美国FDA宣布将Nexavar（索拉非尼）用于治疗无法手术切除的肝细胞癌。该药最早于2005年被批准用于治疗晚期肾细胞癌（肾癌的一种）。

FDA肿瘤药物处主任Robert Justice说，在对无法切除的肝细胞癌患者进行的临床随机试验中，接受Nexavar治疗的患者比不用药的患者生存期长2.8个月。对于与这种难治性癌症抗争的患者来说，这是一个非常重要的新选择。

根据国家医学图书馆的资料，肝细胞癌占全部肝癌的80%-90%，仅仅使用外科手术很难完全切除。如果癌灶不能被全部切除，那么生存期通常只有3-6个月。美国癌症协会估计到2007年，美国将新增19160例病例，其中16780名患者将死于肝癌和肝内胆管癌。

Nexavar是一种激酶类的抗癌药，能够阻断多种分子，例如癌细胞内传递化学信号的分子、供养肿瘤的血管形成分子、与细胞死亡有关的分子等。

研究人员对无法切除的肝细胞癌患者进行了一项国际随机安慰剂对照试验，在此次研究成果的基础上，美国FDA批准了Nexavar。该试验的目的是比较接受药物治疗和不使用药物的患者生存期。

此次试验共包括602名患者，每名患者要么使用Nexavar，要么使用安慰剂。两组患者在年龄、性别、种族、肝癌的分期和其他特点、参与试验前接受的治疗类型等方面都具有可比性。

当接受Nexavar的患者总体生存期呈现明显的统计学优势时，研究人员停止了该试验。接受Nexavar的患者平均生存期为10.7个月，而接受安慰剂的患者平均生存期仅为7.9个月。一项独立分析表明，与接受安慰剂的患者相比，接受Nexavar治疗的患者肿瘤进展速度明显更慢。

通过观察使用Nexavar（用于肝细胞癌和肾细胞癌）的患者，我们发现最常见的不良反应有乏力、体重减轻、皮疹或皮屑、手足皮肤反应、脱发、腹泻、食欲减退、恶心和腹痛等。20%以上（包括20%）的患者至少出现一项上述不良反应。在肝细胞癌患者中，有55%的患者出现腹泻；心肌缺血和心脏病发作的概率在Nexavar组和安慰剂组中分别为2.7%和1.3%；新出现高血压的概率分别为9%和4%；血清脂肪酶（一种反应肝功能的酶）升高的概率分别为40%和37%；低磷酸盐血症的发生率则分别为35%和11%。

Nexavar为200mg的片剂，常用剂量为每日两次（400mg），空腹服用。该药由德国拜尔制药公司生产。

FDA Approves Nexavar for Patients with Inoperable Liver Cancer
　　
　　 The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.

"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,” said Robert Justice, M.D., director of FDA's division of drug oncology products. "This is an important new treatment option for patients who are fighting this very difficult form of cancer."

According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months. The American Cancer Society estimates that there will be 19,160 new cases and 16,780 deaths from cancer of the liver and intrahepatic bile duct in the United States in 2007.

Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.

FDA's approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.

A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.

The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.

　　The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions.

In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo. Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.

Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach.
　　Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.