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楼主: amei

肺癌脑转准备尝试拉帕替尼特别请jimmy进来看看

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发表于 2008-5-22 12:28:04 | 显示全部楼层 来自: LAN
QUOTE:
以下是引用amei在2008-5-22 11:52:35的发言:
顶一下,听医生说全脑放疗后3个月血脑屏障可以打开这个时候可以使用利比泰,不知有无依据?我记得好像说是全放后6个月脑屏障打

还有这种说法啊!意思是有些以前通不过的药放疗后能通过血脑屏障吗?

amei,最近看你一直在找脑转的治疗方案,现在怎么治疗的啊?

有爱,就有奇迹!
 楼主| 发表于 2008-5-22 12:50:42 | 显示全部楼层 来自: 美国

雁南飞,我现在在用拉帕提尼,刚吃了几天,也许是还在用地米的原因,症状一直在好转,地米我开始减量了。

jimmy:麻烦你知道关于泰欣生联合化疗治疗脑转的消息么?主治的意见是联合利比泰。

           看你说C225+拉帕提尼可以用来作为特罗凯耐药后的选择,不知泰欣生+拉帕提尼+利比泰是否可行?

[此贴子已经被作者于2008-5-22 12:53:35编辑过]
有爱,就有奇迹!
发表于 2008-5-23 12:07:40 | 显示全部楼层 来自: 美国
QUOTE:
以下是引用amei在2008-5-22 11:52:35的发言:
顶一下,听医生说全脑放疗后3个月血脑屏障可以打开这个时候可以使用利比泰,不知有无依据?我记得好像说是全放后6个月脑屏障打开的吧

我咨询了一下, 回复如下:
It’s not really known. As I mention above, there is some evidence that
patients who respond in the chest to chemo also often have a response
in the brain, with a similar response rate as for the rest of the body,
so chemo definitely can be effective in the brain as well.

这不是完全清楚的知道的。正如我上述提到的情况,有一些  证据表明,患者 在胸部化疗有效往往对脑转也有效,有效率也 与身体其余的部分类似,,所以化  疗对脑转一定能够有效。


amei:在这里我说明一下,过去认为化疗不能通过血脑屏障,但最新的结果显示,化疗对脑传也有效,有效率和身体其余的部分类似
[此贴子已经被作者于2008-5-27 8:55:41编辑过]
有爱,就有奇迹!
发表于 2008-5-23 12:46:38 | 显示全部楼层 来自: 美国
泰欣生联合放疗的结果
Positive Results From Phase I/II Cancer Trial Of Nimotuzumab Combined With Radiation

Cancer Treatment

Nimotuzumab Combined With Radiation

YM BioSciences announced positive preliminary results from the first two cohorts of the Phase I part of a Phase I/II trial of nimotuzumab in combination with radiation for the treatment of non-small-cell lung cancer (NSCLC) patients who are unsuitable for radical chemotherapy. The data were reported on September 5th in a poster presentation at the 12th World Conference on Lung Cancer in Seoul, Korea. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR).

"While preliminary, these results are compelling because we observed clinical benefit (Partial Response or Stable Disease) in every one of the 13 patients so far enrolled in this study. A study by The National Cancer Institute of Canada demonstrated that patients with advanced NSCLC with Stable Disease as best response for treatment had Overall Survival similar to patients with Partial Response. The relatively long survival times observed in the first cohort of this trial are encouraging and are in agreement with the NCIC observations," said Dr. Igor Sherman, YM's Director of Clinical Research. "Although nimotuzumab specifically targets the EGF receptor, the reported absence of side effects, particularly the absence of severe rash, makes nimotuzumab therapeutically attractive in this setting."

The Phase I component enrolled patients at three centers in Canada and is evaluating the safety and feasibility of administrating nimotuzumab at three dose levels (100mg, 200mg and 400mg weekly) with palliative radiation (30 Gy in 10 fractions). The data will be used to select the optimal effective dose for the randomized Phase II component of the study, in which Overall Survival will be the primary endpoint.

Of the six patients enrolled in the 1st cohort (100mg), four Partial Response (PR) and two Stable Disease (SD) were reported as at August 14, 2007. Median Overall Survival of the group was 41.5 weeks. All patients ultimately progressed. Two severe adverse events have been reported, neither causally attributable to nimotuzumab. A notable absence of grade III/IV rash or diarrhea in this cohort was reported.

Of the seven patients enrolled in the 2nd cohort (200mg) of the study, two PR and five SD were reported as at August 14, 2007 Median overall survival of the group has not been reached but currently exceeds 25 weeks. There has been a notable absence of grade III/IV rash or diarrhea reported in this cohort.

Enrolment is now ongoing into the third cohort, to be treated at 400 mg per dose level, and accrual is anticipated to be completed by the end of 2007.

YM is conducting the trial in Canada and Kuhnil Pharmaceutical Co. is conducting a parallel trial in Korea with a common protocol. This structure is designed to accelerate overall recruitment and lower the costs to the participants. The interim report from Phase I Korean patients is anticipated early in 2008.

The poster presentation is entitled "Preliminary Results Of An Escalating Dose (Phase I /II Clinical) Trial Of The Anti EGFR Monoclonal Antibody Nimotuzumab In Combination With External Radiotherapy In Patients Diagnosed With Stage IIB, III or IV NSCLC Unsuitable For Radical Therapy" by Gwyn Bebb, Colum Smith, Anthony Brade, Stewart Rorke and Igor Sherman. The poster, P3 - 023, will be on display on September 5 & 6 at Atlantic Halls 5 - 8 in poster session 3 - Novel Therapeutics: Molecular Therapeutics.

Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). To date nimotuzumab has been administered to approximately 900 patients in more than a dozen clinical trials and on a compassionate basis. It has been approved in several countries and is being provided on a compassionate basis in certain countries including Canada, Germany and Australia. The drug continues to demonstrate a significantly superior side-effect profile compared to all the other EGFR-targeting antibodies and small molecules targeting the EGF tyrosine kinase signalling pathway. The absence of any cases of severe rash to date and the very rare instances of any of the other debilitating side effects holds the prospect for nimotuzumab to become best-in-class for this important family of EGFR-targeting agents.
有爱,就有奇迹!
 楼主| 发表于 2008-5-23 12:52:27 | 显示全部楼层 来自: 美国
谢谢jimmy,你的资料太及时了,我也是只查到了泰欣生联合放疗的资料,有联合化疗的资料么?
有爱,就有奇迹!
发表于 2008-5-23 12:58:01 | 显示全部楼层 来自: 美国
欧洲正在作泰欣生联合化疗的3期试药,但我查不到泰欣生联合化疗的1期或2期试药结果
有爱,就有奇迹!
发表于 2008-5-24 15:59:04 | 显示全部楼层 来自: 美国
泰欣生单药治疗脑癌初步结果: 服药8星期后,总有效率38%。

YM Biosciences USA enrolls first patient of phase II trial of Nimotuzumab in children with inoperable, recurrent brain cancer

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URL: http://ymbiosciences.com/presspop.cfm?newsID=5492

For more information about the trial, see:
http://clinicaltrials.gov/ct2/show/NCT00600054

MISSISSAUGA, Canada – February 13, 2008 – YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that its wholly-owned US subsidiary, YM BioSciences USA Inc. (“YM-USA”) has enrolled the first patient in its Phase II trial investigating nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG), a form of inoperable, treatment-resistant brain cancer. The patient was treated at the M.D Anderson Cancer Center under the care of Dr. Johannes Wolff. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR).

“We are very pleased that this trial is underway in the expectation that nimotuzumab will benefit the children suffering from this insidious form of brain cancer for which there are currently no effective treatments,” said David Allan, Chairman and CEO of YM BioSciences. “If nimotuzumab continues to perform as it has in previous trials, it has the potential to improve clinical outcomes and, particularly, without inflicting the serious side effects that have been reported for the other drugs in its class.”

Eight leading US pediatric clinical centers and two Canadian centers will be participating in the single-arm trial, which is designed to enroll 44 patients with DIPG who will be treated with nimotuzumab as monotherapy. The primary endpoint of the current trial is Response Rate, with a target of 15%, and recruitment is expected to be completed within approximately 18 months.

Positive data from a completed Phase II nimotuzumab monotherapy trial in Europe that included pediatric patients with this recurrent form of brain cancer were reported in an oral presentation at ASCO, 2007. In the 21 patients with DIPG, the clinical benefit rate, which included Partial Response and Stable Disease, was 38% after eight weeks of treatment. Of the eight patients who continued on treatment to week 21, three were assessed with a Partial Response and one with Stable Disease. The Company is not aware of any previous clinical trials that reported Objective Responses in recurrent DIPG.

Recruitment in a Phase III trial combining nimotuzumab with radiation for the first-line treatment of children with DIPG, conducted by Oncoscience AG (YM’s European licensee for nimotuzumab) was completed in August 2007. The primary end-point of the Phase III trial is Progression-Free Survival with Overall Survival as a secondary endpoint. YM anticipates that data from this trial will be available mid-2008 and, if positive, are expected to be supportive of an application in 2008 for marketing approval in Europe. An application for marketing authorization of nimotuzumab based on earlier stage data was submitted to EMEA by Oncoscience AG on October 4th, 2007.

Nimotuzumab in combination with radiation-containing regimens has been demonstrated to be effective in other indications for which it is already approved in certain jurisdictions. The clinical benefit of nimotuzumab as monotherapy in a range of patients refractory to all treatments was also published in the proceedings at ASCO, 2007 in addition to the presentation of the pediatric results.

The US investigational trial sites participating in the international Phase II trial include leading pediatric neuro-oncology centers that are members of POETIC (Pediatric Oncology Experimental Therapeutics International Consortium): Vanderbilt Children’s Hospital/Vanderbilt-Ingram Cancer Center; M.D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; the Sidney Kimmel Cancer Center at Johns Hopkins; the Children’s Hospital at the University of Colorado and the University of Florida Children’s Hospital. In addition, the University of Rochester Medical Center and the New York University Medical Center are participating in the trial. In Canada, clinical sites include the Hospital for Sick Children in Toronto, where Drs. Eric Bouffet, Sylvain Baruchel, and Ute Bartels lead the international program, and Alberta’s Children’s Hospital in Calgary.

About Nimotuzumab

Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). To date nimotuzumab has been administered to more than 2000 patients and evaluated in more than a dozen clinical trials. It has been approved in several countries and has been provided on a compassionate basis in a number of countries including the US, Canada, Germany, and Australia. The emerging safety data for nimotuzumab suggests a more benign side-effect profile in its trials with radiation-containing regimens compared to currently approved EGFR targeting antibodies and small molecules. To date, in patients treated with nimotuzumab, there has been no evidence of severe rash or any life-threatening adverse events. The unique safety profile for nimotuzumab holds the prospect for it to become best-in-class within this important family of EGFR-targeting agents.

Nimotuzumab has been designated an Orphan Drug by the US FDA and by the EMEA for glioma.

About YM BioSciences

YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company has two late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer; and AeroLEFÔ, a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.

This press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEFÔ will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwi
有爱,就有奇迹!
 楼主| 发表于 2008-5-26 15:13:36 | 显示全部楼层 来自: 美国
看了一下泰欣生的说明书要求做免疫组化,看egfr基因是否突变,因为我家人易瑞沙和特罗凯的使用效果都不好,不知道是否意味着egfr基因没有突变,那么使用泰欣生是否效果会不好呢?
有爱,就有奇迹!
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