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J Thorac Oncol:尼拉帕利一线维持治疗中国铂敏感的广泛期小细胞肺癌患者的3期临床试验结果

2021-05-01 Nebula MedSci原创

尼拉帕利作为维持疗法,适度改善了铂敏感的ES-SCLC患者的PFS

最新的流行病学分析显示,肺癌是中国年龄标准化发病率第二高(35.1例/10万人)的癌症,且死亡率最高(30.9例/10万人)。2010年-2014年的中国肺癌患者的5年存活率为19.8%。

ZL-2306-005是一项随机、双盲、多中心的3期研究,旨在评估PARP抑制剂尼拉帕利(niraparib)用作中国铂敏感的广泛期小细胞肺癌(ES-SCLC)患者一线维持治疗的有效性和安全性。

该研究将经标准化的、以铂类为基础的、一线化疗后获得完全/部分缓解(CR/PR)的患者随机分成了两组(2:1),予以尼拉帕利或安慰剂(300 mg[基线体重≥77 kg,血小板计数≥150000/μL]或200 mg),每日1次,直至病情进展或出现不可接受的毒性反应。主要终点为无进展生存期(PFS)和总生存期(OS)。次要终点包括调查员评估的PFS和安全性。

由于ES-SCLC治疗环境的改变,ZL-2306-005试验被提前终止(数据截止时间:2020年3月20日)。2018年7月至2020年2月期间,筛查的272名患者中有185名被随机分至两组(尼拉帕利组:n=125[CR=1,PR=124];安慰剂:n=60[CR=1,PR=59])。

主要终点PFS(A)和OS(B)

尼拉帕利组和安慰剂组的中位PFS分别为1.54个月(95%CI 1.41-2.69)和1.36个月(1.31-1.48;危险比[HR] 0.66[95%CI 0.46-0.95];p=0.0242),中位OS分别为9.92个月(9.33-13.54)和11.43个月(9.53-未达到;HR 1.03[95%CI 0.62-1.73];p=0.9052)。调查者评估的PFS中位数分别为1.48个月(1.41-2.56)和1.41个月(1.31-2.00;HR 0.88[95%CI 0.61-1.26];p=0.4653)。

不良事件

尼拉帕利组和安慰剂组≥3级的不良事件发生率分别为34.4%和25.0%。

综上所述,ZL-2306-005未到达主要终点。然而,尼拉帕利作为维持疗法,适度改善了铂敏感的ES-SCLC患者的PFS,耐受性良好,且没有新的安全信号

原始出处:

Ai Xinghao,Pan Yueyin,Shi Jianhua et al. Efficacy and Safety of Niraparib as Maintenance Treatment in Patients with Extensive-Stage Small Cell Lung Cancer after First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study. J Thorac Oncol, 2021, undefined: undefined. https://doi.org/10.1016/j.jtho.2021.04.001

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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037841, encodeId=1743103e841c6, content=JTO上有很多不错的好文章,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Sat May 01 23:20:10 CST 2021, time=2021-05-01, status=1, ipAttribution=)]
    2021-08-18 minlingfeng
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  5. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037841, encodeId=1743103e841c6, content=JTO上有很多不错的好文章,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Sat May 01 23:20:10 CST 2021, time=2021-05-01, status=1, ipAttribution=)]
    2021-07-03 yyj062
  6. 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  7. 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  9. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037841, encodeId=1743103e841c6, content=JTO上有很多不错的好文章,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Sat May 01 23:20:10 CST 2021, time=2021-05-01, status=1, ipAttribution=)]
    2021-05-02 SR~young海东

    战胜病魔

    0

  10. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037841, encodeId=1743103e841c6, content=JTO上有很多不错的好文章,谢谢梅斯及时上新, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Sat May 01 23:20:10 CST 2021, time=2021-05-01, status=1, ipAttribution=)]
    2021-05-01 肿瘤克星

    JTO上有很多不错的好文章,谢谢梅斯及时上新

    0

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多发性骨髓瘤(MM)是一种以恶性浆细胞克隆增殖为特征的恶性血液系统疾病,发病率次于非霍奇金淋巴瘤,为第三大血液系统恶性肿瘤。大多数患者面临复发或药物反应较差的困境,而维持治疗为其治疗关键之一。随着新药的不断应用,来那度胺(Lenalidomide,Revlimid?)在MM全程治疗中展现出显着的疗效及安全性。

Lancet oncol:3期随机试验:延长高危型横纹肌肉瘤患者的维持治疗的利弊

30多年来,欧洲横纹肌肉瘤的标准治疗包括6个月的化疗。延长维持化疗是否可提高高风险横纹肌肉瘤患者的存活率?本研究对此进行探究。本研究是一个多中心的开放性随机对照的III期试验,招募6个月-21岁大小的高复发风险的横纹肌肉瘤患者。标准治疗后缓解的患者被随机(1:1)分至两组:停止治疗或继续维持化疗(6个疗程)。主要评估指标是无病存活率,次要指标是总体存活率和毒性。2006年4月20日-2016年12

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