Gastric Cancer:雷莫芦单抗(ramucirumab)治疗晚期胃癌的疗效和安全性:来自日本的上市后观察性真实世界研究

2021-06-01 yd2015 MedSci原创

日本的真实世界研究表明,雷莫芦单抗(ramucirumab)治疗晚期胃癌的疗效和安全性跟临床研究的一致。

胃癌是全球常见的恶性肿瘤之一。其发生率在亚洲国家较高,包括日本。铂类联合氟尿嘧啶类方案是不可切除胃癌常用的一线治疗方案,但是患者的生存仍较差,而且进展后的二线选择较少。目前,已有III期临床研究证明对于铂类联合氟尿嘧啶一线治疗晚期胃癌进展的患者,雷莫芦单抗(ramucirumab)单药或联合紫杉醇能够改善患者的无进展生存和总生存。因此,雷莫芦单抗(ramucirumab)联合紫杉醇被批准用于晚期胃癌的二线治疗。但是,其疗效和安全性都是基于临床研究,真实世界的数据还是很有限。因此。来自日本的研究团队开展了一项雷莫芦单抗上市后的观察性研究,旨在评估真实世界中雷莫芦单抗(ramucirumab)单药或联合治疗晚期胃癌的疗效和安全性。近期,研究成果发表在Gastric Cancer杂志上。

该研究是一项单臂、前瞻性、多中心、非干预的上市后的观察性研究。纳入日本2015年8月至2019年3月不可切除或复发胃癌患者,雷莫芦单抗首次治疗后随访12个月,收集相关不良事件和生存资料。

研究纳入687例患者,其中658例患者符合研究分析。18.7%(123/658)患者接受雷莫芦单抗单药治疗,80.9%(532/658)患者接受联合治疗。紫杉醇是常用的联合药物(528/532; 99.2%),而只有4例(0.8%)患者使用了其他药物(伊立替康、氟尿嘧啶、多西他赛、顺铂)。

雷莫芦单抗联合治疗组和雷莫芦单抗单药组中的大多数患者都出现≥ 1的不良事件(联合组:any grade, 479/528; 90.7%; ≥ Grade 3, 321/528; 60.8%),(单药组:any grade, 77/123; 62.6%; ≥ Grade 3, 42/123; 34.2%)。任何级别不良事件中最常见的是中性粒细胞减少 (联合组: 49.6%; 单药组: 8.9%),疲劳(联合组: 19.5%; 单药组: 13.8%), 以及食欲下降(联合组: 18.2%; 单药组: 10.6%)。4例患者发生了5级不良事件,包括脑膜转移,肺炎,死亡和胃穿孔。其中胃穿孔认为是治疗相关。

             常见不良事件

6个月时,658例患者中有490例(74.5%)中止了雷莫芦单抗治疗,168例(25.5%)仍继续在治疗。12个月时,另外119例患者中止了治疗(累计中止0 ~ 12个月:92.6%),48例(7.3%)仍在治疗(研究结束时)。两组中断治疗的原因比较相似。导致停药最常见的不良反应是贫血(n = 12;15.2%),中性粒细胞计数下降(n = 10;12.7%),发热性中性粒细胞减少(n = 6;7.6%)、高血压(n = 6;7.6%)和脱发(n = 5;6.3%)。五名病人因神经病变中止治疗,所有患者之前都接受过奥沙利铂治疗(5/268;1.9%)。

                雷莫芦单抗中断治疗比例和原因

单药组治疗和联合组治疗的中位生存时间分别为5.7个月(95% CI 4.1-6.8个月)和11.0个月(95% CI 9.8-12.2个月)。根据患者病人是否有腹水进行亚组分析时发现,伴有腹水的患者中位生存期较低。单药治疗组中伴有腹水的中位生存为3.9个月,无腹水的为6.8个月;联合治疗组中伴腹水的中位生存为7.3个月,没有腹水的为15.5个月。

                     生存分析

综上,该日本的真实世界研究表明,雷莫芦单抗(ramucirumab)治疗晚期胃癌的疗效和安全性跟临床研究的一致。

原始出处:

Yucherng Chen, Taeko Katayose, Soshi Nagaoka, et al. A post-marketing observational study of ramucirumab in patients with gastric cancer in Japan. Gastric Cancer. 2021 May 28.  doi: 10.1007/s10120-021-01199-0.  Online ahead of print.

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time=2021-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970139, encodeId=a2939e0139ac, content=厉害。, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210601/0c859446eb874afc9487c484b39a509f/6d087cb94ec948f0ac56f5531151f29d.jpg, createdBy=edca5511040, createdName=北海银滩, createdTime=Tue Jun 01 19:32:32 CST 2021, time=2021-06-01, status=1, ipAttribution=)]
    2021-08-06 skhzy
  4. [GetPortalCommentsPageByObjectIdResponse(id=1912612, encodeId=cdd51912612f0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Thu Aug 05 23:46:03 CST 2021, time=2021-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1712824, encodeId=3f851e12824bf, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, 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time=2021-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970139, encodeId=a2939e0139ac, content=厉害。, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210601/0c859446eb874afc9487c484b39a509f/6d087cb94ec948f0ac56f5531151f29d.jpg, createdBy=edca5511040, createdName=北海银滩, createdTime=Tue Jun 01 19:32:32 CST 2021, time=2021-06-01, status=1, ipAttribution=)]
  5. 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time=2021-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970139, encodeId=a2939e0139ac, content=厉害。, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210601/0c859446eb874afc9487c484b39a509f/6d087cb94ec948f0ac56f5531151f29d.jpg, createdBy=edca5511040, createdName=北海银滩, createdTime=Tue Jun 01 19:32:32 CST 2021, time=2021-06-01, status=1, ipAttribution=)]
    2021-12-06 许安
  6. [GetPortalCommentsPageByObjectIdResponse(id=1912612, encodeId=cdd51912612f0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Thu Aug 05 23:46:03 CST 2021, time=2021-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1712824, encodeId=3f851e12824bf, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, 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  7. 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  8. 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time=2021-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=970139, encodeId=a2939e0139ac, content=厉害。, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210601/0c859446eb874afc9487c484b39a509f/6d087cb94ec948f0ac56f5531151f29d.jpg, createdBy=edca5511040, createdName=北海银滩, createdTime=Tue Jun 01 19:32:32 CST 2021, time=2021-06-01, status=1, ipAttribution=)]
    2021-06-01 北海银滩

    厉害。

    0

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