LANCET：吉西他滨+卡培他滨vs.吉西他滨单一给药在胰腺癌切除术后的疗效

2017-01-30 MedSci MedSci原创

ESPAC-3试验显示，胰腺癌切除的术后患者，辅助性吉西他滨与佐剂5-氟尿嘧啶/亚叶酸一样具有相似的生存效果，但具有更小的毒性的标准治疗。另一些临床试验显示，在晚期或转移性胰腺癌中，与单独的吉西他滨相比，吉西他滨和卡培他滨联合具有更好的存活和肿瘤反应。近期，一项发表在权威杂志LANCET上的研究了吉西他滨和卡培他滨与吉西他滨单药治疗在切除胰腺癌的患者中的疗效和安全性。研究者们在英格兰、苏格兰、威尔

ESPAC-3试验显示，胰腺癌切除的术后患者，辅助性吉西他滨与佐剂5-氟尿嘧啶/亚叶酸一样具有相似的生存效果，但具有更小的毒性的标准治疗。另一些临床试验显示，在晚期或转移性胰腺癌中，与单独的吉西他滨相比，吉西他滨和卡培他滨联合具有更好的存活和肿瘤反应。

近期，一项发表在权威杂志LANCET上的研究了吉西他滨和卡培他滨与吉西他滨单药治疗在切除胰腺癌的患者中的疗效和安全性。

研究者们在英格兰、苏格兰、威尔士、德国、法国和瑞典的92家医院进行了3期、两组、开放标签、多中心的随机临床试验。入组患者年龄18岁及以上，并已完成胰腺导管腺癌（R0或R1切除）的完全宏观切除术。

手术的12周内随机分配患者（1：1）以接受6个周期的1000mg/m2吉西他滨单独给药，每周1次进行3次，每4周为一个周期或1660mg/m2口服卡培他滨21天，然后7天休息（一个周期）。

主要终点是总体存活，测量为从随机化开始到任意原因引起的死亡，并在意向治疗群体中评估。在接受试验治疗的所有患者中分析毒性。该试验注册于EudraCT，编号2007-004299-38和ISRCTN，编号ISRCTN96397434。

研究结果显示：在招募的732例患者中，730例包括在最终分析中。其中366名随机分配为吉西他滨，364名为吉西他滨加卡培他滨。吉西他滨加卡培他滨组的中位总生存期为28.0个月（95％CI 23.5-31.5），而吉西他滨组为25.5个月（22.7-27.9）（危险比率0.82 [95％CI 0.68-0.98]，p=0.032）。吉西他滨加卡培他滨组359名患者中有226名发生3-4级不良事件，而吉西他滨组366名患者中有196名发生3-4级不良事件。

此项研究得出新的启示：吉西他滨和卡培他滨的佐剂组合应当是切除胰腺导管腺癌后的新治疗标准。

原始出处：
Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017 Jan 24. pii: S0140-6736(16)32409-6. doi: 10.1016/S0140-6736(16)32409-6.

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2017-12-22 howi

#Lancet#

31 0
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2017-03-01 doctorzheng

#切除术#

29 0
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2017-02-04 老段

学习一下，涨知识！

55 0
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2017-02-03 李东泽

很好，不错，以后会多学习

55 0
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2017-02-03 ylzr123

好文，值得点赞，值得拥有，值得收藏！

54 0
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2017-02-03 圣艮山

学习了不少

43 0
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createdTime=Fri Feb 03 21:57:17 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173965, encodeId=4abf1e396512, content=好文，值得点赞，值得拥有，值得收藏！, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7s7ZCKOmmbBTD6nE7gcd5OZpvyGEzkxBP3S275k5ZJVrsPkotZhBglRHM9rKvcj1OgkssqhcnoPw8zIaMZTF8c/0, createdBy=4c441942088, createdName=ylzr123, createdTime=Fri Feb 03 11:36:15 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173961, encodeId=ce4a1e396148, content=学习了不少, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36493, encryptionId=a82f36493c4, topicName=卡培他滨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c8c241, createdName=w363522449, createdTime=Wed Feb 01 04:10:00 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173502, encodeId=f3d01e35020a, content=文章很好，值得一读, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Tue Jan 31 21:33:28 CST 2017, time=2017-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173436, encodeId=d1d81e3436c8, content=学习了很厉害, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Tue Jan 31 11:13:56 CST 2017, time=2017-01-31, status=1, ipAttribution=)]
2017-02-02 卡圣

长见识了

39 0
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createdTime=Fri Feb 03 21:57:17 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173965, encodeId=4abf1e396512, content=好文，值得点赞，值得拥有，值得收藏！, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7s7ZCKOmmbBTD6nE7gcd5OZpvyGEzkxBP3S275k5ZJVrsPkotZhBglRHM9rKvcj1OgkssqhcnoPw8zIaMZTF8c/0, createdBy=4c441942088, createdName=ylzr123, createdTime=Fri Feb 03 11:36:15 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173961, encodeId=ce4a1e396148, content=学习了不少, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K4BGdu4COj6QWFqgMd3xnWDdgLZKUGI32veZvO2qFAQvpYr1eMbUOTqMvlZWc3MsugtFMHzxDwial/0, createdBy=88731939304, createdName=圣艮山, createdTime=Fri Feb 03 11:34:12 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173703, encodeId=20df1e3703d4, content=长见识了, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Thu Feb 02 04:50:12 CST 2017, time=2017-02-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1293500, encodeId=b615129350006, content=<a href='/topic/show?id=a82f36493c4' target=_blank style='color:#2F92EE;'>#卡培他滨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36493, encryptionId=a82f36493c4, topicName=卡培他滨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c8c241, createdName=w363522449, createdTime=Wed Feb 01 04:10:00 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173502, encodeId=f3d01e35020a, content=文章很好，值得一读, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Tue Jan 31 21:33:28 CST 2017, time=2017-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173436, encodeId=d1d81e3436c8, content=学习了很厉害, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Tue Jan 31 11:13:56 CST 2017, time=2017-01-31, status=1, ipAttribution=)]
2017-02-01 w363522449

#卡培他滨#

23 0
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createdTime=Fri Feb 03 21:57:17 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173965, encodeId=4abf1e396512, content=好文，值得点赞，值得拥有，值得收藏！, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7s7ZCKOmmbBTD6nE7gcd5OZpvyGEzkxBP3S275k5ZJVrsPkotZhBglRHM9rKvcj1OgkssqhcnoPw8zIaMZTF8c/0, createdBy=4c441942088, createdName=ylzr123, createdTime=Fri Feb 03 11:36:15 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173961, encodeId=ce4a1e396148, content=学习了不少, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K4BGdu4COj6QWFqgMd3xnWDdgLZKUGI32veZvO2qFAQvpYr1eMbUOTqMvlZWc3MsugtFMHzxDwial/0, createdBy=88731939304, createdName=圣艮山, createdTime=Fri Feb 03 11:34:12 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173703, encodeId=20df1e3703d4, content=长见识了, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Thu Feb 02 04:50:12 CST 2017, time=2017-02-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1293500, encodeId=b615129350006, content=<a href='/topic/show?id=a82f36493c4' target=_blank style='color:#2F92EE;'>#卡培他滨#</a>, beContent=null, 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content=学习了很厉害, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Tue Jan 31 11:13:56 CST 2017, time=2017-01-31, status=1, ipAttribution=)]
2017-01-31 1e10c84am36(暂无匿称)

文章很好，值得一读

16 0
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createdTime=Fri Feb 03 21:57:17 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173965, encodeId=4abf1e396512, content=好文，值得点赞，值得拥有，值得收藏！, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7s7ZCKOmmbBTD6nE7gcd5OZpvyGEzkxBP3S275k5ZJVrsPkotZhBglRHM9rKvcj1OgkssqhcnoPw8zIaMZTF8c/0, createdBy=4c441942088, createdName=ylzr123, createdTime=Fri Feb 03 11:36:15 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173961, encodeId=ce4a1e396148, content=学习了不少, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K4BGdu4COj6QWFqgMd3xnWDdgLZKUGI32veZvO2qFAQvpYr1eMbUOTqMvlZWc3MsugtFMHzxDwial/0, createdBy=88731939304, createdName=圣艮山, createdTime=Fri Feb 03 11:34:12 CST 2017, time=2017-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173703, encodeId=20df1e3703d4, content=长见识了, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Thu Feb 02 04:50:12 CST 2017, time=2017-02-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1293500, encodeId=b615129350006, content=<a href='/topic/show?id=a82f36493c4' target=_blank style='color:#2F92EE;'>#卡培他滨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36493, encryptionId=a82f36493c4, topicName=卡培他滨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c8c241, createdName=w363522449, createdTime=Wed Feb 01 04:10:00 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173502, encodeId=f3d01e35020a, content=文章很好，值得一读, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Tue Jan 31 21:33:28 CST 2017, time=2017-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173436, encodeId=d1d81e3436c8, content=学习了很厉害, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Tue Jan 31 11:13:56 CST 2017, time=2017-01-31, status=1, ipAttribution=)]
2017-01-31 天涯183

学习了很厉害

21 0