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Lancet Oncol:标准一线化疗方案加Nintedanib治疗晚期卵巢癌效果显著

2015-11-16 崔倩 译 MedSci原创

血管生成是治疗卵巢癌的靶点。Nintedanib,一种VEGF受体,血小板衍生的生长因子受体,成纤维细胞生长因子受体的口服三联血管激酶抑制剂,已经在2期试验中显示出活性。该研究nintedanib联合标准卡铂和紫杉醇化疗相结合治疗新诊断的晚期卵巢癌患者。在这项双盲3期临床试验中,患有国际妇产科联合会(FIGO)IIB-IV期卵巢癌并通过前期细胞减灭术化疗初治的患者(年龄在18岁或以上),通过术后切

血管生成是治疗卵巢癌的靶点。Nintedanib,一种VEGF受体,血小板衍生的生长因子受体,成纤维细胞生长因子受体,口服三联血管激酶抑制剂,已经在2期试验中显示出活性。该研究评估了nintedanib联合标准卡铂和紫杉醇化疗治疗新诊断的晚期卵巢癌患者。

在这项双盲的3期临床试验中,患有国际妇产科联合会(FIGO)IIB-IV期卵巢癌并通过前期细胞减灭术化疗初治的患者(年龄在18岁或以上),通过术后切除的状态、临床分期、和计划的卡铂剂量进行分层。患者被随机分配(2:1)通过交互式语音或基于网络的响应系统接受六个周期卡铂(AUC 5mg/mL/min或6mg/mL/min)和紫杉醇(175mg/m2),此外还要加上200mg的nintedanib(nintedanib组)或安慰剂(安慰剂组),每3周的周期中2-21天每天两次,长达120周。患者、调查员和独立放射评审都不知道治疗分配。主要终点是研究者评估的无进展生存期,在意向治疗人群中进行分析。

在2009年12月9日和2011年7月27日之间,1503例患者进行了筛选,22个国家九个研究组的1366例患者被随机分配:nintedanib组911例,安慰剂组455例。nintedanib组的486(53%)患者经历了疾病进展或死亡,安慰剂组中266例患者(58%)经历了疾病进展或死亡。nintedanib组的中位无进展生存期显著长于安慰剂组(17.2个月[95%Cl 16.6-19.9 vs 16.6个月[13.9-19.1];危险比0.84 [95%Cl 0.72-0.98];P=0.024)。

最常见的不良反应表现在胃肠道(腹泻:nintedanib组902例3级患者中的191例[21%]和3例[<1%]4级 vs 安慰剂组450例中的9例[2%]只有3级)和血液(粒细胞减少症:nintedanib组180例3级[20%]和200例4级(22%) vs 安慰剂组90例3级[20%]和72例4级[16%];血小板减少:105[12%]和55[6%] vs 21[5%]和8[2%];贫血:108 [12%]和13[1%] vs 26[6%]和5[1%])。严重不良事件的报告中nintedanib组902例患者中有376(42%)例,安慰剂组450例中的155例(34%)。nintedanib组902例患者中的29例(3%)经历了与死亡相关的严重不良事件,在安慰剂组中450例患者有16(4%)例;nintedanib组中的12例(1%)和安慰剂组中的6例(1%)有恶性肿瘤进展,被研究者归为不良事件。药物相关的不良事件导致死亡发生的在nintedanib组有3例(一例没有病因诊断;一例是由于与药物有关的腹泻和肾功能衰竭的非药物性败血症;和1例腹膜炎)和安慰剂组的1例患者(原因不明)。

Nintedanib与卡铂和紫杉醇的联合用药是对晚期卵巢癌女性患者有效的一线治疗方法,能够显著增加无进展生存期,但会造成更多的胃肠道不良事件。今后的研究应着眼于提高病人的选择和耐受性的优化。

原始出处:

Andreas du Bois,Gunnar Kristensen,Isabelle Ray-Coquard,et al.Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12),Lancet Oncology.2015.11.15

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    2016-01-01 minlingfeng
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  3. [GetPortalCommentsPageByObjectIdResponse(id=1864734, encodeId=98111864e3420, 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=Fri Jan 01 18:20:00 CST 2016, time=2016-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1924691, encodeId=b5a11924691cf, content=<a href='/topic/show?id=74ed1941207' target=_blank style='color:#2F92EE;'>#一线化疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19412, encryptionId=74ed1941207, topicName=一线化疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea6321, createdName=okhuali, createdTime=Tue Feb 16 00:20:00 CST 2016, time=2016-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1828300, encodeId=5995182830063, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, 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 May 31 19:20:00 CST 2016, time=2016-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1702926, encodeId=e09e1e0292635, content=<a href='/topic/show?id=72351e25437' target=_blank style='color:#2F92EE;'>#TED#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17254, encryptionId=72351e25437, topicName=TED)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=76e230462388, createdName=aliceclz, createdTime=Sun Apr 10 01:20:00 CST 2016, time=2016-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361785, encodeId=12ef1361e85b0, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Wed Nov 18 04:20:00 CST 2015, time=2015-11-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394548, encodeId=9aa113945481a, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Wed Nov 18 04:20:00 CST 2015, time=2015-11-18, status=1, ipAttribution=)]
    2016-05-31 howi
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    2016-04-10 aliceclz
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