J Clin Oncol:Andecaliximab联合mFOLFOX6方案作为晚期胃/胃食管交界腺癌的一线疗法的3期试验结果

2021-02-22 MedSci原创 MedSci原创

Andecaliximab(ADX)是一种能抑制基质金属蛋白酶9的单克隆抗体。

基质金属蛋白酶9是一种参与基质重塑、肿瘤生长和转移的细胞外酶。Andecaliximab(ADX)是一种能抑制基质金属蛋白酶9的单克隆抗体。一项I期和Ib期的研究显示,改良的奥沙利铂(oxaliplatin)、亚叶酸和氟尿嘧啶(mFOLFOX6)联合ADX用于胃或胃食管交界处(GEJ)腺癌患者可展现出令人鼓舞的抗肿瘤活性。

本研究是一项随机、双盲、安慰剂(PBO)为对照的多中心III期研究,旨在评估mFOLFOX6联合或不联合ADX治疗未治疗过的人表皮生长因子受体2阴性胃癌或GEJ腺癌的疗效和安全性。将受试者1:1随机分至两组,接受mFOLFOX6+ADX或mFOLFOX6+PBO治疗。在每28天周期的第1天和第15天静脉滴注ADX/PBO 800 mg,持续治疗到疾病进展或不耐受为止。主要终点是总生存期(OS),次要终点是无进展生存期(PFS)、客观有效率(RECIST1.1)和安全性。

治疗亚组间的预后

2015年9月-2017年5月,432名患者被随机分组:218名患者接受ADX治疗,214名患者接受PBO治疗。ADX组和PBO组的中位OS分别为12.5个月和11.8个月。ADX组和PBO组的中位PFS分别为7.5个月和7.1个月。ADX组和PBO组的客观有效率分别为51%和41%。

65岁上下患者预后

在亚组分析中,ADX组65岁及以上的患者的OS和PFS也明显优于PBO组。ADX组和PBO组的安全性没有显著差异。

综上,对未经选择的未治疗过的人表皮生长因子受体2阴性的胃癌或GEJ腺癌患者中,mFOLFOX6方案额外加入ADX并不能改善OS。

原始出处:

Shah Manish A,Bodoky Gyorgy,Starodub Alexander et al. Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1). J Clin Oncol, 2021, 10.1200/JCO.20.02755.

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    2021-04-02 gostraight
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    2022-01-20 minlingfeng
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createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Tue Feb 23 00:58:31 CST 2021, time=2021-02-23, status=1, ipAttribution=)]
    2021-10-03 snf701207
  5. 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createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Tue Feb 23 00:58:31 CST 2021, time=2021-02-23, status=1, ipAttribution=)]
    2021-02-24 zhouqu_8
  6. 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createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Tue Feb 23 00:58:31 CST 2021, time=2021-02-23, status=1, ipAttribution=)]
    2021-02-24 linlin2314
  7. 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createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Tue Feb 23 00:58:31 CST 2021, time=2021-02-23, status=1, ipAttribution=)]
  8. 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    2021-02-23 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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