Lancet Oncol:达雷妥尤单抗维持治疗可显著降低多发性骨髓瘤患者的疾病进展及死亡风险

2021-09-16 Nebula MedSci原创

达雷妥尤单抗维持治疗长达两年可显著降低多发性骨髓瘤患者的疾病进展及死亡风险

CASSIOPEIA 研究第 1 部分的结果显示,可进行自体干细胞移植(ASCT)的新确诊的多发性骨髓瘤患者,采用达雷妥尤单抗、硼替佐米、沙利度胺和地塞米松(D-VTd)方案作为诱导和巩固治疗方案时的缓解深度和无进展生存期均显著优于硼替佐米、沙利度胺和地塞米松(VTd)方案。在CASSIOPEIA 研究的第 2 部分,研究人员对比了达雷妥尤单抗维持 vs 仅观察对患者预后的影响。

CASSIOPEIA 研究是一项在欧洲 111 处开展的包含两部分的开放标签、随机的 3 期试验,招募了 18-65 岁的新确诊的ECOG表现状态 0-2 分的多发性骨髓瘤患者。在第 1 部分,患者被随机(1:1)分成两组,接受 D-VTd 或 VTd 方案诱导和巩固治疗。获得部分缓解或更好缓解的患者被随机(1:1)成两组,接受达雷妥尤单抗(16 mg/kg,静滴,1次/8周)或仅随访观察,直到满两年。第 2 部分的主要终点是从第 2 次随机分组起的无进展生存期。

达雷妥尤单抗维持组和观察组的无进展生存率

2016年5月30日至2018年6月18日,共有 886 位患者(D-VTd组 543 位中有 458 位,VTd 组 542 位中有 428 位)被随机分至达雷妥尤单抗维持组(n=442)或观察组(n=444)。从第 2 次随机分组后,中位随访了 35.4 个月(范围 30.2-39.9 个月),达雷妥尤单抗组的中位无进展生存期未达到(95% CI 不可评估[NE]-NE),而观察组的是 46.7 个月(40.0-NE;风险比 0.53, 95% CI 0.42-0.68, p<0.0001)。对无进展生存结果的预设分析显示,维持治疗与诱导和巩固治疗之间存在显著的相互作用(p<0.0001)。

不良事件发生情况

最常见的 3-4 级不良事件是淋巴细胞减少(达雷妥尤单抗组 vs 观察组:4% vs 2%)、高血压(3% vs 2%)和白细胞减少(2% vs 2%)。达雷妥尤单抗组和观察组分别有 100 位(23%)和84 位(19%)患者发生了严重不良事件。达雷妥尤单抗组发生了两例不良事件导致的死亡(一例感染性休克和一例自然杀伤细胞淋巴母细胞淋巴瘤),均与治疗相关。

总而言之,达雷妥尤单抗维持治疗长达两年相比只是随访观察可显著降低多发性骨髓瘤患者的疾病进展及死亡风险

原始出处:

Philippe Moreau, et al. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. The Lancet Oncology. September 13, 2021. https://doi.org/10.1016/S1470-2045(21)00428-9

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    2022-04-28 howi
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    2022-05-23 jml2009
  5. [GetPortalCommentsPageByObjectIdResponse(id=1907772, encodeId=ea7e190e772c8, content=<a href='/topic/show?id=fdcee0731d2' target=_blank style='color:#2F92EE;'>#疾病进展#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70731, encryptionId=fdcee0731d2, topicName=疾病进展)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5662228, createdName=mjldent, createdTime=Sun Aug 14 16:36:52 CST 2022, time=2022-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866223, encodeId=75481866223bd, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Tue Nov 16 15:36:52 CST 2021, time=2021-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831303, encodeId=a38c1831303d4, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Apr 28 16:36:52 CST 2022, time=2022-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890296, encodeId=13d018902965d, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Mon May 23 10:36:52 CST 2022, time=2022-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256128, encodeId=1bdb125612843, content=<a href='/topic/show?id=587f6339050' target=_blank style='color:#2F92EE;'>#死亡风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63390, encryptionId=587f6339050, topicName=死亡风险)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sat Sep 18 07:36:52 CST 2021, time=2021-09-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1052145, encodeId=9ba310521458c, content=<a href='/topic/show?id=5655104409bd' target=_blank style='color:#2F92EE;'>#达雷妥单抗#</a>维持治疗长达两年相比只是随访观察可显著降低<a href='/topic/show?id=dd85431162e' target=_blank style='color:#2F92EE;'>#多发性骨髓瘤#</a>患者的疾病进展及死亡风险。, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104409, encryptionId=5655104409bd, topicName=达雷妥单抗), TopicDto(id=43116, encryptionId=dd85431162e, topicName=多发性骨髓瘤)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Thu Sep 16 23:34:54 CST 2021, time=2021-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1052650, encodeId=ffb51052650a1, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Sep 16 19:36:52 CST 2021, time=2021-09-16, status=1, ipAttribution=)]
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    2021-09-16 病毒猎手

    #达雷妥单抗#维持治疗长达两年相比只是随访观察可显著降低#多发性骨髓瘤#患者的疾病进展及死亡风险。

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1907772, encodeId=ea7e190e772c8, content=<a href='/topic/show?id=fdcee0731d2' target=_blank style='color:#2F92EE;'>#疾病进展#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70731, encryptionId=fdcee0731d2, topicName=疾病进展)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5662228, createdName=mjldent, createdTime=Sun Aug 14 16:36:52 CST 2022, time=2022-08-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866223, encodeId=75481866223bd, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Tue Nov 16 15:36:52 CST 2021, time=2021-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831303, encodeId=a38c1831303d4, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Apr 28 16:36:52 CST 2022, time=2022-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890296, encodeId=13d018902965d, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Mon May 23 10:36:52 CST 2022, time=2022-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256128, encodeId=1bdb125612843, content=<a href='/topic/show?id=587f6339050' target=_blank style='color:#2F92EE;'>#死亡风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63390, encryptionId=587f6339050, topicName=死亡风险)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sat Sep 18 07:36:52 CST 2021, time=2021-09-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1052145, encodeId=9ba310521458c, content=<a href='/topic/show?id=5655104409bd' target=_blank style='color:#2F92EE;'>#达雷妥单抗#</a>维持治疗长达两年相比只是随访观察可显著降低<a href='/topic/show?id=dd85431162e' target=_blank style='color:#2F92EE;'>#多发性骨髓瘤#</a>患者的疾病进展及死亡风险。, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104409, encryptionId=5655104409bd, topicName=达雷妥单抗), TopicDto(id=43116, encryptionId=dd85431162e, topicName=多发性骨髓瘤)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211210/ede9c51184aa4f54ae6c1164cfb8eeac/967dbf3eff2943c7bf3ccfec3a776ab0.JPG, createdBy=a33789389, createdName=病毒猎手, createdTime=Thu Sep 16 23:34:54 CST 2021, time=2021-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1052650, encodeId=ffb51052650a1, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Sep 16 19:36:52 CST 2021, time=2021-09-16, status=1, ipAttribution=)]
    2021-09-16 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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