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Written by Theresa Maher   
Friday, 01 June 2007
The most common form of kidney cancer is called renal cell carcinoma. This accounts for at least 90 percent of all kidney tumors found in man. Yesterday the U.S. Food and Drug Administration (FDA) approved a drug called Torisel (temsirolimus) for the treatment of this particular cancer.

According to American Cancer Society estimates, 51,190 new cases of kidney cancer will be diagnosed in the United States in 2007, while 12,890 people will succumb to the cancer. Renal cell carcinoma is mostly prevalent between the ages 55 to 84 and is very rarely diagnosed before the age of 45 years.

While the rate of incidence of this cancer is on the rise in the last few years, the ACS says mortality rates of kidney cancer have not shown a corresponding increase. However most cancer drugs are approved on the basis of their ability to prolong the survival rates in affected patients and the new drug called Torisel is no different.

The drug is chemically temsirolimus and acts by inhibiting an enzyme that is responsible for cell proliferation and survival. Torisel is manufactured by Wyeth Pharmaceuticals.

The FDA approval was based on a study that showed the drug increased the survival rates in 626 patients affected by renal cell carcinoma. The patients were divided into three groups. The first group received temsirolimus, while the second group was given an older drug called interferon. The third group was asked to take a combination of both these drugs.

The study, which was presented at the annual meeting of the American Society of Clinical Oncology last June, appears in the May 31 issue of the New England Journal of Medicine.

The researchers found that patients who received temsirolimus had a median survival time of 10.9 months as compared to kidney cancer patients who received interferon alone. The latter group had a median survival time of 7.3 months. Renal cell carcinoma patients who received a combination of both drugs survived for a period of 8.4 months, the study said.

Dr. Gary R. Hudes, the lead author of the NEJM study revealed that patients in the combination group had received a lower dose of temsirolimus as compared to the group that was given temsirolimus alone. He theorized that this may have been the cause for the combination group's lower survival rate.

The standard treatment for kidney cancer is surgery to remove the tumor. However in 35 percent of the cases, the cancer returns with increased intensity and hence drugs like temsirolimus are useful in prolonging life.

Torisel was generally well tolerated with rash, fatigue, mouth sores, nausea, edema, and loss of appetite being the main adverse effects. On a laboratory basis, researchers found high blood sugar, elevated blood lipids and triglycerides, elevated liver and kidney blood tests, and low red cell, white cell, and platelet counts in patients who received Torisel.

Torisel is the latest addition in the arsenal of drugs against kidney cancer. The FDA had approved Nexavar (sorafenib) in December 2005 because it was found to delay the progress of kidney cancer. The agency approved January 2006, Sutent (sunitinib) in January last year based on its ability to reduce tumor size and delay tumor progression.

Dr Hudes opined that Torisel could be more effective in patients who have limited spread of kidney cancer, but cautioned that randomized clinical trials were needed to further judge this effect.

 


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