Entremed (ENMD)

[georgejjl]

Angiogenesis and kidney cancer From today's news

"Experimental Drug Improves Survival in Advanced Kidney Cancer
Temsirolimus Submitted for FDA Approval

Article date: 2007/05/31


Summary: The experimental drug temsirolimus helps people with advanced kidney cancer live longer than standard treatment with interferon, according to researchers from Philadelphia's Fox Chase Cancer Center. The drug's maker, Wyeth, has already asked the US Food and Drug Administration to approve it; a decision should come by July.

Why it's important: Advanced kidney cancer is notoriously hard to treat. Stage IV disease typically has spread too far to be cured by surgery. Chemotherapy is usually not helpful, so immune system therapy with interferon or interleukin-2 is often used instead. Unfortunately, only 10%-20% of patients respond to this therapy and it has severe side effects. New treatments are needed.

What's already known: Patients with advanced kidney cancer survive on average about 4-8 months when treated with interleukin-2 or interferon. Temsirolimus is a targeted drug that disrupts tumor growth signals and blood vessel formation (angiogenesis). In early studies, the drug appeared to help people with kidney cancer that did not respond to interferon or interleukin-2. At a cancer conference last year, the Fox Chase researchers presented preliminary data showing that temsirolimus improved survival in people with advanced disease.

How this study was done: Now, these researchers have published their full findings in the respected New England Journal of Medicine. The study involved 626 people with stage IV or recurrent renal cell carcinoma (kidney cancer) and a poor survival outlook. Participants were randomly assigned to treatment with either interferon alone, temsirolimus alone, or a combination of both drugs. Their progress was tracked for nearly 2 years.

What was found: People assigned to temsirolimus lived longer -- about 11 months -- than people on interferon alone (about 7 months) or people on both drugs (about 8 months). Side effects were not as severe in the temsirolimus group as they were in the other groups and were generally manageable. People on temsirolimus were more likely to experience rashes, swelling of the feet, ankles, and legs, and mouth sores. High blood sugar and high cholesterol were also more common among people who took temsirolimus. Those on interferon alone were more likely to have severe weakness and fevers.

The bottom line: Although temsirolimus only improved survival by a few months, it improved it for people with the most advanced kind of tumors whose outlook has typically been very grim, notes lead researcher Gary R. Hudes, MD.

"This is the first study to show that a new drug can improve overall survival for patients with metastatic renal cell cancer," he says in a statement. "For these patients, the goal of treatment is to prevent further spread and growth of the cancer, and ideally, to reduce that amount of cancer. Until recently, physicians lacked effective drugs to control the disease."

Because temsirolimus works as well as it does in patients with very advanced disease, Hudes says it might work even better in patients with earlier-stage kidney cancer. However, large randomized trials of such patients will be needed to know for sure."

http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Experimental_Drug_Improves_Survival_in_Advanced_K....

Good luck and God bless,

George