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Thyroid:安罗替尼治疗甲状腺髓样癌II期临床研究结果在国际权威杂志发表

2018-08-28 肿瘤资讯编辑部 肿瘤资讯

盐酸安罗替尼作为由我国自主研发的新型口服多靶点酪氨酸激酶抑制剂,在肺癌、软组织肉瘤等领域取得了新进展。

盐酸安罗替尼作为由我国自主研发的新型口服多靶点酪氨酸激酶抑制剂,在肺癌、软组织肉瘤等领域取得了新进展。近日,安罗替尼治疗甲状腺髓样癌II期临床研究结果在国际权威杂志Thyroid发表。Thyroid是美国甲状腺学会(American Thyroid Association,ATA)官方期刊,是SCI收录的唯一一本甲状腺专科杂志,是甲状腺疾病领域国际权威的杂志,发表文章涵盖甲状腺基础和临床研究。Thyroid 最新SCI影响因子为7.557。

背景

甲状腺髓样癌(Medullary thyroid carcinoma, MTC)是甲状腺癌的一种亚型,源自甲状腺滤泡旁细胞(C细胞)。局部晚期或者已经发生远处转移的MTC患者的愈后不佳。根据是否具有遗传性,MTC可分为散发性和遗传性两大类。手术和放疗是MTC的主要治疗手段,对于疾病进展的晚期MTC患者,药物治疗是重要的治疗手段。传统的细胞毒药物对MTC的治疗效果不佳,在国内目前还没有标准的治疗方案。近期研究发现,多种激酶如血管内皮生长因子受体(VEGFR)、成纤维细胞生长因子受体(FGFR)在MTC细胞中异常表达。

安罗替尼是一种口服的新型小分子多靶点酪氨酸激酶抑制剂(TKI),可强效抑制VEGFR、血小板衍生生长因子受体(PDGFR)、FGFR和干细胞因子受体(c-Kit)等多个靶点,具有抗肿瘤血管生成和抑制肿瘤生长的双重作用。安罗替尼单药用于晚期MTC的多中心II期临床研究结果在《Thyroid》杂志上正式发表,该研究旨在评估安罗替尼单药治疗晚期MTC的疗效和安全性。

方法

从2013年7月至2014年7月,在全国8家中心招募受试者并开展安罗替尼治疗晚期甲状腺髓样癌II期临床试验。入组受试者口服安罗替尼直至进展或出现不可耐受的毒性。安罗替尼的给药方式为口服12mg,每天一次,用两周停一周,21天为一个治疗周期。每2个周期进行一次影像学评估。采用NCI的CTCAE 4.0进行不良事件(AE)分级并对受试者进行安全性评估,如患者无法耐受口服安罗替尼12mg/天,允许调整剂量至10mg/天或8mg/天。研究的主要终点为无进展生存期(PFS),次要研究终点为客观缓解率(ORR)、疾病控制率(DCR)、总生存期(OS)。

主要入组标准:

1. 经组织学明确诊断,至少有一个可测量病灶,无法切除局部晚期转移、遗传或散发的甲状腺髓样癌患者。诊断由各研究中心病理学专家完成,病理标本(肿块或切片)由独立人员确认(中心确认)。

2. 18~70岁;PS评分:0~2;预计生存期超过3月;

3. 血清降钙素≥500 pg/mL,FT4、TSH正常,甲状腺功能基本正常;

4. 实验室检查符合下列标准:

血常规检查:Hb≥100g/L(14天内未输血);ANC≥1.5×109/L;PLT≥80×109/L

生化检查:血清肌酐Cr≤正常值上限 (ULN)、胆红素BIL≤正常值上限 (ULN)、ALT、AST≤1.5×正常值上限 (ULN),对于有肝转移者≤5×正常值上限 (ULN);空腹甘油三酯≤3.0mmol/L,空腹胆固醇≤7.75mmol/L;

多普勒超声评估:左室射血分数 (LVEF) ≥正常值低限 (50%)。

5. 女性应为同意在研究期间和研究结束后6个月内必须采用避孕措施;在研究入组前的7天内血清或尿妊娠试验阴性,且必须为非哺乳期患者;男性应同意在研究期间和研究期结束后6个月内必须采用避孕措施的患者。

6. 患者自愿加入本研究,签署知情同意书,依从性好。

主要排除标准:

1. 己知的脑转移、脊髓压迫、癌性脑膜炎,或筛选时CT 或MRI 检查发现脑或者软脑膜的疾病者;

2. 存在任何重度和/未能控制的疾病的患者;

3. 长期未治愈的伤口或骨折;

4. 具有出血倾向(如活动性消化道溃疡)或应用抗凝剂或维生素K拮抗剂如华法林、肝素或其类似物治疗的患者;

5. 首次用药前发生过动/静脉血栓事件,如脑血管意外(包括暂时性缺血性发作)、深静脉血栓及肺栓塞者;

6. 具有精神类药物滥用史且无法戒除或有精神障碍者;

7. 有免疫缺陷病史,包括HIV检测阳性或患有其它获得性、先天性免疫缺陷疾病,或有器官移植史者;

8. 根据研究者的判断,有严重的危害患者安全或影响患者完成研究的伴随疾病者。

结果

在研究期间,共入组受试者为58例,入组受试者的中位年龄为46.9岁(最低22岁,最高71岁)。入组前,93.1%的受试者接受过手术治疗,25.9%的受试者接受过放疗,约90%的受试者未接受过药物治疗(图1)。90%的受试者入组时存在转移,常见的转移部位为淋巴结、肺和肝脏。所有的受试者均服用了安罗替尼,全部纳入全分析集(FAS)和安全分析集(SS)。



图1. 受试者基本特征

经最佳疗效分析,33位受试者病灶部分缓解,ORR为56.9%;54位受试者疾病稳定,DCR为93.1%(图2)。在接受安罗替尼治疗后的24周、36周和48周的疾病无进展率分别为92.2%、87.8%和84.5%。



图2. 病灶变化

截止统计分析时,大于50%的受试者未发生疾病进展,中位PFS还未达到(图3A)。接受安罗替尼治疗后的12个月、24个月和36个月的生存率分别为89.7%、78.6%和76.4%。大于50%的受试者存活,中位OS还未达到(图3B)。



图3. PFS和OS曲线

安全性方面,安罗替尼组耐受性良好,不良反应可控(图4)。主要的不良事件是手足皮肤反应、甘油三酯升高、胆固醇升高、疲劳、蛋白尿、高血压等。



图4. 不良事件统计结果

结论

本研究约90%的受试者是一线接受安罗替尼治疗。安罗替尼对局部晚期或发生转移的MTC有治疗效果,不良反应可控。安罗替尼与安慰剂对照治疗MTC的临床研究正在进行中,安罗替尼将为晚期MTC患者的靶向治疗提供新的选择。

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  3. [GetPortalCommentsPageByObjectIdResponse(id=961423, encodeId=a28596142320, content=何时用药,后期如何管理, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/0dcsJ6fSZm4RxSMEsLs4lE03XNIqZB2WRQjjx95Ufv1jnRmT5MbZAXqLyQ1uvhch1l8m13Ra3Wibm1rXyj4MMNA/132, createdBy=7c275243396, createdName=song3369, createdTime=Thu Apr 29 07:54:14 CST 2021, time=2021-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649980, encodeId=e661164998035, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Sun Mar 17 09:41:00 CST 2019, time=2019-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1822002, encodeId=dcaf182200236, content=<a href='/topic/show?id=26091021157a' target=_blank style='color:#2F92EE;'>#髓样癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102115, encryptionId=26091021157a, topicName=髓样癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=726030, createdName=Boyinsh, createdTime=Wed Jun 05 06:41:00 CST 2019, time=2019-06-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1739496, encodeId=17691e394960b, content=<a href='/topic/show?id=8041e343504' target=_blank style='color:#2F92EE;'>#研究结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73435, encryptionId=8041e343504, topicName=研究结果)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bbcd34536678, createdName=1249894fm84暂无昵称, createdTime=Thu Feb 14 23:41:00 CST 2019, time=2019-02-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652836, encodeId=5def1652836d3, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Sat Jan 19 01:41:00 CST 2019, time=2019-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=351855, encodeId=bf6035185596, content=很好的学习资料,值得借鉴,学习了,获益匪浅,感谢分享!谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/02/27/c53a212859edcad4f60a54feffff50bb.jpg, createdBy=67cf1525321, createdName=13718711b3m, createdTime=Wed Nov 07 17:19:18 CST 2018, time=2018-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524657, encodeId=496f152465e49, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Thu Aug 30 12:41:00 CST 2018, time=2018-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341616, encodeId=997a341616e0, content=数据还是挺好看, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/07/31/88b7a0fe36b7bac9361f6feb3f050afa.jpg, createdBy=674d2404499, createdName=asuraxia, createdTime=Wed Aug 29 09:26:53 CST 2018, time=2018-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341591, encodeId=d1ef341591eb, content=嗯嗯,学习学习。, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/07/16/3b24606172648eea459125cb74754afe.jpg, createdBy=6c022216608, createdName=liumin1987, createdTime=Wed Aug 29 08:36:55 CST 2018, time=2018-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341575, encodeId=97323415e56f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 29 07:39:18 CST 2018, time=2018-08-29, status=1, ipAttribution=)]
    2019-06-05 Boyinsh
  4. 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level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/02/27/c53a212859edcad4f60a54feffff50bb.jpg, createdBy=67cf1525321, createdName=13718711b3m, createdTime=Wed Nov 07 17:19:18 CST 2018, time=2018-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524657, encodeId=496f152465e49, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Thu Aug 30 12:41:00 CST 2018, time=2018-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341616, 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GetPortalCommentsPageByObjectIdResponse(id=341575, encodeId=97323415e56f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 29 07:39:18 CST 2018, time=2018-08-29, status=1, ipAttribution=)]
  5. 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level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/02/27/c53a212859edcad4f60a54feffff50bb.jpg, createdBy=67cf1525321, createdName=13718711b3m, createdTime=Wed Nov 07 17:19:18 CST 2018, time=2018-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524657, encodeId=496f152465e49, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Thu Aug 30 12:41:00 CST 2018, time=2018-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341616, 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GetPortalCommentsPageByObjectIdResponse(id=341575, encodeId=97323415e56f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 29 07:39:18 CST 2018, time=2018-08-29, status=1, ipAttribution=)]
  6. 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level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/02/27/c53a212859edcad4f60a54feffff50bb.jpg, createdBy=67cf1525321, createdName=13718711b3m, createdTime=Wed Nov 07 17:19:18 CST 2018, time=2018-11-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524657, encodeId=496f152465e49, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Thu Aug 30 12:41:00 CST 2018, time=2018-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341616, encodeId=997a341616e0, content=数据还是挺好看, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/07/31/88b7a0fe36b7bac9361f6feb3f050afa.jpg, createdBy=674d2404499, createdName=asuraxia, createdTime=Wed Aug 29 09:26:53 CST 2018, time=2018-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341591, encodeId=d1ef341591eb, content=嗯嗯,学习学习。, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/07/16/3b24606172648eea459125cb74754afe.jpg, createdBy=6c022216608, createdName=liumin1987, createdTime=Wed Aug 29 08:36:55 CST 2018, time=2018-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341575, encodeId=97323415e56f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 29 07:39:18 CST 2018, time=2018-08-29, status=1, ipAttribution=)]
    2018-11-07 13718711b3m

    很好的学习资料,值得借鉴,学习了,获益匪浅,感谢分享!谢谢

    0

  7. 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  8. 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encodeId=997a341616e0, content=数据还是挺好看, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2018/07/31/88b7a0fe36b7bac9361f6feb3f050afa.jpg, createdBy=674d2404499, createdName=asuraxia, createdTime=Wed Aug 29 09:26:53 CST 2018, time=2018-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341591, encodeId=d1ef341591eb, content=嗯嗯,学习学习。, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/07/16/3b24606172648eea459125cb74754afe.jpg, createdBy=6c022216608, createdName=liumin1987, createdTime=Wed Aug 29 08:36:55 CST 2018, time=2018-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341575, encodeId=97323415e56f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 29 07:39:18 CST 2018, time=2018-08-29, status=1, ipAttribution=)]
    2018-08-29 asuraxia

    数据还是挺好看

    0

  9. 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GetPortalCommentsPageByObjectIdResponse(id=341575, encodeId=97323415e56f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 29 07:39:18 CST 2018, time=2018-08-29, status=1, ipAttribution=)]
    2018-08-29 liumin1987

    嗯嗯,学习学习。

    0

  10. 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    2018-08-29 明月清辉

    谢谢分享,学习了

    0

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