ASCO GU 2021:固定剂量的Durvalumab单药治疗尿道肿瘤具有良好的安全性(STRONG研究)

2021-02-16 MedSci原创 MedSci原创

对于泌尿生殖系统肿瘤学家治疗的肿瘤,晚期尿路上皮癌的预后最差,标准治疗为接受铂类诱导化疗。但是,即使采用这种疗法,由于化疗耐药性的发展,其复发率和疾病进展仍然很高,并且总生存期仍然很短。

对于泌尿生殖系统肿瘤学家治疗的肿瘤,晚期尿路上皮癌的预后最差,标准治疗为接受铂类诱导化疗。但是,即使采用这种疗法,由于化疗耐药性的发展,其复发率和疾病进展仍然很高,并且总生存期仍然很短。

2018年,美国食品药物监督管理局(FDA)批准对durvalumab进行加速审批,用于治疗在含铂化疗期间或之后出现疾病进展,或在用含铂化疗的新辅助或辅助方法进行治疗的12个月之内出现了疾病进展的局部晚期或转移性尿路上皮癌患者。

ASCO 2020年年会上报道的JAVELIN Bladder 100研究中,作为最佳支持治疗的一线维持治疗,增加了PD-L1靶向治疗药物avelumab的使用,证明了在此期间没有疾病进展的患者的总生存期得到了改善。在铂类化疗(CT)进展后,durvalumab(anti-PD-L1)已被批准用于治疗转移性尿路上皮癌(mUC)(见:NEJM:avelumab用于晚期尿路上皮癌患者化疗后的维持治疗)(ASCO 2020丨晚期尿路上皮癌又有新进展,Avelumab维持治疗联合BSC可使总生存期延长7.1个月!)。

在2021年ASCO泌尿生殖系统癌症研讨会(ASCO GU)上的海报展示中,Sonpavde博士及其同事介绍了STRONG研究(NCT03084471)的数据,旨在了解durvalumab在铂和非铂预处理后的长期安全性和有效性。本研究旨在观察在铂/非铂类药物或非铂类药物治疗后进展的尿路上皮和非尿路上皮尿道癌患者中固定剂量的durvalumab(1500 mg,Q4W)的安全性。

AK_3rd_Picture1.png

作者评估了所谓特殊关注的不良事件(AESI)的主要终点,这些不良事件与可能需要干预的炎性或免疫介导机制(例如,类固醇/免疫抑制剂)有关,包括免疫介导的不良事件(imAE) 。

作者包括发病日期在首次给药日期或之后以及终止研究后长达90天的AE病人。其次,作者检查了严重的不良事件和总生存(OS),并进一步探索了终点,包括客观反应率(ORR)和疾病控制率(DCR;研究人员根据RECIST 1.1进行了评估)。

研究纳入867名接受durvalumab单药治疗的患者。与该患者人群保持一致,中位年龄为68.1岁,男性为80.0%。 ECOG PS 0-1为87.1%,ECOG PS 2为12.7%。 包括患者在内的绝大多数患者(96.3%)具有尿路上皮组织学,包括尿道上皮变体,在有可用数据的患者中,有41.4%的患者PD-L1肿瘤表达高(定义为≥25%)(239/577)。

中位治疗和随访时间分别为12.1周(范围1-128)和13.8个月(范围0.0-28.8)中,在AESI等级为3级或更高的队列中,占50.5%的患者占8%。与治疗有关的死亡发生在9例患者中。

AK_3rd_Picture2.png

截至2020年3月31日,有30.8%的患者接受了生存期随访,中位总体生存期为7.0个月(95%CI:6.4-8.2)。 1年和2年生存率分别为35.8%(95%CI:32.5-39.2)和20.2%(95%CI:16.5-24.1)。 PD-L1高表达患者的中位总生存期较高[9.3 mo(95%CI:6.7-12.7)vs 6.5 mo(95%CI:5.8-8.1)。有趣的是,无论是尿路上皮和非尿路上皮患者,中位总生存期均为7.0个

AK_3rd_Picture3.png

因此,每4周进行一次固定剂量的durvalumab单药治疗在该患者群体中具有可接受的安全性,很方便。

原始出处:

ASCO GU 2021: An Open-Label, Multicenter, Phase IIIb Study of Patients With Urinary Tract Carcinoma (STRONG): Final Analysis for Fixed-Dose Durvalumab Monotherapy (Module A)

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    2022-01-29 snf701207
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    2021-06-06 lifestar
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    2021-06-10 quxin068
  5. [GetPortalCommentsPageByObjectIdResponse(id=1912543, encodeId=6b51191254327, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat Jan 29 02:59:18 CST 2022, time=2022-01-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1687749, encodeId=cb15168e749f0, content=<a href='/topic/show?id=be223633375' target=_blank style='color:#2F92EE;'>#单药治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36333, encryptionId=be223633375, topicName=单药治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2bef28414326, createdName=12498717m75(暂无昵称), createdTime=Sat Apr 24 19:59:18 CST 2021, time=2021-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1769175, encodeId=c9301e691753f, content=<a href='/topic/show?id=ebef4e52844' target=_blank style='color:#2F92EE;'>#尿道#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47528, encryptionId=ebef4e52844, topicName=尿道)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b63c37986505, createdName=lifestar, createdTime=Sun Jun 06 02:59:18 CST 2021, time=2021-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939137, encodeId=d631193913e99, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, 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=Thu Jun 10 06:59:18 CST 2021, time=2021-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924862, encodeId=5c4492486233, content=好,优秀的work, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEIF7OaP2iaaUz8P5M1thS6iaXU2pK86Ria5cPH2ZlX5dficZsehWgia5djJOQJ6RAARfGMvhh4m0RSpDPA/132, createdBy=08931946567, createdName=周哲, createdTime=Tue Feb 16 10:44:30 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924857, encodeId=01fc92485e26, content=尿道肿瘤太少见了, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Tue Feb 16 10:15:36 CST 2021, time=2021-02-16, status=1, ipAttribution=)]
    2021-02-16 周哲

    好,优秀的work

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1912543, encodeId=6b51191254327, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat Jan 29 02:59:18 CST 2022, time=2022-01-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1687749, encodeId=cb15168e749f0, content=<a href='/topic/show?id=be223633375' target=_blank style='color:#2F92EE;'>#单药治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36333, encryptionId=be223633375, topicName=单药治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2bef28414326, createdName=12498717m75(暂无昵称), createdTime=Sat Apr 24 19:59:18 CST 2021, time=2021-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1769175, encodeId=c9301e691753f, content=<a href='/topic/show?id=ebef4e52844' target=_blank style='color:#2F92EE;'>#尿道#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47528, encryptionId=ebef4e52844, topicName=尿道)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b63c37986505, createdName=lifestar, createdTime=Sun Jun 06 02:59:18 CST 2021, time=2021-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1939137, encodeId=d631193913e99, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, 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=Thu Jun 10 06:59:18 CST 2021, time=2021-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924862, encodeId=5c4492486233, content=好,优秀的work, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEIF7OaP2iaaUz8P5M1thS6iaXU2pK86Ria5cPH2ZlX5dficZsehWgia5djJOQJ6RAARfGMvhh4m0RSpDPA/132, createdBy=08931946567, createdName=周哲, createdTime=Tue Feb 16 10:44:30 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=924857, encodeId=01fc92485e26, content=尿道肿瘤太少见了, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200914/f1df8506d5cb4909bac2efc340b6c1fe/dcc6dd2dbec44613838b555fbe723804.jpg, createdBy=686b1371609, createdName=liyu7822, createdTime=Tue Feb 16 10:15:36 CST 2021, time=2021-02-16, status=1, ipAttribution=)]
    2021-02-16 liyu7822

    尿道肿瘤太少见了

    0

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