Transl Lung Cancer Res: 那武利尤单抗联合重组人内皮抑素治疗既往经治晚期非小细胞肺癌的安全性和有效性

2022-03-16 网络 网络

这项研究是首次评估nivolumab加重组人内皮抑素在既往经治晚期NSCLC患者中的作用。鉴于其良好的疗效和安全性,该组合为有前途的治疗方案。

免疫检查点抑制剂(ICIs)联合抗血管生成药物在既往治疗过的晚期非小细胞肺癌(NSCLC)患者中的有效性证据仍然不足。近期,来自中山大学附属第五医院的团队开展了相关研究,评估nivolumab(那武利尤单抗)联合重组人内皮抑素在既往经治晚期非小细胞肺癌(NSCLC)的安全性和有效性。相关结果发表在Translational Lung Cancer Research杂志上。

研究纳入EGFR/ALK阴性的晚期NSCLC患者,既往治疗后进展。符合条件的患者每2周接受nivolumab (3mg /kg,静脉滴注,第1天),每4周接受重组人内皮抑素(210 mg,持续静脉滴注168 h),直到疾病进展或停止治疗。主要终点为客观缓解率(ORR)。次要终点包括疾病控制率(DCR)、缓解期(DOR)、临床受益缓解率(CBR)、无进展生存期(PFS)、总生存期(OS)和安全性。

研究纳入34例患者,中位年龄为60岁(范围37 72岁),26.5%为ECOG PS评分2分,50.0%为目前或以前吸烟者。腺癌22例(64.7%),鳞状细胞癌8例(23.5%),淋巴上皮瘤样癌4例。

34例患者接受中位4个周期的治疗。总共有14例患者获得了确认的部分缓解(PR), ORR为41.2% [14/34;95%可信区间(CI): 23.7 58.6%], DCR为64.7% (22/34;95% CI: 47.8 81.6%), CBR为44.1% (95% CI: 26.5 61.7%), DOR为6.9 (95% CI: 4.4 9.4)月。

中位随访时间为12.2个月(范围为2.3-18.1个月)。中位PFS (mPFS)为6.8个月(95% CI: 1.1-12.1),中位OS (mOS)为17.1个月(95% CI: 6.6-27.6), 12个月生存率为64.4% (95% CI: 46.2-82.6%)。

与ECOG PS=2患者相比,ECOG PS= 0-1患者的mPFS(12.5 vs 1.7个月;p<0.001)和mOS(17.1个月比3.4个月;p<0.001)更长。同样,与其他患者相比,≦两个转移器官的患者获得了更长的mPFS(9.4个月vs. 3.3个月;P=0.027)和mOS (17.1 vs. 5.3个月;P = 0.006)。无脑转移的患者mPFS(7.5个月vs. 1.8个月;P=0.037)和mOS (17.1 vs. 5.3个月;P=0.029)明显优于脑转移患者。然而,从未接受过抗血管生成治疗的患者mPFS更好(12.5 vs 2.8个月;P=0.021),但mOS相似[17.1个月vs.未达到(NR);P = 0.112)。

18例(18/34,52.9%)患者发生至少一次治疗相关不良事件(TRAE),其中4例(4/34,11.8%)发生3级TRAE。

综上,这项研究是首次评估nivolumab加重组人内皮抑素在既往经治晚期NSCLC患者中的作用。鉴于其良好的疗效和安全性,该组合为有前途的治疗方案。

 

原始出处:

Lv W, Pei X, Zhao W, Cong Y, Wei Y, Li T, Zhang H, Lin Z, Saito Y, Kim JJ, Liang Z, Zhong B, Wang Z. Safety and efficacy of nivolumab plus recombinant human endostatin in previously treated advanced non-small-cell lung cancer. Transl Lung Cancer Res. 2022 Feb;11(2):201-212. doi: 10.21037/tlcr-22-49. PMID: 35280309; PMCID: PMC8902090.

 

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    2023-02-12 docwu2019
  5. [GetPortalCommentsPageByObjectIdResponse(id=2060097, encodeId=7cb1206009e1b, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Sat May 21 02:41:07 CST 2022, time=2022-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2066699, encodeId=ff4a2066699a0, content=<a href='/topic/show?id=1d3d45e090e' target=_blank style='color:#2F92EE;'>#安全性和有效性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45709, encryptionId=1d3d45e090e, topicName=安全性和有效性)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/E33DC517C2EC449E463E3D01D81745BA/100, createdBy=75e12500157, createdName=ms1756883563247400, createdTime=Mon Feb 06 13:41:07 CST 2023, time=2023-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2067620, encodeId=996c206e62097, content=<a href='/topic/show?id=d0841e75535' target=_blank style='color:#2F92EE;'>#Transl#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17755, encryptionId=d0841e75535, topicName=Transl)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/101173734/363C99735735B7F4CB11D5F78F580525/100, createdBy=aab22500211, createdName=ms3025846204744509, createdTime=Tue Jan 24 02:41:07 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657619, encodeId=36ef165e6192f, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sun Feb 12 19:41:07 CST 2023, time=2023-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1203416, encodeId=ab731203416be, content=<a href='/topic/show?id=23e3454e353' target=_blank style='color:#2F92EE;'>#学习#</a>学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45473, encryptionId=23e3454e353, topicName=学习)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c8e15563207, createdName=最黄的大芒果, createdTime=Thu Mar 17 12:22:37 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1203343, encodeId=3c7912033438c, content=好文章,值得一读。, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Thu Mar 17 07:02:14 CST 2022, time=2022-03-17, status=1, ipAttribution=)]
    2022-03-17 最黄的大芒果

    #学习#学习

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2060097, encodeId=7cb1206009e1b, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Sat May 21 02:41:07 CST 2022, time=2022-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2066699, encodeId=ff4a2066699a0, content=<a href='/topic/show?id=1d3d45e090e' target=_blank style='color:#2F92EE;'>#安全性和有效性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45709, encryptionId=1d3d45e090e, topicName=安全性和有效性)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/E33DC517C2EC449E463E3D01D81745BA/100, createdBy=75e12500157, createdName=ms1756883563247400, createdTime=Mon Feb 06 13:41:07 CST 2023, time=2023-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2067620, encodeId=996c206e62097, content=<a href='/topic/show?id=d0841e75535' target=_blank style='color:#2F92EE;'>#Transl#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17755, encryptionId=d0841e75535, topicName=Transl)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/101173734/363C99735735B7F4CB11D5F78F580525/100, createdBy=aab22500211, createdName=ms3025846204744509, createdTime=Tue Jan 24 02:41:07 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1657619, encodeId=36ef165e6192f, content=<a href='/topic/show?id=3ca31e71903' target=_blank style='color:#2F92EE;'>#TRA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17719, encryptionId=3ca31e71903, topicName=TRA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sun Feb 12 19:41:07 CST 2023, time=2023-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1203416, encodeId=ab731203416be, content=<a href='/topic/show?id=23e3454e353' target=_blank style='color:#2F92EE;'>#学习#</a>学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45473, encryptionId=23e3454e353, topicName=学习)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c8e15563207, createdName=最黄的大芒果, createdTime=Thu Mar 17 12:22:37 CST 2022, time=2022-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1203343, encodeId=3c7912033438c, content=好文章,值得一读。, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Thu Mar 17 07:02:14 CST 2022, time=2022-03-17, status=1, ipAttribution=)]
    2022-03-17 yangchou

    好文章,值得一读。

    0

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