Oncologist: Sorafenib(索拉非尼)联合Capecitabine(卡培他滨)治疗既往治疗过的转移性结直肠癌患者的疗效和安全性

2021-11-30 yd2015 MedSci原创

研究表明,sorafenib(索拉非尼)联合capecitabine(卡培他滨)治疗既往治疗过的转移性结直肠癌患者有一定临床疗效,毒性明显但是可控。

转移性结直肠癌(mCRC)三线治疗的疗效比较有限。因此,来自美国团队开展了一项II期临床研究,评估sorafenib(sor,索拉非尼)联合capecitabine(Cape,卡培他滨)治疗既往治疗过的转移性结直肠癌患者的疗效和安全性。相关结果发表在Oncologist杂志上。

该研究是单臂的II期临床研究(NCT01471353)。入组患者接受索拉非尼 (200 mg bid,每天)和卡培他滨 (1,000 mg/m 2 bidd1–14)21天为一周期。主要研究终点为PFS,次要研究终点为ORR、总生存期(OS)、DCR、毒性、 3个月时PFS和OS。

研究筛查77例患者,最终纳入42例患者,其中男性33例,女性9例。中位年龄为56.6 (36–78)岁。ECOG 0分有19例患者,1分有19例,2分有3例。IV期患者有42(100%)BRAF野生型有12 (31%) KRAS突变有 21 (50%) KRAS野生型有18 (42.9%) MSI low1 (2.4%)MSS12 (28.6%)。既往贝伐珠单抗治疗有34(81%),既往卡培他滨治疗有17 (40.5%)既往使用西妥昔单抗或帕尼单抗有18(42.9%)

42例患者中,患者接受了平均3.5个周期(范围,1-39个周期)的联合治疗。无患者达到CR,1 (2.4%)例患者PR,22 (52.4%)例患者SD,而14(33.3%)例患者PD。ORR为2.4% (0.01–0.13),DCR为54.8% (0.39–0.70)。

            疗效评估

中位PFS为6.2个月(95% CI, 4.3-7.9),较既往研究的PFS有所延长(3个月;p =0.0004)。本研究队列的中位生存期(OS)为8.8个月(95% CI, 4.3-12.2)。3个月PFS率为83.3% (95% CI 68.2%-91.7%), 6个月PFS为52.4% (95% CI 36.4%-66.1%), 3个月OS率为83.3% (95% CI 68.2%-91.7%), 6个月OS率为64.3% (95% CI 47.9%-76.7%)。

                   PFS和OS

手足综合征是最常见的不良事件,发生在36(85.7%)患者中,≥3级不良反应有16(38.1%)1名患者(2.4%)出现4级脓毒症,1名患者(2.4%)在治疗期间死亡。

            AEs

综上,研究表明,sorafenib(索拉非尼)联合capecitabine(卡培他滨)治疗既往治疗过的转移性结直肠癌患者有一定临床疗效,毒性明显但是可控。

原始出处:

George TJ, Ivey AM, Ali A, Lee JH, Wang Y, Daily KC, Ramnaraign BH, Tan SA, Terracina KP, Read TE, Dang LH, Iqbal A. Activity of Sorafenib Plus Capecitabine in Previously Treated Metastatic Colorectal Cancer. Oncologist. 2021 May;26(5):362-e724. doi: 10.1002/onco.13689. Epub 2021 Feb 22. PMID: 33512054; PMCID: PMC8100547.

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    2022-09-22 minlingfeng
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    2022-11-02 feather89
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createdName=crystal0564, createdTime=Thu Dec 02 11:35:22 CST 2021, time=2021-12-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455190, encodeId=f0aa145519016, content=<a href='/topic/show?id=bebe8032fc' target=_blank style='color:#2F92EE;'>#GIST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8032, encryptionId=bebe8032fc, topicName=GIST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e445632366, createdName=july_977, createdTime=Thu Dec 02 11:35:22 CST 2021, time=2021-12-02, status=1, ipAttribution=)]
  5. 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createdName=crystal0564, createdTime=Thu Dec 02 11:35:22 CST 2021, time=2021-12-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1455190, encodeId=f0aa145519016, content=<a href='/topic/show?id=bebe8032fc' target=_blank style='color:#2F92EE;'>#GIST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8032, encryptionId=bebe8032fc, topicName=GIST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6e445632366, createdName=july_977, createdTime=Thu Dec 02 11:35:22 CST 2021, time=2021-12-02, status=1, ipAttribution=)]
    2022-11-08 smlt2008
  6. [GetPortalCommentsPageByObjectIdResponse(id=1866390, encodeId=1b981866390de, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Thu Sep 22 11:35:22 CST 2022, time=2022-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1738607, encodeId=febc1e3860762, content=<a href='/topic/show?id=a9dd4e63c4' target=_blank style='color:#2F92EE;'>#CIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4763, encryptionId=a9dd4e63c4, topicName=CIT)], attachment=null, authenticateStatus=null, createdAvatar=null, 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  7. 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    2021-12-02 july_977

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