美国食品与药物管理局（FDA）批准Avastin联合卡铂和紫杉醇用于晚期非鳞状上皮细胞、非小细胞肺癌患者的初始治疗。
Avastin的临床作用
2004年，美国FDA首次批准了Avastin联合化疗用于已转移的结直肠癌患者。美国田纳西州纳什维尔市Vanderbilt-Ingram癌症中心胸部肿瘤研究室主任Alan Sandler博士在Genentech公司的新闻发布会上称，在一年多的大规模随机临床研究中，Avastin联合化疗是近10年内与标准一线方案和FDA首次批准方案相比，能够延长晚期肺癌患者生存期的第一个方案。Avastin用于晚期肺癌患者的批准正是由于它联合标准化疗可以延长患者的生存时间。
Avastin的作用机制
Avastin是一种基因工程单克隆抗体药物，它通过抑制能够刺激血管新生的血管内皮生长因子，使肿瘤组织失去血供，从而限制肿瘤生长，最终达到抗癌功效。
Avastin的临床研究
据Genentech公司报道，Avastin用于晚期肺癌患者的批准是基于一项研究，这项研究选用了878名晚期非鳞状细胞、非小细胞肺癌患者，这些患者在研究前均未接受过任何化疗。他们被随机分配到化疗组和Avastin联合化疗组。研究结果显示，接受Avastin联合化疗的患者51%的生存期在一年以上，而相比那些仅接受化疗的患者仅有44%。Avastin联合化疗的患者比单用化疗的患者总体生存期提高了25%。一般来说，接受Avastin联合化疗的患者生存期为1年，而只接受化疗的患者生存期仅为10个月。
Avastin的不良反应
据美国FDA，Avastin最严重的不良反应，包括胃肠道穿孔、伤口愈合障碍、出血、动脉闭塞、异常高血压、低蛋白血症、充血性心力衰竭及死亡。而接受Avastin治疗的患者最常见的不良反应包括头痛、乏力、恶心、呕吐、腹痛和腹泻。
http://www.cbsnews.com/stories/2006/10/12/health/webmd/main2086318.shtml
FDA OKs Drug For Advanced Lung Cancer
Avastin Already Approved For Treating Colorectal Cancer
(WebMD) The FDA has approved the colon cancer drug Avastin for use with chemotherapy in treating advanced lung cancer.
Avastin may now be used with the chemo drugs carboplatin and paclitaxel as an initial treatment for advanced cases of non-squamous, non-small cell lung cancer.
Lung cancer is the leading cause of cancer death for U.S. men and women.
Non-small cell lung cancer is the most common type of lung cancer. It accounts for three out of four of the 174,400 new cases of lung cancer that are expected to be diagnosed this year, according to the FDA.
"[The] FDA believes it is crucial for cancer patients to have many treatment options available to them in their battle against this disease," says the FDA's Richard Pazdur, M.D., in the FDA news release.
"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," Pazdur says.
Avastin Starves Tumors
Avastin, which is given intravenously, is not a new drug.
The FDA first approved it in February 2004 for use in combination with chemotherapy to treat metastatic colorectal cancer (cancer that has spread beyond the colon or rectum).
Avastin is believed to target a growth factor called VEGF (vascular endothelial growth factor). By blocking the action of VEGF, Avastin hampers the growth of new blood vessels that bring blood to tumors.
The strategy is to deprive tumors of their blood supply, thereby starving them. Such drugs are called angiogenesis inhibitors.
Avastin is made by Genentech.
Extended Survival
Avastin plus chemotherapy "is the first therapy in 10 years to improve on standard first-line treatment for advanced lung cancer and the first FDA approved therapy ever to extend survival for these patients beyond one year in a large, randomized clinical study," Alan Sandler, M.D., says in Genentech's news release.
Sandler headed the study upon which the FDA based Avastin's new approval. He is the director of medical thoracic oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn.
The American Cancer Society (ACS) also weighed in on Avastin's new approval.
"The approval of Avastin represents an important new option for patients with the most common type of lung cancer," says Len Licthenfeld, M.D., in an ACS statement.
Licthenfeld is the ACS' deputy chief medical officer.
"For decades, we've known that standard chemotherapy can improve survival for lung cancer patients, but we have not made improvements in survival beyond the gains made using that approach," Licthenfeld notes.
"That makes even the modest improvement in survival provided by Avastin important," he says.
Avastin's Study
Avastin's new approval is based on a study that showed a 25 percent improvement in overall survival in patients taking Avastin with chemotherapy, compared with chemotherapy alone, says Genentech.
That study included 878 patients with advanced non-squamous, non-small cell lung cancer.
The patients had not received chemotherapy before the study. They were randomly assigned to get chemotherapy or chemotherapy plus Avastin.
Fifty-one percent of those receiving Avastin plus chemotherapy survived for at least one year, compared with 44 percent of those who got chemotherapy without Avastin, according to Genentech.
On average, patients who received Avastin plus chemotherapy lived one year, compared with 10 months for patients treated with chemotherapy alone.
The FDA says the most serious adverse events associated with Avastin, including some deaths, were gastrointestinal perforations (holes in the stomach or intestines), wound healing complications, bleeding (hemorrhage), blockage of the arteries, abnormally high blood pressure, low blood levels of a protein called albumin, and congestive heart failure.
The most common aderse events in patients receiving Avastin included weakness, abdominal pain, headache, diarrhea, nausea, and vomiting, says the FDA.
SOURCES: News release, FDA. News release, Genentech. American Cancer Society statement attributed to Len Licthenfeld, MD, deputy chief medical officer, American Cancer Society. FDA: "Questions and Answers on Avastin." WebMD Medical Reference: "Avastin Questions and Answers."
By Miranda Hitti
Reviewed by Louise Chang
Copyright 2006, WebMD Inc. All rights reserved.
编辑：蓝色幻想
