哎呀,您使用的是旧版本的浏览器,所以页面上的一些功能可能无法正常显示。

最低要求:谷歌Chrome 24 +Mozilla Firefox 20 +Internet Explorer 11提升歌剧苹果Safari 7SeaMonkey 2.15 - -2.23

提供论文会议-网络和内分泌肿瘤

1097年o -AXINET试验(GETNE1107):与安慰剂+ octreotide LAR相比,Axitinib + octreotide LAR通过盲法中央放射学评估改善G1-2胰腺外网患者的PFS

日期

2021年9月21日

会话

提供论文会议-网络和内分泌肿瘤

主持人

Rocio Garcia-Carbonero

引用

Annals of Oncology (2021) 32 (suppl_5): S906-S920。10.1016 / annonc / annonc678

作者

r . Garcia-Carbonero1, m . Benavent2P. Jiménez冯塞卡3.,可以见到效果4, t . Alonso-Gordoa5, a Teule6,库斯托迪奥7,美国Tafuto8拉卡斯塔(A. La Casta)9,位咨询专家10, c·洛佩兹11t·易卜拉欣12M.J. Villanueva Silva13,诉Iranzo14, p . Garcia-Alfonso15,大肠Gonzalez-Flores16,大肠格兰德17, g·克雷斯波18, a Carmona-Bayonas19, j . Capdevila20.

作者的从属关系

  • 110月12日,马德里/ES, 28041,大学医院肿瘤内科
  • 2维根德尔Rocío医院肿瘤内科,41013 -塞维利亚/ES
  • 3.阿斯图里亚斯中央大学医院肿瘤内科,33011 - Oviedo/ES
  • 410月12日大学附属医院肿瘤内科,Imas 12, 28041 -马德里/ES
  • 5马德里大学附属医院Ramón y Cajal肿瘤内科
  • 6L'Hospitalet de Llobregat/ES Català d' Oncology L'Hospitalet, L'Hospitalet de Llobregat/ES
  • 7拉巴斯大学医院肿瘤科,马德里28046 /ES
  • 8帕斯卡尔国家癌症研究所肿瘤内科,80131 -那不勒斯/IT
  • 9多诺斯蒂亚大学医院肿瘤内科,20014 - San Sebastián/ES
  • 10医学肿瘤学,欧洲肿瘤研究所,米兰/IT
  • 11桑坦德大学Marqués de Valdecilla医院肿瘤科
  • 12Tumori Rari E Testa-collo Dept., IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)“Dino Amadori”,47014 - Meldola/IT
  • 13维戈/ES医院Álvaro Cunqueiro
  • 14巴伦西亚综合大学医院肿瘤科,巴伦西亚/ES
  • 15格雷戈里奥大学医院肿瘤内科Marañón,马德里/ES
  • 16拉斯尼夫斯大学医院肿瘤内科,18014 -格拉纳达/ES
  • 17医学肿瘤科,MD安德森癌症中心马德里,28033马德里/ES
  • 18布尔戈斯大学附属医院肿瘤内科
  • 19莫拉莱斯大学医院肿瘤内科,30008 -穆尔西亚/ES
  • 20.瓦尔德希布伦大学医院肿瘤研究所胃肠和内分泌肿瘤科,巴塞罗那8035 /ES
更多的

资源

文摘1097度

背景

血管新生在NET的发展和进展中起着重要的作用。阿西替尼是一种有效的、选择性的vegfr -1,2,3抑制剂,被证实对其他血管依赖的实体肿瘤具有活性。这项双盲II/III期随机研究的目的是评估阿西替尼对晚期G1-2型胰外NETs患者(pts)的疗效。

方法

患者随机1:1接受奥曲肽LAR (30 mg IM q4w)与阿西替尼(5 mg BID)或安慰剂BID,直到疾病进展或毒性不可接受。根据从诊断到进入研究的时间(>或≤12m)、原发肿瘤位置(胃肠道vs非胃肠道)和Ki-67指数(≤5% vs > 5%)进行随机分层。允许使用SSA、IFN和多达2种全身治疗,但不允许使用VEGF或vegfr靶向药物。研究开始前12个月内的临床和/或放射疾病进展情况。主要终点为无进展生存期(PFS)。研究人员每项评估的PFS结果在ASCO GI 2021年提交。现在提出了无进展生存率的盲法独立中央评估。

结果

256名患者被纳入,126名随机接受阿西替尼,130名随机接受安慰剂(G1-2: 29%-71%)。最常见的原发肿瘤部位为SI(47%)、肺(28%)、直肠(6%)、UK(8%)、胃(3%)和结肠(2%)。既往治疗包括SSA(48%)、依维莫司(13%)、化疗(13%)、LR tx(7%)和PRRT(3%)。在接受阿西替尼治疗的患者中,每项独立放射学评估的ORR显著高于安慰剂(13.2% vs 3.2%, p=0.0045)。每项盲法独立中心研究的PFS也显著有利于阿西替尼治疗的患者(阿西替尼组与安慰剂组的中位PFS分别为16.6个月和9.9个月,HR为0.687,p=0.01)。正如之前报道的那样,毒性是可控的(ASCO GI 2021)。

结论

根据对治疗分配盲的独立放射学评估,阿西替尼联合奥曲肽LAR治疗晚期进行性G1-2胰腺外NETs患者的PFS显著改善,且具有可耐受的安全性。

临床试验鉴定

NCT01744249。

社论承认

Daniela Morales-Espinosa医学博士,理学硕士

负责研究的法人实体

(Grupo Español de tummores Neuroendocrinos)。

资金

辉瑞。

信息披露

R.加西亚Carbonero:财务利益,个人,议长局,科学建议:AAA;财务利益,个人,议长局,科学建议:Advanz医药;财务利益,个人,议长局,科学建议:德国拜耳;财务利益,个人,议长局,科学建议:BMS;财务利益,个人,议长局,科学建议:HMP;财务利益,个人,议长局,科学咨询:易普森;财务利益,个人,议长局,科学建议:默克公司:财务利益,个人,议长局,科学建议:Midatech医药;财务利益,个人,议长局,科学建议:MSD;财务利益,个人,议长局,科学建议:诺华公司; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: PharmaMar; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Pfizer; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Roche; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Sanofi; Financial Interests, Personal, Speaker’s Bureau, Scientific advice: Servier; Financial Interests, Personal, Funding, Financial support to IIT evaluating Axitinib in NETs: Pfizer; Financial Interests, Personal, Funding, Financial support to IIT evaluating Nivolumab in NECs: BMS; Financial Interests, Personal, Funding, Financial support to IIT evaluating Pembrolizumab-Olaparib in CRC: MSD; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: ARMO Biosciences; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Astra Zeneca; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Pfizer; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Novartis; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Ipsen; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Roche; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Pharmacyclics; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Boston Biomedicals; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Merck; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: MSD; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Amgen; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Sanofi; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Bayer; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Bristol-Myers-Squibb; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Boerhinger Ingelheim; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Sysmex; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Gilead Sciences; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Servier; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Adacap; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: VCN; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: Lilly; Financial Interests, Institutional, Funding, Financial support for the conduct of clinical trials or for molecular diagnostic platforms: PharmaMar; Non-Financial Interests, Personal, Leadership Role, Member of the executive committee: GETNE (Spanish Neuroendocrine Tumor Cooperative Group; Non-Financial Interests, Personal, Leadership Role, Member of the executive committee: ENETS; Non-Financial Interests, Personal, Principal Investigator, Global PI of clinical trial of Axitinib in NETs: Pfizer; Non-Financial Interests, Personal, Principal Investigator, Global PI of clinical trial of nivolumab and chemotherapy in NETs: BMS; Non-Financial Interests, Personal, Principal Investigator, Global PI of clinical trial of pembrolizumab-olaparib in CRC: MSD; Non-Financial Interests, Personal, Member: EORTC; Non-Financial Interests, Personal, Member: ASCO; Non-Financial Interests, Personal, Member: ESMO; Non-Financial Interests, Personal, Member: SEOM; Non-Financial Interests, Personal, Member: TTD; Non-Financial Interests, Personal, Member: GEMCAD. M. Benavent: Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: PFIZER; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: ROCHE; Financial Interests, Personal, Principal Investigator: Novartis; Financial Interests, Personal, Principal Investigator: Ipsen. D. Castellano: Financial Interests, Personal, Invited Speaker: full DOI at ESMO profile. T. Alonso-Gordoa: Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Ipsen; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Astellas; Financial Interests, Personal, Advisory Role: Janssen-Cilag; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: BMS; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Eisai; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Institutional, Principal Investigator: Roche; Financial Interests, Institutional, Principal Investigator: Astra Zeneca; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Eisai; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: Ipsen; Financial Interests, Institutional, Principal Investigator: GSK-Novartis; Financial Interests, Institutional, Principal Investigator: Clovis; Financial Interests, Institutional, Principal Investigator: Nektar Therapeutics; Financial Interests, Institutional, Principal Investigator: Janssen-Cilag; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: Bayer; Non-Financial Interests, Institutional, Project Lead: Pfizer; Non-Financial Interests, Institutional, Project Lead: Roche; Non-Financial Interests, Institutional, Project Lead: Ipsen. A. Teulé: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Astra Zeneca; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Advisory Role: Astra Zeneca; Financial Interests, Personal, Advisory Role: AAA; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Other, Travel grants: Novartis; Financial Interests, Personal, Other, Travel grants: Ipsen; Financial Interests, Personal, Other, Travel grants: Astra Zeneca; Financial Interests, Personal, Other, Travel grants: AAA; Financial Interests, Personal, Other, Travel grants: Pfizer. A. Custodio: Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: IPSEN; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Pfizer; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Novartis; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: MSD; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: BMS; Financial Interests, Personal, Invited Speaker, Consultancy or advisory role: Lilly; Financial Interests, Institutional, Principal Investigator: Ipsen; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: EISAI; Financial Interests, Institutional, Principal Investigator: Astra Zeneca; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: BeiGene; Non-Financial Interests, Personal, Leadership Role, Member of the GETNE tumor board: GETNE. S. Tafuto: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Principal Investigator: Ipsen; Financial Interests, Personal, Principal Investigator: Roche; Financial Interests, Personal, Principal Investigator: PFIZER; Financial Interests, Personal, Principal Investigator: Novartis. F. Spada: Financial Interests, Personal, Advisory Board, Travel grant: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Other, Travel grant: Pfizer; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Institutional, Principal Investigator: GETNE; Financial Interests, Institutional, Principal Investigator: Incyte; Financial Interests, Institutional, Principal Investigator: MSD; Non-Financial Interests, Personal, Leadership Role, Coordinator of Neuroendocrine Neoplasms guidelines: Italian Association of Medical Oncology (AIOM); Non-Financial Interests, Personal, Leadership Role, Executive board meamber: Italian Association of Neuroendocrine Tumors (ITANET). C. López: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: AAA; Non-Financial Interests, Personal, Principal Investigator: Ipsen; Non-Financial Interests, Personal, Principal Investigator: ROCHE; Non-Financial Interests, Personal, Principal Investigator: Pfizer; Non-Financial Interests, Personal, Principal Investigator: Novartis. T. Ibrahim: Financial Interests, Personal, Other, Consultancy: EISAI; Financial Interests, Personal, Other, Consultancy: Amgen; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Other, Travel grant: Ipsen; Financial Interests, Personal, Other, Travel grant: Pharmamar; Financial Interests, Personal, Other, Travel grant: Novartis. M.J. Villanueva Silva: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Glaxo-Smithkline; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Pfizer; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Roche; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Novartis; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Sanofi; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Celgene; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: AstraZeneca; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: BMS; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Merck Serono; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Merck Sharp and Dohme; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Janssen-Cilag; Financial Interests, Institutional, Funding, Institutional research funding for conducting phase II and III clinical trials: Bayer. V. Iranzo: Financial Interests, Personal, Advisory Board: Advanced Accelerator Applications; Financial Interests, Personal, Invited Speaker: Astra Zeneca; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Genomic Health; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche. P. García-Alfonso: Financial Interests, Personal, Invited Speaker: Ipsen. E. González-Flores: Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: AAA; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis. E. Grande: Financial Interests, Personal, Invited Speaker: Adecap; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Invited Speaker: Astra Zeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board: Caris Life Sciences; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Eusa Pharma; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Merck KGa; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: ONCODNA (Biosequence); Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Sanofi-Genzyme; Non-Financial Interests, Institutional, Research Grant: Astellas; Non-Financial Interests, Institutional, Research Grant: Astra Zeneca; Non-Financial Interests, Institutional, Principal Investigator: Ipsen; Non-Financial Interests, Institutional, Research Grant: Lexicon; Non-Financial Interests, Institutional, Research Grant: MTEM/Threshold; Non-Financial Interests, Institutional, Research Grant: Nanostring Technologies; Non-Financial Interests, Institutional, Research Grant: Pfizer; Non-Financial Interests, Institutional, Research Grant: Roche. G. Crespo: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: IPSEN; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: EISAI; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: EUSA Pharma; Financial Interests, Personal, Invited Speaker: Pierre Fabre. A. Carmona-Bayonas: Financial Interests, Personal, Project Lead: Lilly; Financial Interests, Personal, Project Lead: BMS. J. Capdevila: Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Amgen; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Bayer; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: AAA; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: Eisai; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: Ipsen; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: ITM; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Hudchinson Pharma; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Lilly; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Merck; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: NOVARTIS; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker - Research grant: Pfizer; Financial Interests, Personal, Speaker’s Bureau, Advisory Board - Invited speaker: Sanofi. All other authors have declared no conflicts of interest.

本网站使用cookie。其中一些cookie是必不可少的,而另一些则通过提供网站如何被使用的见解来帮助我们改善您的体验。

有关我们使用的cookies的更详细信息,请查看我们的隐私政策

自定义设置