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Lancer Oncol：司美替尼对复发的卵巢低分化鳞癌有效

2013-01-07 Lancer Oncol dxy echo1166

司美替尼鳞状细胞癌低分化
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　　卵巢低级别鳞状细胞癌对化疗反应不佳，但是MAPK旁路突变能靶向控制肿瘤生长。因此本文的研究者旨在评估在低级别卵巢鳞状细胞癌患者中应用MEK1/2抑制剂——司美替尼的安全性和治疗作用。来自美国St Joseph's医院和医学中心John Farley等将其相关研究结果发表在Lancet Oncol 12月最新的在线期刊上。 　　本研究未开放式标签、

　　卵巢低级别鳞状细胞癌对化疗反应不佳，但是MAPK旁路突变能靶向控制肿瘤生长。因此本文的研究者旨在评估在低级别卵巢鳞状细胞癌患者中应用MEK1/2抑制剂——司美替尼的安全性和治疗作用。来自美国St Joseph's医院和医学中心John Farley等将其相关研究结果发表在Lancet Oncol 12月最新的在线期刊上。

　　本研究未开放式标签、2期单组临床研究，研究的入组标准为：年龄在18岁或以上的女性、存在卵巢及腹膜低级别鳞状细胞癌复发，这些患者每日两次口服50mg司美替尼直至其疾病出现进展。研究的主要终点为在所有接受治疗的患者中，对治疗出现客观应答的患者所占的比例（符合RECIST 1.1版标准）。对研究的结果采用意向治疗分析法进行分析。本研究在ClinicalTrials.gov注册。

　　在2007年12月17日至2009年11月23日期间，共有52名受试者被纳入研究。所有的患者都被纳入结果分析。在这些患者中，8人对治疗出现客观应答，其中一人出现完全应答，另七人为部分应答。34名患者疾病稳定。在研究过程中没有出现与治疗相关的死亡事件。4级毒性反应包括：心脏毒性（1人）、疼痛（1人）和肺部病变（1人）。至少出现在1名患者中的3级毒性反应包括：胃肠道毒性反应（13人）、皮肤病变（9人）、代谢病变（7人）、疲劳（6人）、贫血（4人）、疼痛（4人）和心脏病变（2人）。

　　研究结果显示，受试者能很好的耐受司美替尼治疗，并且药物治疗对卵巢及腹膜低级别鳞状细胞癌复发的女性患者有效。本研究的结果提示需要在这类患者中进一步针对MAPK旁路抑制剂进行研究。




Background

Low-grade serous carcinoma of the ovary is chemoresistant but mutations in the MAPK pathway could be targeted to control tumour growth. We therefore assessed the safety and activity of selumetinib, an inhibitor of MEK1/2, for patients with this cancer.

Methods

In this open-label, single-arm phase 2 study, women (aged ≥18 years) with recurrent low-grade serous ovarian or peritoneal carcinoma were given selumetinib (50 mg twice daily, orally) until progression. The primary endpoint was the proportion of patients who had an objective tumour response according to RECIST version 1.1, assessed for all the treated patients. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00551070.

Findings

52 patients were enrolled between Dec 17, 2007, and Nov 23, 2009. All were eligible for analyses. Eight (15%) patients had an objective response to treatment—one patient had a complete response and seven had partial responses. 34 (65%) patients had stable disease. There were no treatment-related deaths. Grade 4 toxicities were cardiac (one), pain (one), and pulmonary events (one). Grade 3 toxicities that occurred in more than one patient were gastrointestinal (13), dermatological (nine), metabolic (seven), fatigue (six), anaemia (four), pain (four), constitutional (three), and cardiac events (two).

Interpretation

Selumetinib is well tolerated, and is active in the treatment of recurrent low-grade serous carcinoma of the ovary or peritoneum. The findings suggest that inhibitors of the MAPK pathway warrant further investigation in these patients.

Funding

National Cancer Institute.

    

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    2013-05-30 124987c6m36暂无昵称

    #低分化#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1923419, encodeId=13481923419e5, content=<a href='/topic/show?id=fa0d2615677' target=_blank style='color:#2F92EE;'>#低分化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26156, encryptionId=fa0d2615677, topicName=低分化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=85152500072, createdName=124987c6m36暂无昵称, createdTime=Thu May 30 06:26:00 CST 2013, time=2013-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1864404, encodeId=79281864404b0, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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 19 08:26:00 CST 2013, time=2013-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1484595, encodeId=26911484595da, content=<a href='/topic/show?id=3502102944e7' target=_blank style='color:#2F92EE;'>#鳞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102944, encryptionId=3502102944e7, topicName=鳞癌)], attachment=null, authenticateStatus=null, createdAvatar=Bioon/avatar/20171006/a73877485ccdf6add82293e671bebe21.jpg, createdBy=745a7977375, createdName=1696533704_45270456, createdTime=Wed Jan 09 01:26:00 CST 2013, time=2013-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568062, encodeId=8b761568062e6, content=<a href='/topic/show?id=b24138e29a0' target=_blank style='color:#2F92EE;'>#司美替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38729, encryptionId=b24138e29a0, topicName=司美替尼)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=417515318083, createdName=lqvr, createdTime=Wed Jan 09 01:26:00 CST 2013, time=2013-01-09, status=1, ipAttribution=)]
    2013-09-19 minlingfeng

    #Oncol#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1923419, encodeId=13481923419e5, content=<a href='/topic/show?id=fa0d2615677' target=_blank style='color:#2F92EE;'>#低分化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26156, encryptionId=fa0d2615677, topicName=低分化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=85152500072, createdName=124987c6m36暂无昵称, createdTime=Thu May 30 06:26:00 CST 2013, time=2013-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1864404, encodeId=79281864404b0, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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 19 08:26:00 CST 2013, time=2013-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1484595, encodeId=26911484595da, content=<a href='/topic/show?id=3502102944e7' target=_blank style='color:#2F92EE;'>#鳞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102944, encryptionId=3502102944e7, topicName=鳞癌)], attachment=null, authenticateStatus=null, createdAvatar=Bioon/avatar/20171006/a73877485ccdf6add82293e671bebe21.jpg, createdBy=745a7977375, createdName=1696533704_45270456, createdTime=Wed Jan 09 01:26:00 CST 2013, time=2013-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568062, encodeId=8b761568062e6, content=<a href='/topic/show?id=b24138e29a0' target=_blank style='color:#2F92EE;'>#司美替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38729, encryptionId=b24138e29a0, topicName=司美替尼)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=417515318083, createdName=lqvr, createdTime=Wed Jan 09 01:26:00 CST 2013, time=2013-01-09, status=1, ipAttribution=)]
    2013-01-09 1696533704_45270456

    #鳞癌#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1923419, encodeId=13481923419e5, content=<a href='/topic/show?id=fa0d2615677' target=_blank style='color:#2F92EE;'>#低分化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26156, encryptionId=fa0d2615677, topicName=低分化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=85152500072, createdName=124987c6m36暂无昵称, createdTime=Thu May 30 06:26:00 CST 2013, time=2013-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1864404, encodeId=79281864404b0, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, 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 19 08:26:00 CST 2013, time=2013-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1484595, encodeId=26911484595da, content=<a href='/topic/show?id=3502102944e7' target=_blank style='color:#2F92EE;'>#鳞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102944, encryptionId=3502102944e7, topicName=鳞癌)], attachment=null, authenticateStatus=null, createdAvatar=Bioon/avatar/20171006/a73877485ccdf6add82293e671bebe21.jpg, createdBy=745a7977375, createdName=1696533704_45270456, createdTime=Wed Jan 09 01:26:00 CST 2013, time=2013-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1568062, encodeId=8b761568062e6, content=<a href='/topic/show?id=b24138e29a0' target=_blank style='color:#2F92EE;'>#司美替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=38729, encryptionId=b24138e29a0, topicName=司美替尼)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=417515318083, createdName=lqvr, createdTime=Wed Jan 09 01:26:00 CST 2013, time=2013-01-09, status=1, ipAttribution=)]
    2013-01-09 lqvr

    #司美替尼#

    0