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【medical-news】FDA批准用于肺癌的新联合疗法
FDA Approves New Combination Therapy for Lung Cancer
FDA批准用于肺癌的新联合疗法
The U.S. Food and Drug Administration (FDA) approved the use of Avastin (bevacizumab) in
combination with carboplatin and paclitaxel for the initial systemic treatment of patients with
unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung
cancer. This approval was based on an improvement in survival time when Avastin was added
to a standard chemotherapy regimen.
美国食品和药品管理局( FDA )批准使用阿瓦斯丁（贝伐单抗）联合卡铂和紫杉醇用于首次治疗患有具有不可切除性、局部晚期、周期性或者转移性的非鳞状上皮内瘤病变、非小细胞性肺癌患者， 这个批准是基于在标准性化疗中加入阿瓦斯丁可以延长患者的生存时间。
Non-small cell lung cancer accounts for 75 percent of the174,400 new cases of lung cancer that are expected to be diagnosed this year. Lung cancer is the leading cause of cancer-related death in men and women.
据估计在今年可能新诊断出174400名肺癌患者，其中非小细胞肺癌约占75%的比例， 无论是男性还是女性，肺癌都是癌症相关性死亡的主要因素。
"FDA believes it is crucial for cancer patients to have many treatment options available to them in their battle against this disease," said Richard Pazdur, M.D., Director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "With the approval of Avastin, patients with this type of lung cancer will not only have access to another treatment option, but one that has been shown in clinical trials to increase survival time."
“FDA坚信对于那些在于癌症进行着斗争的患者而言拥有更多的治疗方案的选择无疑是至关重要的”FDA药品评价与研究中心、肿瘤学药品办公室主任Richard Pazdu博士认为：”随着阿瓦斯丁的批准,这种类型的肺癌患者将不仅有机会得到另外一种的治疗选择，而且这样的治疗已经在临床试验显示可以延长生存时间。
The multi-center clinical trial supporting this approval enrolled 878 patients who had not received prior chemotherapy. The median age of the patients was 63, and 46 percent were women. The trial compared the effectiveness of Avastin plus carboplatin and paclitaxel with chemotherapy by carboplatin and paclitaxel alone. The main outcome measure of the study was duration of survival.
多中心临床试验中登记在案的878名先前没有接受过化疗的患者的临床实验结果支持了这一批准。这些患者的平均年龄为63，其中46%是妇女。 试验中用阿瓦斯丁联合卡铂和紫杉醇化疗和单用卡铂和紫杉醇化疗效果进行对比。以生存时间做为研究的主要测定结果。
The median overall survival time for patients in the Avastin plus carboplatin and paclitaxel arm was 12.3 months versus 10.3 months for patients receiving only carboplatin and paclitaxel.
The most serious adverse events associated with Avastin, including some that were fatal, were gastrointestinal perforation, wound healing complications, hemorrhage, blockage of the arteries, abnormally high blood pressure, albumin deficiency in the blood and congestive heart failure. The most common adverse events in patients receiving Avastin included weakness, abdominal pain, headache, diarrhea, nausea and vomiting.
阿瓦斯丁联合卡铂和紫杉醇的平均生存时间为12.3个月，与之相对的单用卡铂和紫杉醇的为10.3个月。
与阿瓦斯丁相关的主要的严重不良反应（包括一些致命性的副作用）是胃肠道穿孔，创口愈合并发症，出血，动脉阻塞，引发性高血压，血液白蛋白降低，出血，心脏病。 普遍的病人可接受的不良反应包括无力，腹痛，头痛，腹泻，恶心和呕吐。
Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, was previously approved for first- or second-line treatment of patients with metastatic cancer of the colon or rectum. ，
阿瓦斯丁与静脉注射5-氟尿嘧啶为基础的化疗联合治疗，是早先被批准的用于治疗结肠或直肠的转移性的癌症患者的一线或二线用药。
Avastin is manufactured by Genentech, Inc., in South San Francisco, Calf.
阿瓦斯丁由Genentech, Inc., in South San Francisco, Calf.制造
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01488.html http://www.dxy.cn/bbs/post/view?bid=116&id=7255308&sty=1&tpg=2&age=0
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作者:admin@医学,生命科学 2010-12-24 05:11
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