Lancet Haematol:鲁索替尼治疗真性红细胞增多症的5年随访结果

2022-05-25 MedSci原创 MedSci原创

鲁索替尼可作为无脾肿大的控制欠佳的真性红细胞增多症患者的二线治疗选择

真性红细胞增多症是一种骨髓增生性肿瘤,其特征是Janus激酶 (JAK) 和转录信号的信号换能器和激活剂过度激活,临床表现为疲劳、盗汗、体重减轻、发烧、瘙痒。患者生活治疗差,晚期可发生脾肿大和血栓栓塞等并发症,还可进展成继发性骨髓纤维化。

RESPONSE-2研究是一项随机、开放标签的3b期试验,其初步研究结果显示,在无脾肿大的控制欠佳的真性红细胞增多症患者中,与目前最佳可用治疗相比,第28周时,JAK1和JAK2抑制剂鲁索替尼在实现主要终点红细胞压积控制方面具有显著优势。本文报告了该试验随访5年后的次要终点结果。

年满18岁、无脾肿大、对羟基脲不敏感或耐药、ECOG表现状态≤2的真性红细胞增多症患者被随机(1:1)分成两组,接受鲁索替尼(起始剂量 10mg*2/天)或最佳可用疗法治疗长达80周。第28周后,如果最佳治疗组的患者未达到主要终点或不能耐受最佳可以疗法可交叉至鲁索替尼组。鲁索替尼组坚持到第80周的患者(包括交叉而来的患者)可继续接受鲁索替尼治疗至260周。第260周时进行次要终点分析,包括持续性红细胞压积控制率、中位红细胞压积控制持续时间、中位红细胞压积水平随时间的变化、抽血次数和总生存率。


两组持久的红细胞压积控制率

2014年3月25日-2015年2月11日,共有149位患者被随机分至鲁索替尼组(n=47)或最佳治疗组(n=75)。中位随访了67个月。第28周至第80周期间,最佳治疗组75位患者中有58位(77%)交叉至了鲁索替尼组;第80周后,没有患者继续接受最佳治疗。有97位患者接受鲁索替尼治疗至260周,包括鲁索替尼组原有的59位(80%)和交叉而来的38位(66%)。


各组的总生存率和无事件生存率

第260周时,鲁索替尼组74位患者中有16位(22%)获得了持久的红细胞压积控制,估计的中位持续时间未达到。因为在第80周时应答患者少,最佳治疗组没有报告患者红细胞压积控制的中位持续时间。在5年随访期间,鲁索替尼组患者的中位红细胞压积水平保持在45%以下。鲁索替尼组患者260周内需要进行60次抽血,而最佳治疗组80周内需要进行106次抽血。鲁索替尼组和最佳治疗组的5年总生存率分别是96%和91%。


各组不良事件的发生情况

鲁索替尼组和最佳治疗组最常见的3-4级不良事件有高血压(2.4% vs 5.6%)、血小板减少症(0.3% vs 5.6%)和血小板增多症(0 vs 7.5%)。在研究期间,无治疗相关死亡发生。

综上,RESPONSE-2研究的5年随访结果支持,采用鲁索替尼作为无脾肿大的控制欠佳的真性红细胞增多症患者的二线治疗选择

 

原始出处:

Passamonti Francesco,Palandri Francesca,Saydam Guray et al. Ruxolitinib versus best available therapy in inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): 5-year follow up of a randomised, phase 3b study.[J] .Lancet Haematol, 2022, https://doi.org/10.1016/S2352-3026(22)00102-8.

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GetPortalCommentsPageByObjectIdResponse(id=1222399, encodeId=8d3c12223997b, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Wed May 25 20:18:45 CST 2022, time=2022-05-25, status=1, ipAttribution=)]
    2022-07-06 changfy
  4. 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  5. 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GetPortalCommentsPageByObjectIdResponse(id=1222399, encodeId=8d3c12223997b, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Wed May 25 20:18:45 CST 2022, time=2022-05-25, status=1, ipAttribution=)]
    2022-06-27 ms8000000019957998

    这国内有卖吗?

    0

  6. 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  7. 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createdName=维他命, createdTime=Mon Nov 14 23:06:38 CST 2022, time=2022-11-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2008586, encodeId=2bc72008586e4, content=<a href='/topic/show?id=1066844469' target=_blank style='color:#2F92EE;'>#HAE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8444, encryptionId=1066844469, topicName=HAE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32d177, createdName=changfy, createdTime=Wed Jul 06 20:06:38 CST 2022, time=2022-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1914428, encodeId=d22719144282d, content=<a href='/topic/show?id=ecd31481c3' target=_blank style='color:#2F92EE;'>#5年随访#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1481, encryptionId=ecd31481c3, topicName=5年随访)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76fa353, createdName=tm10051981, createdTime=Wed Oct 26 05:06:38 CST 2022, time=2022-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1228970, encodeId=5f5c12289e02d, content=这国内有卖吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c5db8195891, createdName=ms8000000019957998, createdTime=Mon Jun 27 16:07:07 CST 2022, time=2022-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282106, encodeId=f1c512821067f, content=<a href='/topic/show?id=3dece71531e' target=_blank style='color:#2F92EE;'>#红细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77153, encryptionId=3dece71531e, topicName=红细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c22f171, createdName=kord1982, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317724, encodeId=22a1131e724ae, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555473, encodeId=792015554e361, content=<a href='/topic/show?id=f016e71581b' target=_blank style='color:#2F92EE;'>#红细胞增多症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77158, encryptionId=f016e71581b, topicName=红细胞增多症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a1014606284, createdName=linlin2317, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1222525, encodeId=d8d212225255b, content=<a href='/topic/show?id=23e3454e353' target=_blank style='color:#2F92EE;'>#学习#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45473, encryptionId=23e3454e353, topicName=学习)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/gKNgZiaia7XBE8lJLn1fp5u443yIhUNiaN9RztibctRREAGYVEtL7eC22wG0DzYdDiaiaTAEg4HaotaF4icegqk4VQvCA/132, createdBy=d6182579909, createdName=西瓜0628, createdTime=Thu May 26 08:30:32 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1222399, encodeId=8d3c12223997b, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Wed May 25 20:18:45 CST 2022, time=2022-05-25, status=1, ipAttribution=)]
    2022-05-26 fengyi812
  8. [GetPortalCommentsPageByObjectIdResponse(id=1831572, encodeId=73ab18315e21b, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Tue Jan 03 12:06:38 CST 2023, time=2023-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818834, encodeId=40e11818834dc, content=<a href='/topic/show?id=9687984e5e3' target=_blank style='color:#2F92EE;'>#随访结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98475, encryptionId=9687984e5e3, topicName=随访结果)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Mon Nov 14 23:06:38 CST 2022, time=2022-11-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2008586, encodeId=2bc72008586e4, content=<a href='/topic/show?id=1066844469' target=_blank style='color:#2F92EE;'>#HAE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8444, encryptionId=1066844469, topicName=HAE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32d177, createdName=changfy, createdTime=Wed Jul 06 20:06:38 CST 2022, time=2022-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1914428, encodeId=d22719144282d, content=<a href='/topic/show?id=ecd31481c3' target=_blank style='color:#2F92EE;'>#5年随访#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1481, encryptionId=ecd31481c3, topicName=5年随访)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76fa353, createdName=tm10051981, createdTime=Wed Oct 26 05:06:38 CST 2022, time=2022-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1228970, encodeId=5f5c12289e02d, content=这国内有卖吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c5db8195891, createdName=ms8000000019957998, createdTime=Mon Jun 27 16:07:07 CST 2022, time=2022-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282106, encodeId=f1c512821067f, content=<a href='/topic/show?id=3dece71531e' target=_blank style='color:#2F92EE;'>#红细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77153, encryptionId=3dece71531e, topicName=红细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c22f171, createdName=kord1982, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317724, encodeId=22a1131e724ae, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555473, encodeId=792015554e361, content=<a href='/topic/show?id=f016e71581b' target=_blank style='color:#2F92EE;'>#红细胞增多症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77158, encryptionId=f016e71581b, topicName=红细胞增多症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a1014606284, createdName=linlin2317, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1222525, encodeId=d8d212225255b, content=<a href='/topic/show?id=23e3454e353' target=_blank style='color:#2F92EE;'>#学习#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45473, encryptionId=23e3454e353, topicName=学习)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/gKNgZiaia7XBE8lJLn1fp5u443yIhUNiaN9RztibctRREAGYVEtL7eC22wG0DzYdDiaiaTAEg4HaotaF4icegqk4VQvCA/132, createdBy=d6182579909, createdName=西瓜0628, createdTime=Thu May 26 08:30:32 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1222399, encodeId=8d3c12223997b, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Wed May 25 20:18:45 CST 2022, time=2022-05-25, status=1, ipAttribution=)]
  9. [GetPortalCommentsPageByObjectIdResponse(id=1831572, encodeId=73ab18315e21b, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Tue Jan 03 12:06:38 CST 2023, time=2023-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818834, encodeId=40e11818834dc, content=<a href='/topic/show?id=9687984e5e3' target=_blank style='color:#2F92EE;'>#随访结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98475, encryptionId=9687984e5e3, topicName=随访结果)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, 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attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c22f171, createdName=kord1982, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317724, encodeId=22a1131e724ae, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Thu May 26 12:06:38 CST 2022, time=2022-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555473, encodeId=792015554e361, content=<a href='/topic/show?id=f016e71581b' target=_blank style='color:#2F92EE;'>#红细胞增多症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, 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GetPortalCommentsPageByObjectIdResponse(id=1222399, encodeId=8d3c12223997b, content=认真学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6EF3hKja8nER8RMzxQdria9eCYFhgLTLsDOeqnvIYdeLDz5eP6EnicLuE5gibiawgno4zUA0jAR7Nbtp2llQ9fs3Mk/0, createdBy=278f1986883, createdName=医鸣惊人, createdTime=Wed May 25 20:18:45 CST 2022, time=2022-05-25, status=1, ipAttribution=)]
    2022-05-26 西瓜0628
  10. [GetPortalCommentsPageByObjectIdResponse(id=1831572, encodeId=73ab18315e21b, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Tue Jan 03 12:06:38 CST 2023, time=2023-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818834, encodeId=40e11818834dc, content=<a href='/topic/show?id=9687984e5e3' target=_blank style='color:#2F92EE;'>#随访结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98475, encryptionId=9687984e5e3, topicName=随访结果)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, 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    2022-05-25 医鸣惊人

    认真学习了

    0

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