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发表于 2007-2-13 17:16

Nexavar shown to significantly extend survival for patients with advanced liver cancer
Trial to be stopped early based on positive outcome
 
West Haven, CT and Emeryville, CA ?February 12, 2007 ?Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from the companies' pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. Based on this planned interim analysis, the DMC has concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar?(sorafenib) tablets versus those patients receiving placebo. The DMC also noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early.

As a result of this recommendation, Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar. Given that there are limited approved systemic therapies for this disease, the companies will continue discussions with health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and European health authorities regarding the next steps in filing for approval for the treatment of HCC. Following these discussions, the companies will proceed to file as rapidly as possible. The two companies also reported that they plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.

"The observed superiority in overall survival for Nexavar-treated patients over patients receiving placebo demonstrates the efficacy of Nexavar in advanced primary liver cancer," said Dr. Jordi Bruix, co-principal investigator and Head of the Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona, Spain.

Dr. Josep M. Llovet, co-principal investigator and Associate Professor of Medicine/Director, HCC Research Program, Division of Liver Diseases, Mount Sinai School of Medicine, New York, and Professor of Research at Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona added, "These results point to new potential treatment options for those patients suffering from this devastating disease."

可十一:24 所以我告诉你们,凡你们祷告祈求的,无论是什么,只要信是得着的,就必得着。 太七:7-8 你们祈求,就给你们。寻找,就寻见。叩门,就给你们开门。 因为凡祈求的,就得着。寻找的,就寻见。叩门的,就给他开门。

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发表于 2007-2-13 17:17
可十一:24 所以我告诉你们,凡你们祷告祈求的,无论是什么,只要信是得着的,就必得着。 太七:7-8 你们祈求,就给你们。寻找,就寻见。叩门,就给你们开门。 因为凡祈求的,就得着。寻找的,就寻见。叩门的,就给他开门。

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发表于 2007-2-13 18:10

索拉非尼Sorafenib

肝细胞肝癌在我国是一种常见的恶性肿瘤,手术切除目前是对于早前期患者最主要的治疗方法。对于失去手术机会的晚期患者来讲,药物治疗成为其主要的治疗方式之一。近年来出现的分子靶向药物治疗越来越受到人们的关注。
    分子靶向药物通过阻断肿瘤细胞或相关细胞的信号转导,来控制细胞基因表达的改变,而产生抑制或杀死肿瘤细胞。它的最大的优点是以肿瘤细胞或与之相关的细胞为靶向点,选择性地抑制或杀死肿瘤细胞。
    索拉非尼是一种通过在Raf激酶和受体酪氨酸激酶VEGFR-2 和PDGFR-β水平阻断Raf/MEK/ERK途径,来抑制肿瘤细胞增殖和血管生成的新型靶向抗肿瘤药物。在已有的临床研究中,索拉非尼表现出了对于多种恶性肿瘤良好的治疗效果,并在2005年底被美国食品药品监督管理局批准治疗晚期肾细胞癌。 到目前为止,全球共有超过8000例癌症患者接受了索拉非尼的治疗。
    在既往国外针对肝细胞肝癌的研究中,我们发现服用索拉非尼的患者的生存期以及生活质量均得到了明显的提高。
    我国有10家大医院正在进行一项“Sorafenib治疗进展期肝细胞癌患者的随机、双盲、安慰剂对照的研究” ,本项临床研究是在中国大陆、中国台湾以及韩国进行的III期临床研究,旨在明确索拉非尼在亚洲肝细胞肝癌患者中的有效性和安全性。试验得到了中国食品药品监督管理局和参加医院伦理委员会的批准。
    如果您的肝癌患者已无其他更好的治疗选择,且基本符合以下入选标准,请推荐给下述的国内研究者,以使您的患者在该研究中获得可能的益处:
    1.18岁或18岁以上的患者(男女不限);
    2.患者的预期寿命至少为12周;
    3.患者患有无法切除和/或转移性进展期肝细胞癌,肝细胞癌的诊断经组织学或者细胞学确诊
    4.患者必须具有至少一个肿瘤病灶并且同时符合以下两条标准:
    (1)根据实体肿瘤反应评估标准(RECIST),病灶至少有一条径线可以被精确测量.
    (2)靶病灶既往没有接受过任何的局部治疗(包括手术、放射治疗、肝动脉灌注、栓塞化疗、射频消融、
经皮乙醇注射和冷冻消融).
    5.   接受过局部治疗的患者可以纳入,包括手术、放疗、肝动脉栓塞、栓塞化疗、射频消融、经皮酒精注射或冷冻消融。但是必须明确研究的靶病灶不在既往治疗范围内,或经过局部治疗后病灶至少增大25%,局部治疗需在入组前至少4周前结束.
    6. 符合以上条件的患者推荐到研究中心后,研究者会向患者详细介绍此研究,并在获得患者的知情同意后再进行研究相关步骤


附:国内研究者和联系电话
中心名称 中心地址 研究者 联系方式
中山大学肿瘤医院 广州市东风东路651号
中山大学肿瘤医院 邮编:510060 管忠震 教授  
徐立 主治医师  
南方医院 广州大道北1838号
邮编:510515 罗荣城 教授  
陈锦章 主治医师  
中国医学科学院肿瘤医院 北京朝阳区潘家园医科院肿瘤医院 邮编:100021 孙燕 教授  
李青 主任医师
樊英 主治医师  
北京307医院 北京丰台区东大街 8号 邮编:100071 徐建明 教授 010-66947176
李月敏 副主任医师 010-66947177
大连医科大学附属第一医院肿二科 辽宁省大连市中山路标222号 邮编:116011 刘基巍 教授  
谭小新 副主任医师  
解放军南京八一医院 江苏省南京市杨公井34标34号 邮编:210002 秦叔逵 教授  
华海清 主任医师  
第三军医大学西南医院 重庆沙坪坝高滩岩正街30号 邮编:400038 梁后杰 教授  
黄海辉 教授  
上海长征医院 上海和田路64号 邮编:200070 王杰军 教授  
孙莉  
复旦大学中山医院 上海医学院路136号 邮编:200032 叶胜龙 教授  
张岚 主治医师  
安徽医科大学附属第一医院 安徽省合肥市绩溪路218号 邮编:230022 陈振东 教授  
杜瀛瀛 主治医师

http://www.hbvhbv.com/forum/viewthread.php?tid=630683

实事求是,注重科学,坚持真理,敢讲真话
敢为人先,务实进取,开放兼容,敬业奉献

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发表于 2007-2-13 18:15
中巴合作的泰欣生的靶点也是EGFR,已经上市
实事求是,注重科学,坚持真理,敢讲真话
敢为人先,务实进取,开放兼容,敬业奉献

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发表于 2007-2-13 18:16

多吉美-索拉非尼|Nexavar|sorafenib

英文商品名:Nexavar 英文通用名:sorafenib

实事求是,注重科学,坚持真理,敢讲真话
敢为人先,务实进取,开放兼容,敬业奉献

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荣誉之星 心爱宝宝

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发表于 2007-2-16 08:15

索拉非尼二线治疗转移性肾透明细胞癌较安慰剂明显延长患者的无进展生存期和总生存期, 因此, 已获得美国FDA批准.这是近十多年来世界上被批准的治疗晚期肾癌的第一个新药, 是晚期肾癌治疗的重大进展

 临床研究的初步结果表明, 索拉非尼对肝癌、黑色素瘤、非小细胞肺癌和卵巢癌等实体瘤均有一定的抗肿瘤作用。一项肝癌的Ⅱ期临床试验中, 137例患者接受了索拉非尼治疗, 结果7例患者获得PR,5例MR, 总生存期280天, 中位无进展生存期123天。

索拉非尼具有潜在广谱的抗肿瘤作用, 目前的临床研究结果已证实索拉非尼对晚期肾细胞癌的二线治疗有
明显延长TTP的作用, 但其作为一线治疗和术后辅助治疗的疗效有待进一步的研究。索拉非尼对其他肿瘤的疗效还需要观察; 如何进一步提高这类药物的疗效(如与化疗药物联合) 无疑也是目前临床试验正在研究的问题。

有时会治愈,常常去帮忙,总是去安慰 BEST WISHES

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发表于 2007-6-6 00:06

http://www.nctimes.com/articles/2007/06/05/health/16_21_046_4_07.txt

Liver cancer patients get hope from kidney cancer drug, study shows pill improves survival

CHICAGO -- For the first time, doctors said Monday they have found a pill that improves survival for people with liver cancer, a notoriously hard to treat disease diagnosed in more than half a million people globally each year.

The results in a multinational study of 602 patients with advanced liver cancer are impressive and likely will change the way patients are treated, say cancer specialists, including the study authors.

Patients got either two tablets daily of a drug called sorafenib or dummy pills in the study, which started in March 2005. Some patients are still alive, although on average, sorafenib patients survived 10.7 months versus almost 8 months for those on dummy pills.

That type of survival advantage "has never happened" with liver cancer "and is a major breakthrough in the management of the disease," said Dr. Josep Llovet, the lead author.

"That may not sound like a lot of time," but for liver cancer, "this is actually a quite impressive gain," said Dr. Nancy Davidson of Johns Hopkins' Bloomberg School of Public Health. "It is the first effective systemic treatment for liver cancer, which is such a huge problem internationally."

The results were released Monday at the American Society of Clinical Oncology's annual meeting.

"We now have moved forward" in treating advanced liver cancer "when it was not really possible before," Dr. William Blackstock of Wake Forest University School of Medicine said at a press briefing about the study.

Sorafenib attacks cancer with a targeted double-barreled approach. It zeros in on malignant cells themselves and cuts off the blood supply feeding the tumor. It is believed to work on tumors within the liver and those that have spread elsewhere.

In the study, tumors didn't shrink or disappear but in many cases they also didn't grow.

"You are not curing the disease but you are delaying the progression of the disease significantly and strikingly," said Llovet, of Mount Sinai School of Medicine in New York and Hospital Clinic of Barcelona, Spain.

The study was halted early in February because of the good results, and patients on dummy pills were switched to sorafenib.

"This is a very good step forward in this disease," said Dr. Emily Chan of Vanderbilt-Ingram Cancer Center in Nashville, Tenn.

The drug, sold under the brand name Nexavar, is approved in the United States and dozens of other countries to treat advanced kidney cancer. It is marketed by Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc., which funded the liver cancer study. They hope to receive approval for liver cancer use from U.S. and foreign regulators.

Llovet has done consulting for the sponsors.

Liver cancer is diagnosed in about 19,000 Americans annually but is much more common elsewhere and is the fifth most common cancer globally. Risk factors include chronic liver infections and some forms of hepatitis. The disease is common in China and countries without widespread use of the hepatitis B vaccine, which is routinely given to U.S. infants.

Liver cancer doesn't respond well to conventional chemotherapy and is often diagnosed too late for surgery to be an option. Many patients die within a year of diagnosis.

Robert Throckmorton, a 73-year-old attorney in Orange County, Calif., said his doctor told him "You better get your affairs in order" after he was diagnosed with inoperable liver cancer last August.

But then the doctor offered sorafenib off-label, and Throckmorton readily agreed. He did not take part in the study.

After nine months on the drug, Throckmorton said his cancer shows no sign of progression and he has no significant side effects. He said he walks three miles six days a week to stay active and feels fine.

Instead of thinking about wills and funerals, Throckmorton is looking forward to get-togethers with his eight children and 18 grandchildren, and even a possible church trip to Uruguay with his wife.

"I have good energy," Throckmorton said. "We are optimistic."

可十一:24 所以我告诉你们,凡你们祷告祈求的,无论是什么,只要信是得着的,就必得着。 太七:7-8 你们祈求,就给你们。寻找,就寻见。叩门,就给你们开门。 因为凡祈求的,就得着。寻找的,就寻见。叩门的,就给他开门。
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