Cabozantinib与舒尼替尼作为中度或低风险转移性肾细胞癌的最佳治疗方案(Alliance A031203 CABOSUN随机试验):总生存期和无进展生存

2018-04-29 MedSci MedSci原创

随机II期CABOSUN试验比较了cabozantinib和舒尼替尼作为中等或低风险晚期肾细胞癌(RCC)的初始治疗方案,主要终点为符合研究者预期的无进展生存期(PFS)的改善。研究者通过独立的放射学审查委员会(IRC)评估报告PFS、ORR和总体生存期(OS)。先前未经治疗的患有IMDC标准的中度或低风险RCC患者,随机分为1:1至卡唑替尼60 mg / d或舒尼替尼50 mg / d

随机IICABOSUN试验比较了cabozantinib舒尼替尼作为中等或低风险晚期肾细胞癌(RCC)的初始治疗方案,主要终点为符合研究者预期的无进展生存期(PFS)的改善。研究者通过独立的放射学审查委员会(IRC)评估报告PFSORR和总体生存期(OS)。先前未经治疗的患有IMDC标准的中度或低风险RCC患者,随机分为11至卡唑替尼60 mg / d或舒尼替尼50 mg / d

157名患者被随机分配到cabozantinibn = 78)或舒尼替尼(n = 7811 cabozantinib与舒尼替尼组的中位PFS分别为8.6个月(95%可信区间[CI] 6.8-14.0)和5.3个月(95CI 3.0-8.2)(危险比[HR] 0.48 [95CI 0.31-0.74];双侧p = 0.0008);ORR分别为20%(95CI 12.0-30.8)和9%(95CI 3.7-17.6)。中位随访34.5个月,cabozantinib的中位OS​​26.6个月(95CI 14.6-不可估计),舒尼替尼组为21.2个月(95CI 16.3-27.4)。34级不良事件的发生率为68%(cabozantinib组),舒尼替尼组为65%。

与舒尼替尼相比,cabozantinib治疗显著延长了PFS,作为晚期RCC或中度风险的初始全身治疗。


原始出处:

Toni K. Choueiri et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. 2018 94: 115-125. doi.org/10.1016/j.ejca.

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    2018-05-01 膀胱癌
  4. 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1978674, encodeId=a9f319e86747e, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Dec 12 19:19:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1905051, encodeId=4018190505153, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, 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  6. [GetPortalCommentsPageByObjectIdResponse(id=1978674, encodeId=a9f319e86747e, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Dec 12 19:19:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1905051, encodeId=4018190505153, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, 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GetPortalCommentsPageByObjectIdResponse(id=1516012, encodeId=b9d0151601202, content=<a href='/topic/show?id=bd0152e64f1' target=_blank style='color:#2F92EE;'>#总生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52764, encryptionId=bd0152e64f1, topicName=总生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bdf610907545, createdName=12498cb5m16暂无昵称, createdTime=Tue May 01 14:19:00 CST 2018, time=2018-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1530317, encodeId=ab64153031e56, content=<a href='/topic/show?id=733a395650' target=_blank style='color:#2F92EE;'>#cabozantinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3956, encryptionId=733a395650, topicName=cabozantinib)], attachment=null, authenticateStatus=null, 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  7. [GetPortalCommentsPageByObjectIdResponse(id=1978674, encodeId=a9f319e86747e, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Wed Dec 12 19:19:00 CST 2018, time=2018-12-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1905051, encodeId=4018190505153, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, 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  8. 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  9. 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    2018-05-01 闆锋旦

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FDA批准cabozantinib用于治疗甲状腺髓样癌

       11月29日,美国食品药品监督管理局(FDA)批准了cabozantinib (Cometriq)用于治疗转移性甲状腺髓样癌,尽管该药物在临床试验中并未延长患者的总生存期。很显然,FDA对这种又名XL184的广谱激酶抑制剂在临床试验中显著的PFS(无进展生存期)益处和轻微毒性反应很满意。       &

JCO:Cabozantinib或可改善晚期前列腺癌患者PFS

       一项关于新药物cabozantinib ( Cometriq)用于去势抵抗性前列腺癌(CRPC)治疗的研究报告被称为“史无前例”。相关的研究结果在线发表在11月19日的《临床肿瘤学杂志(JCO)》上。Cabozantinib是一种口服的多受体酪氨酸激酶抑制剂,作用对象包括RET,MET,和VEGFR2,于11月29日被FDA批准用于甲状腺髓样癌

Eur J Cancer:Cabozantinib治疗卵巢癌的有效(随机停药试验)

背景:Cabozantinib(XL184)是血管内皮生长因子受体2和MET的口服抑制剂,近期来自美国的研究人员一个卵巢癌患者的2期队列研究中探讨了它的疗效和安全性,该试验是一个由九个不同类型的肿瘤组成的随机停药试验(RDT)的一部分。病人和方法:患者接受100毫克Cabozantinib,每日。那些在12周时,通过肿瘤反应评估标准判断为病情稳定(SD)的实体瘤患者接受随机分配Cabozantin

ANN ONCOL:cabozantinib治疗甲状腺髓样癌患者总生存分析

之前报道的cabozantinib治疗晚期甲状腺髓样癌的临床试验结果证明其与安慰剂相比可以显着改善患者无进展生存情况。ANN ONCOL近期发表了一篇文章,报道了长期随访后总生存情况。

Lancet Oncol:晚期肾癌VEGF靶向治疗进展后, cabozantinib成新标准?

国家卫生与护理研究所(NICE)最近发表了一项关于cabozantinib推荐使用的指导,基于目前的研究结果,cabozantinib可以作为成人晚期肾癌VEGF靶向治疗进展后的一种新的标准治疗方案。

FDA授予Exelixis公司抗癌药cabozantinib优先审查资格

Exelixis公司今天宣布,FDA已接受审查该公司抗癌药cabozantinib的新药申请(NDA),该药用于不能手术切除的恶性局部晚期或转移性髓样甲状腺癌(medullary thyroid cancer,MTC)的治疗。同时,FDA已授予该药优先审查资格(priority review designation),这意味着FDA将在6个月内完成cabozantinib NDA的审查。 在今年