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Lancet oncol:ARIEL3试验:Rucaparib维持治疗铂敏感性复发性卵巢癌超过2年后的探索性分析

2020-06-09 QQY MedSci原创

在ARIEL3试验(评估PARP抑制剂rucaparib用于复发性卵巢癌)中,rucaparib维持治疗可较安慰剂显著提高患者的无进展存活期。现Ledermann等人将预先确定的、研究者评估的、探索性

在ARIEL3试验(评估PARP抑制剂rucaparib用于复发性卵巢癌)中,rucaparib维持治疗可较安慰剂显著提高患者的无进展存活期。现Ledermann等人将预先确定的、研究者评估的、探索性进展后终点和更新的安全性数据于近日发表在《The Lancet Oncology》上。

ARIEL3试验是一项正在进行的(招募已完成)、随机化的安慰剂为对照的3期试验,招募了年满18岁的铂敏感的高级别浆液性或子宫内膜样卵巢、原发性腹膜或输卵管癌患者,要求ECOG表现状态0或1分,既往至少接受过两次以铂类为基础的化疗,并经最后一次铂类化疗后有所缓解。受试者被按2:1随机分至口服rucaparib(600 mg,2/日)或安慰剂,28天一疗程。研究者评估的无进展存活期(主要结点)已报道。现对无化疗间隔(CFI)、第一次后续治疗开始时间(TFST)、后续治疗后疾病进展或死亡时间(PFS2)、第二次后续治疗开始时间(TSST)和更新的安全性进行分析。

2014年4月7日-2016年7月19日,共招募了564位患者,随机分至rucaparib组(375人)或安慰剂组(189人)。中位随访28.1个月(IQR 22.0-33.6)。在意向治疗人群中,rucaparib组和安慰剂组的中位CFI分别为14.3个月(95% CI 13·0–17·4)和8.8个月(8.0–10.3;风险比[HR]0.43[95% CI 0.35-0.53];p<0.0001),中位TFST分别是12.4个月(11.1-15.2)和7.2个月(6.4-8.6;HR 0.43[0.35-0.52];p<0.0001),中位PFS2分别是21.0个月(18.9–23.6)和16.5个月(15.2–18.4; HR 0.66 [0.53–0.82]; p=0.0002),中位TSST分别是22.4个月 (19.1–24.5)和17.3个月(14.9–19.4;HR 0.68[0.54–0.85]; p=0.0007)。对于携带BRCA突变和同源重组修复缺陷队列,Rucaparib组的CFI、TFST、PFS2和TSST也明显长于安慰剂组。最常见的需紧急治疗的3级及以上的不良反应是贫血或血红蛋白降低(rucaparib组 22% vs 安慰剂组 1%)。重度需紧急治疗的不良反应见于rucaparib组22%的患者和安慰剂组11%的患者。既往报道了两例治疗相关死亡;本次分析未增加新的治疗相关死亡病例。

在本次中位随访超过2年的探索性分析中,rucaparib维持治疗可明显延迟后续开始治疗的时间,并且在所有三个分析组中与安慰剂相比提均有明显统计学差异。最新的安全性评估与既往报道一致。

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    2020-09-14 howi
  2. 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    2020-06-27 smlt2008
  3. 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  4. [GetPortalCommentsPageByObjectIdResponse(id=1830683, encodeId=d93d183068338, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, 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 14 09:35:28 CST 2020, time=2020-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1898049, encodeId=84c1189804998, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Sat Jun 27 22:35:28 CST 2020, time=2020-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1737641, encodeId=46f11e3764106, content=<a href='/topic/show?id=292f965e5b5' target=_blank style='color:#2F92EE;'>#铂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96575, encryptionId=292f965e5b5, topicName=铂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca4034296500, createdName=ms3153534357578991, createdTime=Sun Dec 27 01:35:28 CST 2020, time=2020-12-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865844, encodeId=5e9b186584478, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sun Jun 14 12:35:28 CST 2020, time=2020-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1909823, encodeId=6eed1909823c5, content=<a href='/topic/show?id=8f1f42518d8' target=_blank style='color:#2F92EE;'>#复发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42518, encryptionId=8f1f42518d8, topicName=复发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Fri Sep 04 10:35:28 CST 2020, time=2020-09-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2028328, encodeId=cd652028328b8, content=<a href='/topic/show?id=17f49658403' target=_blank style='color:#2F92EE;'>#铂敏感性#</a>, beContent=null, objectType=article, channel=null, 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href='/topic/show?id=b97d425286c' target=_blank style='color:#2F92EE;'>#复发性卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42528, encryptionId=b97d425286c, topicName=复发性卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec9955, createdName=windight, createdTime=Thu Jun 11 14:35:28 CST 2020, time=2020-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1388513, encodeId=4932138851332, content=<a href='/topic/show?id=7ef25e5346b' target=_blank style='color:#2F92EE;'>#敏感性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57534, encryptionId=7ef25e5346b, topicName=敏感性)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJnkE6UvGFfMS41qV0RicWvVTTeLMicqibeZH5GqO4YhNicyl1Y9jFhylIUBn9ntPYy9jhk5hrfic5cRYw/132, createdBy=5f822500020, createdName=ms5236388012055669, createdTime=Thu Jun 11 14:35:28 CST 2020, time=2020-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517118, encodeId=11f0151e11857, content=<a href='/topic/show?id=d87b2e58b8' target=_blank style='color:#2F92EE;'>#ARIEL3#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2758, encryptionId=d87b2e58b8, topicName=ARIEL3)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d44511034184, createdName=12498e8em75暂无昵称, createdTime=Thu Jun 11 14:35:28 CST 2020, time=2020-06-11, status=1, ipAttribution=)]
    2020-06-14 minlingfeng
  5. [GetPortalCommentsPageByObjectIdResponse(id=1830683, encodeId=d93d183068338, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, 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 14 09:35:28 CST 2020, time=2020-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1898049, encodeId=84c1189804998, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, 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  6. [GetPortalCommentsPageByObjectIdResponse(id=1830683, encodeId=d93d183068338, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, 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 14 09:35:28 CST 2020, time=2020-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1898049, encodeId=84c1189804998, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, 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  7. 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