People with advanced liver cancer lived about 3 months longer when given the drug Nexavar (sorafenib) compared to those given a placebo, according to new research. In a presentation at the annual meeting of the American Society of Clinical Oncology, researchers said the drug should become the new standard of care for this form of cancer.

"This is the first time that we've had an effective systemic treatment for liver cancer," said lead study author Josep Llovet, MD, director of liver cancer research at Mt. Sinai School of Medicine in New York and professor of research at the Institut d'Investigacions Biomediques August Pi i Sunyer Hospital Clinic in Barcelona, Spain. "Our findings demonstrate survival advantages that are both statistically significant and clinically meaningful."

Llovet's study involved 602 people with hepatocellular carcinoma, the most common form of liver cancer. This is a type of cancer that begins in the liver, as opposed to cancers that have spread there from other parts of the body.

The study participants all had advanced disease, which is very difficult to treat. There is no standard therapy for liver cancer that has spread to other parts of the body and cannot be removed by surgery or has come back after surgery.

"We don't have much to offer patients in these circumstances," acknowledged Len Lichtenfeld, MD, deputy chief medical officer for the American Cancer Society.

In Llovet's study, patients were randomly assigned to receive either Nexavar, a pill taken twice a day, or daily placebo pills.

People on Nexavar lived nearly 11 months, while those on placebo lived about 8 months. It also took significantly longer for the liver tumors to begin growing again in the patients on Nexavar: 5.5 months compared to 2.8 months for those on placebo.

Overall, side effects were similar in the two groups. People taking Nexavar had more cases of diarrhea and skin reactions on the hands and feet.

Nexavar's manufacturers, Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, now plan to ask the US Food and Drug Administration to approve the drug for people with liver cancer. It is already approved for advanced kidney cancer.

Citation: "Sorafenib improves survival in advanced hepatocellular carcinoma: Results of a Phase III randomized placebo-controlled trial (SHARP trial)." Presented June 4, 2007, at the annual meeting of the American Society of Clinical Oncology. First author: Josep Llovet, MD, Mt. Sinai School of Medicine, New York.