Lancet Oncol：伊布替尼联合BR与BR对比治疗rrCLL/SLL患者：随机对照双盲Ⅲ期研究

2017-10-17 梅斯医学梅斯医学

研究背景与目的•CLL/SLL目前仍然难以治愈，多数患者在初始治疗后均会复发•苯达莫司汀联合利妥昔单抗(BR)常用于复发/难治患者的治疗•伊布替尼是首个每日一次口服BTK抑制剂，被NCCN指南优先推荐用于复发患者的治疗(1类推荐)•在一项1b期研究中，伊布替尼联合BR治疗CLL总缓解率达93%，36个月时PFS 70%•Ⅲ期研究HELIOS旨在评估伊布替尼联合BR与安慰剂联合BR对比治疗rrCLL

研究背景与目的

•CLL/SLL目前仍然难以治愈，多数患者在初始治疗后均会复发

•苯达莫司汀联合利妥昔单抗(BR)常用于复发/难治患者的治疗

•伊布替尼是首个每日一次口服BTK抑制剂，被NCCN指南优先推荐用于复发患者的治疗(1类推荐)

•在一项1b期研究中，伊布替尼联合BR治疗CLL总缓解率达93%，36个月时PFS 70%

•Ⅲ期研究HELIOS旨在评估伊布替尼联合BR与安慰剂联合BR对比治疗rrCLL/SLL患者的疗效及安全性

研究方法与入组人群

•国际多中心、随机、双盲、安慰剂对照Ⅲ期研究，入组时间：2012年9月-2014年1月，平均随访17个月

研究结果——PFS及OS

•伊布替尼+BR显著改善IRC评估的PFS(NR vs. 13.3m)，随访18个月时PFS分别为79%和24%(P＜0.0001)

•两组中位OS均未达到，但安慰剂组90例(31%) 患者交叉进入伊布替尼组治疗

•在所有亚组中，伊布替尼治疗的PFS均显著改善

研究结果——ORR

•伊布替尼+BR组IRC评估的ORR显著更高(83% vs. 68%,P＜0.0001)

•伊布替尼+BR组完全缓解率(CR/CRi)显著高于安慰剂+BR组(10% vs. 3%)

研究结果——MRD评估

•伊布替尼+BR组MRD阴性缓解率显著高于安慰剂+BR组(12.8% vs. 4.8%, P=0.0011)

•在CR/Cri患者中伊布替尼+BR组MRD阴性缓解率显著高于安慰剂+BR组(4.2% vs. 1.4%)

研究结果——安全性

•最常见的所有等级不良反应为中性粒细胞减少及恶心

•伊布替尼组77%(227/287) 患者及安慰剂组74%(212/287)患者报告了3-4级不良反应

•最常见的3-4级不良反应为中性粒细胞减少(伊布替尼组54% vs. 安慰剂组51%)和血小板减少 (两组均15%)

研究意义

•第一个评估伊布替尼联合苯达莫司汀和利妥昔单抗(BR)治疗rrCLL/SLL的Ⅲ期试验

•伊布替尼+BR与安慰剂+BR相比：

– 显著降低疾病进展或死亡风险80%

– 显著改善ORR

•伊布替尼+BR的安全性与单药的安全性一致

•结果证实伊布替尼联合BR治疗rrCLL/SLL优于目前的标准疗法

•HELIOS是第二个证实伊布替尼在rrCLL/SLL患者中可显著延缓复发的随机Ⅲ期研究

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2018-02-04 amyloid

#对照#

40 0
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2017-12-22 minlingfeng

#Oncol#

39 0
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2018-09-17 howi

#Lancet#

34 0
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2017-10-19 hongbochen

#伊布替尼#

41 0
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2017-10-19 xlxchina

#双盲#

28 0
[GetPortalCommentsPageByObjectIdResponse(id=1775354, encodeId=0be11e7535448, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Sun Feb 04 13:41:00 CST 2018, time=2018-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865150, encodeId=f8fa18651506b, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Fri Dec 22 15:41:00 CST 2017, time=2017-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1829255, encodeId=e52e1829255f8, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Mon Sep 17 02:41:00 CST 2018, time=2018-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1288718, encodeId=865f1288e1805, content=<a href='/topic/show?id=11fd2565952' target=_blank style='color:#2F92EE;'>#伊布替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25659, encryptionId=11fd2565952, topicName=伊布替尼)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0a8e213, createdName=hongbochen, createdTime=Thu Oct 19 08:41:00 CST 2017, time=2017-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573051, encodeId=b96015e3051eb, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=db3115807173, createdName=xlxchina, createdTime=Thu Oct 19 08:41:00 CST 2017, time=2017-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631086, encodeId=3a0316310864c, content=<a href='/topic/show?id=50e0485323' target=_blank style='color:#2F92EE;'>#CLL/SLL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4853, encryptionId=50e0485323, topicName=CLL/SLL)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=32d321676246, createdName=mnda, createdTime=Thu Oct 19 08:41:00 CST 2017, time=2017-10-19, status=1, ipAttribution=)]
2017-10-19 mnda

#CLL/SLL#

39 0

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Lancet Oncol：伊布替尼联合BR与BR对比治疗rrCLL/SLL患者：随机对照双盲Ⅲ期研究

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