阿斯利康的T790M牛逼新药AZD9291的1期临床结果出来了

http://www.inspire.com/groups/lu ... one-on-trial-t790m/
My husband was treated with Tarceva ( erlotinib ) an EGFR inhibitor drug following diagnosed with Advanced stage Iv NSC Lung cancer for nearly 15 months after non responding to several courses of double agents chemotherapy. Unfortunately he developed resistant mutation and tarceva was no longer effective resulting in tumour progression and several metastatic lymph nodes enlargement . He was offered to participate in Phase I trial of AZD9291 drug developed by Astra Zenica. He is one of new participant on very dose AZD9291 ( 160 mg ) daily for the past 7-8 weeks his recent CT scan on 21/10/2013 has been promising. He had intractable diarrhoea & abdominal cramps associated with extreme tiredness & some weight loss with such high dose. He is now taking reduced dose 80 mg daily since 28/10/13 feel much better although still suffers from loose motions. He feels more settled and positive with AZD 9291 treatment so far. The results from other European trial centres has been encouraging showing 58 percent response even at lower dose. He feels it is worthwhile treatment with mild/moderate side effects.

DougGuitarPlayer :
My wife was treated with Tarceva since being diagnosed with Stage IV NSCLC on March 29th, 2013. As of today, the tumors are again growing and therefore becoming resistant to the Tarceva. Her doctor at Dana Farber recommends getting into the trial for AZD 9291, however, we were told that the trial at Dana Farber is currently closed, and may reopen in January 2014. It is not clear whether you will need to demonstrate a T790M mutation to be accepted into the trial. By the way, the recommended plan C was chemo and continue Tarceva for a period.

There was also some discussion whether getting into a Clovis trial would be a better option, but that is not offered at Dana Farber.

Given that we have few options we are hoping to hear some positive stories from the trials of AZD 9291.
===================================================================
Diceros ：
We live in the UK where AZD9291 is on clinical trial. My wife has been taking it for about six months. It has reduced her tumour by about two-thirds so far. The side effects have been minimal. The hope of course is that this drug will not only shrink the tumour but stop it regrowing and spreading.

老马 发表于 2013-12-7 01:14

                               
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DougGuitarPlayer :
My wife was treated with Tarceva since being diagnosed with Stage IV NSCLC on Ma ...

谢谢老马的辛苦,论坛有个翻译就好了,我大概看到这药效果很好啊,,

AZD9291患者第一次剂量递增研究
http://clinicaltrials.gov/show/NCT01802632
药物： AZD9291
起始剂量为20毫克，每日服用一次。如果容忍的同伙随后将测试增加剂量AZD9291的，直到最大耐受剂量或最大剂量是可行的定义


D.罗斯Camidge ，医学博士，主任，胸部肿瘤学临床课程，科罗拉多大学癌症中心，讨论我的研究看AZD9291治疗非小细胞肺癌的一个阶段。

AZD9291是表皮生长因子受体（EGFR ）激活和耐药突变的不可逆抑制剂，似乎被很好的耐受性试验。 Camidge说，他觉得很有趣，有些患者并有皮疹的一点点，这可能表明，研究人员已经接近理想的剂量。 AZD9291展示关于整体和大约56 ％的回应率在T790M突变阳性患者46％的回应率。

眼下， Camidge说， AZD9291可能是一个“改变游戏规则”，并预计快速通道审批。撤消修改

学习得很吃力，我是英盲

期待新药，感谢老马等人的辛勤付出

期待已久，感谢诸位！

My husband was treated with Tarceva ( erlotinib ) an EGFR inhibitor drug following diagnosed with Advanced stage Iv NSC Lung cancer for nearly 15 months after non responding to several courses of double agents chemotherapy. Unfortunately he developed resistant mutation and tarceva was no longer effective resulting in tumour progression and several metastatic lymph nodes enlargement . He was offered to participate in Phase I trial of AZD9291 drug developed by Astra Zenica. He is one of new participant on very dose AZD9291 ( 160 mg ) daily for the past 7-8 weeks his recent CT scan on 21/10/2013 has been promising. He had intractable diarrhoea & abdominal cramps associated with extreme tiredness & some weight loss with such high dose. He is now taking reduced dose 80 mg daily since 28/10/13 feel much better although still suffers from loose motions. He feels more settled and positive with AZD 9291 treatment so far. The results from other European trial centres has been encouraging showing 58 percent response even at lower dose. He feels it is worthwhile treatment with mild/moderate side effects.

在诊断出是晚期（stage IV）的NSCLC后，我丈夫先是接受了几个疗程的双药联合化疗，无效，之后服用了接近15个月的特罗凯。不幸的是，耐药还是出现了，特罗凯没有发挥出更长远的效果，这导致了肿瘤的进展，甚至转移到了远端的淋巴结上。他申请入组了9291的I期临床，是高剂量队列（160mg/day）的一员。在服用了7-8周之后，10月21日的CT显示效果很好。主要副作用是顽固性的腹泻和腹痛，以及极度的乏力和体重的减轻。从10月28日起，将剂量减为80mg每天，他感觉舒服很多，虽然还是有些拉肚子。至今他对9291感觉良好并且自觉病情稳定。来自欧洲其他临床中心的结果显示在低剂量队列都有58%响应率。相比较好的效果，他觉得这些比较温和的副作用都是非常值得的。

nbhstqw 发表于 2013-12-7 09:29
谢谢老马的辛苦,论坛有个翻译就好了,我大概看到这药效果很好啊,,

DougGuitarPlayer :
My wife was treated with Tarceva since being diagnosed with Stage IV NSCLC on March 29th, 2013. As of today, the tumors are again growing and therefore becoming resistant to the Tarceva. Her doctor at Dana Farber recommends getting into the trial for AZD 9291, however, we were told that the trial at Dana Farber is currently closed, and may reopen in January 2014. It is not clear whether you will need to demonstrate a T790M mutation to be accepted into the trial. By the way, the recommended plan C was chemo and continue Tarceva for a period.

There was also some discussion whether getting into a Clovis trial would be a better option, but that is not offered at Dana Farber.

Given that we have few options we are hoping to hear some positive stories from the trials of AZD 9291.
===================================================================
Diceros ：
We live in the UK where AZD9291 is on clinical trial. My wife has been taking it for about six months. It has reduced her tumour by about two-thirds so far. The side effects have been minimal. The hope of course is that this drug will not only shrink the tumour but stop it regrowing and spreading.

DougGuitarPlayer :
我的妻子于2013年4月29日诊断出是4期NSCLC，同时开始服用特罗凯。到今天，肿瘤又开始生长了，显示已经对特罗凯耐药了。她在丹娜法伯癌症研究院的医生建议她入组9291的临床。但是我们被告知，丹娜法伯的临床已经关闭了，要到2014年1月才可能重开。不清楚是否需要检测出有T790M的表达才能入组。顺便说一下，医生给的第三种建议是化疗之后继续服用特罗凯一段时间。

有一些讨论说可能CLVS的1686是个更好的选择，但丹娜法伯没有临床。

我们只有这些选择了，所以很希望能够听到来自9291临床的正面消息。


Diceros ：
我们来自英国，英国的9291已经开始临床了。我妻子已经服用了近6个月了。她体内的肿瘤缩小了三分之二，副作用几乎没有。希望这个药不仅仅能够缩小肿瘤，还能够阻止它再次生长和扩散。

期待中!