Lancet Oncology:Selumetinib+多西紫杉醇治疗NSCLC或更有效

2012-12-03 Lancet Oncology Lancet Oncology

一项随机、多中心、安慰剂对照的临床Ⅱ期研究表明,在既往接受过治疗的KRAS突变的NSCLC患者中,Selumetinib加多西紫杉醇的有效性看好,尽管发生不良事件的次数多于单纯多西紫杉醇组。该论文于2012年11月28日在线发表于《柳叶刀?肿瘤学》〔Lancet Oncology. 2012 Nov 28; 10.1016/S1470-2045(12)70489-8〕。针对KRAS突变的非小细胞癌

一项随机、多中心、安慰剂对照的临床Ⅱ期研究表明,在既往接受过治疗的KRAS突变的NSCLC患者中,Selumetinib加多西紫杉醇的有效性看好,尽管发生不良事件的次数多于单纯多西紫杉醇组。该论文于2012年11月28日在线发表于《柳叶刀•肿瘤学》〔Lancet Oncology. 2012 Nov 28; 10.1016/S1470-2045(12)70489-8〕。

针对KRAS突变的非小细胞癌(NSCLC)还没有靶向治疗方法。Selumetinib是一种MEK1/MEK2抑制剂,是KRAS的下游,有临床前证据表明Selumetinib在治疗KRAS突变的癌症时与多西紫杉醇联用具有增效活性。该研究对既往治疗过的晚期KRAS突变的NSCLC患者进行了一项前瞻性、随机、Ⅱ期临床试验以评价Selumetinib加多西紫杉醇的疗效。

患者纳入标准:年龄大于18岁;经组织学或细胞学确诊的IIIB—IV期KRAS突变的NSCLC患者;一线治疗失败的晚期NSCLC患者;WHO体力状态为0—1;既往未接受过MEK抑制剂或多西紫杉醇治疗;骨髓造血功能、肾功和肝功完全。将患者按照1:1的比例随机分配到口服Selumetinib(第一天75 mg/m2,21天为一周期)组或安慰剂组;所有的患者接受多西紫杉醇静脉注射(第一天75 mg/m2,21天为一周期)。通过互动语音电话系统进行随机化分组,治疗分配情况对研究人员、患者、数据分析人员和试验资助者都设盲。主要终点是对所有确诊为KRAS突变患者的总体生存时间。

从2009年4月20日到2010年6月30日,研究人员随机分配44名患者接受Selumetinib加多西紫杉醇治疗(Selumetinib组),43名患者接受安慰剂加多西紫杉醇治疗(安慰剂组)。这些患者中,Selumetinib组和安慰剂组中分别有1人和3人由于肿瘤经确诊不是KRAS突变阳性而被排除。

结果显示,Selumetinib组和对照组的中位总体生存时间分别为9.4个月和5.2个月(死亡危险比为0.8)。Selumetinib组和对照组的中位无进展生存期分别为5.3个月和2.1个月(病情进展的危险比为0.58)。Selumetinib组和对照组分别有16人(37%)或0人发生目标反应(p<0•0001)。Selumetinib组和对照组分别有82%和67%的患者发生3级或以上的不良事件。最常见的3-4级不良事件为中性粒细胞减少、发热性中性粒细胞减少、呼吸困难和无力。



Background
No targeted therapies are available for KRAS-mutant non-small-cell lung cancer (NSCLC). Selumetinib is an inhibitor of MEK1/MEK2, downstream of KRAS, with preclinical evidence of synergistic activity with docetaxel in KRAS-mutant cancers. We did a prospective, randomised, phase 2 trial to assess selumetinib plus docetaxel in previously treated patients with advanced KRAS-mutant NSCLC.
Methods
Eligible patients were older than 18 years of age; had histologically or cytologically confirmed stage IIIB—IV KRAS-mutant NSCLC; had failed first-line therapy for advanced NSCLC; had WHO performance status of 0—1; had not received previous therapy with either a MEK inhibitor or docetaxel; and had adequate bone marrow, renal, and liver function. Patients were randomly assigned (in a 1:1 ratio) to either oral selumetinib (75 mg twice daily in a 21 day cycle) or placebo; all patients received intravenous docetaxel (75 mg/m2 on day 1 of a 21 day cycle). Randomisation was done with an interactive voice response system and investigators, patients, data analysts, and the trial sponsor were masked to treatment assignment. The primary endpoint was overall survival, analysed for all patients with confirmed KRAS mutations. This study is registered with ClinicalTrials.gov, number NCT00890825.
Findings
Between April 20, 2009, and June 30, 2010, we randomly assigned 44 patients to receive selumetinib and docetaxel (selumetinib group) and 43 to receive placebo and docetaxel (placebo group). Of these, one patient in the selumetinib group and three in the placebo group were excluded from efficacy analyses because their tumours were not confirmed to be KRAS-mutation positive. Median overall survival was 9·4 months (6·8—13·6) in the selumetinib group and 5·2 months (95% CI 3·8—non-calculable) in the placebo group (hazard ratio [HR] for death 0·80, 80% CI 0·56—1·14; one-sided p=0·21). Median progression-free survival was 5·3 months (4·6—6·4) in the selumetinib group and 2·1 months (95% CI 1·4—3·7) in the placebo group (HR for progression 0·58, 80% CI 0·42—0·79; one-sided p=0·014). 16 (37%) patients in the selumetinib group and none in the placebo group had an objective response (p<0·0001). Adverse events of grade 3 or higher occurred in 36 (82%) patients in the selumetinib group and 28 (67%) patients in the placebo group. The most common grade 3—4 adverse events were neutropenia (29 [67%] of 43 patients in the selumetinib group vs 23 [55%] of 42 patients in the placebo group), febrile neutropenia (eight [18%] of 44 patients in the selumetinib group vs none in the placebo group), dyspnoea (one [2%] of 44 patients in the selumetinib group vs five [12%] of 42 in the placebo group), and asthenia (four [9%] of 44 patients in the selumetinib group vs none in the placebo group).
Interpretation
Selumetinib plus docetaxel has promising efficacy, albeit with a higher number of adverse events than with docetaxel alone, in previously treated advanced KRAS-mutant NSCLC. These findings warrant further clinical investigation of selumetinib plus docetaxel in KRAS-mutant NSCLC.
Funding
AstraZeneca.

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    2021-07-25 小小医者

    #selumetinib#从2012年想用于#NSCLC#,但最终到2019年被#FDA#批准上市,但是适应症变了,用于1型#神经纤维瘤#!这也算是华丽转身吧

    0

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    2013-05-01 minlingfeng
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    2013-01-10 howi
  4. [GetPortalCommentsPageByObjectIdResponse(id=1002560, encodeId=0af210025609b, content=<a href='/topic/show?id=a3fc16121f5' target=_blank style='color:#2F92EE;'>#selumetinib#</a>从2012年想用于<a href='/topic/show?id=2493130e1a1' target=_blank style='color:#2F92EE;'>#NSCLC#</a>,但最终到2019年被<a href='/topic/show?id=f336e29134' target=_blank style='color:#2F92EE;'>#FDA#</a>批准上市,但是适应症变了,用于1型<a href='/topic/show?id=5deae44758a' target=_blank style='color:#2F92EE;'>#神经纤维瘤#</a>!这也算是华丽转身吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=156, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16121, encryptionId=a3fc16121f5, topicName=selumetinib), TopicDto(id=13071, encryptionId=2493130e1a1, topicName=NSCLC), TopicDto(id=7291, encryptionId=f336e29134, topicName=FDA), TopicDto(id=74475, encryptionId=5deae44758a, topicName=神经纤维瘤)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=小小医者, createdTime=Sun Jul 25 20:13:17 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1864397, encodeId=e429186439e0d, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Wed May 01 12:19:00 CST 2013, time=2013-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827485, encodeId=75cf182e48582, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Jan 10 13:19:00 CST 2013, time=2013-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1674331, encodeId=537316e4331e0, content=<a href='/topic/show?id=e8aa13359b1' target=_blank style='color:#2F92EE;'>#Oncology#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13359, encryptionId=e8aa13359b1, topicName=Oncology)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7226973259, createdName=circumcision, createdTime=Mon Aug 19 23:19:00 CST 2013, time=2013-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1895647, encodeId=6bff189564e2a, content=<a href='/topic/show?id=4a391158248' target=_blank style='color:#2F92EE;'>#MET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11582, encryptionId=4a391158248, topicName=MET)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=18fc139, createdName=一闲, createdTime=Wed Jan 16 04:19:00 CST 2013, time=2013-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587278, encodeId=c7fc158e27881, content=<a href='/topic/show?id=1bdc43456b3' target=_blank style='color:#2F92EE;'>#多西紫杉醇#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43456, encryptionId=1bdc43456b3, topicName=多西紫杉醇)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2f2717457850, createdName=zhaozhouchifen, createdTime=Wed Dec 05 02:19:00 CST 2012, time=2012-12-05, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1002560, encodeId=0af210025609b, content=<a href='/topic/show?id=a3fc16121f5' target=_blank style='color:#2F92EE;'>#selumetinib#</a>从2012年想用于<a href='/topic/show?id=2493130e1a1' target=_blank style='color:#2F92EE;'>#NSCLC#</a>,但最终到2019年被<a href='/topic/show?id=f336e29134' target=_blank style='color:#2F92EE;'>#FDA#</a>批准上市,但是适应症变了,用于1型<a href='/topic/show?id=5deae44758a' target=_blank style='color:#2F92EE;'>#神经纤维瘤#</a>!这也算是华丽转身吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=156, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16121, encryptionId=a3fc16121f5, topicName=selumetinib), TopicDto(id=13071, encryptionId=2493130e1a1, topicName=NSCLC), TopicDto(id=7291, encryptionId=f336e29134, topicName=FDA), TopicDto(id=74475, encryptionId=5deae44758a, topicName=神经纤维瘤)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=小小医者, createdTime=Sun Jul 25 20:13:17 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1864397, encodeId=e429186439e0d, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Wed May 01 12:19:00 CST 2013, time=2013-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1827485, encodeId=75cf182e48582, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Jan 10 13:19:00 CST 2013, time=2013-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1674331, encodeId=537316e4331e0, content=<a href='/topic/show?id=e8aa13359b1' target=_blank style='color:#2F92EE;'>#Oncology#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13359, encryptionId=e8aa13359b1, topicName=Oncology)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cb7226973259, createdName=circumcision, createdTime=Mon Aug 19 23:19:00 CST 2013, time=2013-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1895647, encodeId=6bff189564e2a, content=<a href='/topic/show?id=4a391158248' target=_blank style='color:#2F92EE;'>#MET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11582, encryptionId=4a391158248, topicName=MET)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=18fc139, createdName=一闲, createdTime=Wed Jan 16 04:19:00 CST 2013, time=2013-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587278, encodeId=c7fc158e27881, content=<a href='/topic/show?id=1bdc43456b3' target=_blank style='color:#2F92EE;'>#多西紫杉醇#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43456, encryptionId=1bdc43456b3, topicName=多西紫杉醇)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2f2717457850, createdName=zhaozhouchifen, createdTime=Wed Dec 05 02:19:00 CST 2012, time=2012-12-05, status=1, ipAttribution=)]
    2013-01-16 一闲
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