J Clin Oncol:长春新碱+伊立替康联合或不联合替莫唑胺治疗儿童和成人复发或难治性横纹肌肉瘤的疗效:随机II期研究

2021-08-04 yd2015 MedSci原创

长春新碱+伊立替康联合替莫唑胺可改善复发或难治性横纹肌肉瘤患者的预后,并且毒性可耐受。VIT可作为新的治疗手段。

横纹肌肉瘤(RMS)出现复发时一般也就意味着难治性的出现,导致较差的生存(OS)。近期,欧洲研究团队开展了II期研究VIT-0910,评估长春新碱+伊立替康联合或不联合替莫唑胺治疗复发或难治性横纹肌肉瘤的疗效和安全性。相关结果发表在Journal of Clinical Oncology杂志上。

VIT-0910研究是一项国际、开放标签、随机II期试验。主要研究终点为2周期后的客观缓解率(ORR),次要研究终点为PFS、OS和不良事件。

研究纳入120例患者,两组分别为60例。中位年龄为11岁(range, 0.75-45)。长春新碱+伊立替康联合替莫唑胺(VIT)和不联合替莫唑胺(VI)组的ORR分别为44% (24/55) 和31% (18 /58) (校正OR=0.50; 95% CI, 0.22 to 1.12; P=0.09)。

VIT组较VI组明显延长患者的总生存(OS)(校正HR=0.55; 95% CI, 0.35 to 0.84; P=0.006),以及有所改善患者的PFS(校正HR =0.68; 95% CI, 0.46 to 1.01; P=0.059)。进行敏感性分析时,PFS有统计学差异 (adjusted-HR=0.64; 95% CI, 0.42 to 0.98; P=0.039),OS仍持续有统计学差异(adjusted HR=0.59; 95% CI, 0.37 to 0.93; P=0.02)。VIT组中位治疗周期数为6 (range 1-18) ,而VI组为4 (range 1-26)。

                PFS和OS

VIT组和VI组的≥3级不良事件比例分别为98%和78%,有显著统计学差异(p=0.009)。同样,对于任何级别不良事件来说,VIT组较VI组明显增加。两组研究治疗相关AE也是有差异的(93% v 69%; P=0.002)。对于严重的AE来说,VIT组也是较VI组明显增加(93% v 69%; P=0.002)。VIT组的血液学毒性明显增加(81% v 61%; P=0 .025)。胃肠道不良事件中, ≥3级腹泻 (24% v 17%; P=0.33)和恶心呕吐(26% v 17%; P=0.24) 没有统计学差异。没有治疗相关死亡事件出现。

            不良事件

综上:长春新碱+伊立替康联合替莫唑胺可改善复发或难治性横纹肌肉瘤患者的预后,并且毒性可耐受。VIT可作为新的治疗手段。

原始出处:

Defachelles AS, Bogart E, Casanova M, et al. Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial. J Clin Oncol. 2021 Aug 3:JCO2100124. doi: 10.1200/JCO.21.00124. Epub ahead of print. PMID: 34343032.

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    2021-10-21 minlingfeng
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    2021-08-06 freve
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    2021-08-05 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2021-08-05 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1971776, encodeId=695e19e1776b5, content=<a href='/topic/show?id=377096965f6' target=_blank style='color:#2F92EE;'>#长春新碱#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96965, encryptionId=377096965f6, topicName=长春新碱)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=644e456, createdName=vera_1203, createdTime=Fri Nov 05 23:01:40 CST 2021, time=2021-11-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1866180, encodeId=64d1186618054, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Thu Oct 21 16:01:40 CST 2021, time=2021-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528780, encodeId=b84c1528e80f4, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Fri Aug 06 12:01:40 CST 2021, time=2021-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033075, encodeId=97cc10330e56a, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Aug 05 00:01:40 CST 2021, time=2021-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1038385, encodeId=ad12103838557, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Aug 05 00:01:40 CST 2021, time=2021-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039046, encodeId=33cf10390466c, content=高质量研究,读起来真爽,谢谢梅斯, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿瘤克星, createdTime=Thu Aug 05 00:01:40 CST 2021, time=2021-08-05, status=1, ipAttribution=)]
    2021-08-05 肿瘤克星

    高质量研究,读起来真爽,谢谢梅斯

    0