经化疗的转移性,三阴性乳腺癌患者,人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答。

“目前没有获准的用于转移性三阴性乳腺癌的靶向治疗,该病患者的中位生存期大约为1年,”芝加哥大学医学助理教授和乳腺肿瘤医学项目的副主任 Rita Nanda博士说。 “pembrolizumab在PD-L1表达的三阴性乳腺癌患者中表现出了有潜力的活性,非常令人振奋,当然值得进一步研究。”Pembrolizumab已经证明在多种肿瘤类型表现出临床活性。今年早些时候,美国FDA批准该药用于治疗晚期转移性黑色素瘤。

该研究纳入了32名具有PD-L1阳性肿瘤的转移性三阴性乳腺癌患者。所有患者早期疾病经治疗后均复发或进展为晚期疾病。 关键的排除标准包括全身激素治疗,自身免疫性疾病史及存在未经处理的活跃脑转移。

队列的平均年龄为51.9岁(范围为,29-72)。大多数队列是白种人(78.1%),并具有0或1(96.9%)的ECOG评分。四名女性(12.5%)曾接受过脑转移治疗。15例(42.8%)患者接受过至少三个疗法治疗转移性疾病,7名患者(21.9%)接受过至少五个疗法治疗晚期癌症。大多数患者接受过紫杉烷类,蒽环霉素和以卡培他滨及铂类为基础的治疗。

所有的患者每2周通过静脉滴注接受10mg/kg 的pembrolizumab。每8周进行缓解评估。患者有资格继续留在研究中,只要他们还能获益并没有经历不可接受的毒性。研究将安全性,耐受性和抗肿瘤活性作为首要终点。中位随访时间为9.9个月(范围,0.4-15.1)。27例患者有可以评估的缓解情况,其中90%曾经历了新辅助或辅助化疗。

结果发现,1例完全缓解(3.7%)和4例部分缓解(14.8%),相当于18.5%的总缓解率。4或5例有缓解的患者接受过至少三线化疗来治疗晚期疾病。所有5位患者均经历了紫杉烷和卡培他滨为基础的治疗,4位接受了蒽环类和3位经历了铂为基础的治疗。另7位患者(25.9%)达到病情稳定,12例患者(44.4%)治疗期间发生疾病进展。3例患者(11.1%)由于首次基线后扫描发现疾病进展或治疗相关的不良事件而中断治疗,因此,没有经过评估。

在分析时,5位有缓解的患者中有3位仍然在治疗,这些患者已治疗了≥48周。分析时中止治疗的患者已经接受了40周的治疗。

Nanda表示“这反应了治疗产生应答的持久性”。中位缓解时间尚未达到(范围 15至>40周)。中位PFS为1.9个月(95%CI,1.7-5.4),6个月时的PFS为23.3%。

在不良反应方面,表出也比较良好。只有18名患者(56.3%)发生了治疗相关的不良事件。最常见的是关节痛(18.8%),乏力(18.8%),肌痛(15.6%)和恶心(15.6%)。这些毒性的绝大多数易于管理,并不需要中断治疗。四名患者(12.5%)经历了3级事件,1位患者(3.1%)经历了4级事件,3例(9.4%)出现了严重的不良反应事件。一名患者因弥漫性血管内凝血死亡。

“可接受的安全性和耐受性,再加上有前途的抗肿瘤活性,支持了pembrolizumab用于晚期三阴性乳腺癌的进一步发展,”Nanda表示,三阴性乳腺癌患者的2期研究计划在2015年上半年开始报名。

评论1:HemOnc Today 编委成员 Edith A. Perez, MD


通常并没有认为乳腺癌是一种需要进行免疫调节治疗的疾病。这就是首先其他类型肿瘤中开始免疫治疗的原因之一。不过,我很高兴能够看到对于一组顽固性、晚期转移性乳腺癌患者开展这样的循证学研究,这意味着免疫调节治疗对于该疾病有活性。扩大这一研究,以确定该药单独治疗的真实活性将会很棒。并且-重要的是-探索该药如何结合其他治疗策略应用于三阴性乳腺癌患者。这类患者的选择很有限,这一研究为我们带来了希望。

评论2:德克萨斯大学医学部安德森癌症中心的Jennifer K. Litton博士

大家都继续看好乳腺癌的免疫治疗。这项研究表明 - 正如我们所看到在其他类型肿瘤的一些研究 - 患者只有一小部分可能会有应答,但对于那些有应答的患者,这种应答往往是长期的、持续的,这是其他疗法所不常见的。我认为我们不应该评判该研究是一个阳性的还是阴性的。这是1期研究。这不是一项能够告诉我们,'是否应该把这项治疗作为标准治疗?"的研究,这是一个让我们思考:“我们是否应该进行下一步2期的研究?”的研究。该研究的数据显示,曾接受过很多治疗的三阴性乳腺癌患者有持续的应答,我认为这真的值得进一步评估。本质上,乳腺癌不像黑色素瘤和其他一些具有较高的免疫浸润的肿瘤。但是,就利用免疫系统的而言,目前我们还只停留在表面。

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    2015-07-20 feather89
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encryptionId=45ae1e1830, topicName=ABC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a54039078223, createdName=cmj21wellington, createdTime=Wed Jun 24 00:29:00 CST 2015, time=2015-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2047924, encodeId=237b204e92424, content=<a href='/topic/show?id=12e49e53102' target=_blank style='color:#2F92EE;'>#阴性乳腺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97531, encryptionId=12e49e53102, topicName=阴性乳腺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f65b226, createdName=circumcision, createdTime=Thu Jan 15 19:29:00 CST 2015, time=2015-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272491, encodeId=861c12e24917d, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, 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encodeId=24c015e09386e, content=<a href='/topic/show?id=f42823e48d7' target=_blank style='color:#2F92EE;'>#乳腺癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23748, encryptionId=f42823e48d7, topicName=乳腺癌患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Tue Dec 16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587482, encodeId=c776158e482cf, content=<a href='/topic/show?id=e03515826f8' target=_blank style='color:#2F92EE;'>#SABCS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15826, encryptionId=e03515826f8, topicName=SABCS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=826117479684, createdName=guguangxiang, createdTime=Tue Dec 16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=13093, encodeId=406b130931a, content=三阴性乳腺癌患者人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答,研究结果令人鼓舞, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=809381710, createdName=cbp, createdTime=Sun Dec 14 15:42:00 CST 2014, time=2014-12-14, status=1, ipAttribution=)]
    2015-02-14 chendoc242
  4. 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16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=13093, encodeId=406b130931a, content=三阴性乳腺癌患者人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答,研究结果令人鼓舞, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=809381710, createdName=cbp, createdTime=Sun Dec 14 15:42:00 CST 2014, time=2014-12-14, status=1, ipAttribution=)]
  5. 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16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=13093, encodeId=406b130931a, content=三阴性乳腺癌患者人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答,研究结果令人鼓舞, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=809381710, createdName=cbp, createdTime=Sun Dec 14 15:42:00 CST 2014, time=2014-12-14, status=1, ipAttribution=)]
  6. 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16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=13093, encodeId=406b130931a, content=三阴性乳腺癌患者人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答,研究结果令人鼓舞, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=809381710, createdName=cbp, createdTime=Sun Dec 14 15:42:00 CST 2014, time=2014-12-14, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1725699, encodeId=f77b1e2569981, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Mon Jul 20 14:29:00 CST 2015, time=2015-07-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911672, encodeId=abc819116e26d, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, 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objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Tue Dec 16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1458651, encodeId=e54b1458651e3, content=<a href='/topic/show?id=3ef91982030' target=_blank style='color:#2F92EE;'>#三阴性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19820, encryptionId=3ef91982030, topicName=三阴性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a5666112721, createdName=xlysu, createdTime=Tue Dec 16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1570938, encodeId=24c015e09386e, content=<a href='/topic/show?id=f42823e48d7' target=_blank style='color:#2F92EE;'>#乳腺癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23748, encryptionId=f42823e48d7, topicName=乳腺癌患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Tue Dec 16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587482, encodeId=c776158e482cf, content=<a href='/topic/show?id=e03515826f8' target=_blank style='color:#2F92EE;'>#SABCS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15826, encryptionId=e03515826f8, topicName=SABCS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=826117479684, createdName=guguangxiang, createdTime=Tue Dec 16 02:29:00 CST 2014, time=2014-12-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=13093, encodeId=406b130931a, content=三阴性乳腺癌患者人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答,研究结果令人鼓舞, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=809381710, createdName=cbp, createdTime=Sun Dec 14 15:42:00 CST 2014, time=2014-12-14, status=1, ipAttribution=)]
    2014-12-16 xlysu
  8. 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  9. 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  10. 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    2014-12-14 cbp

    三阴性乳腺癌患者人源化抗PD-1抗体pembrolizumab可以使其中近20%的患者产生持久应答,研究结果令人鼓舞

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