The new drug everolimus works by interfering with the mTOR protein, which acts as a central regulator of tumor cell division, cell metabolism, and blood vessel growth. Because it targets a different molecular pathway than the other drugs, it provides an alternative method of attacking the tumor cells. Everolimus is taken as a once-a-day pill and, in addition to kidney cancer, is currently being tested in clinical trials for the treatment of lymphoma and neuroendocrine tumors.
Everolimus Trial Results
A recent international, multicenter Phase III clinical trial tested the effectiveness of everolimus in patients whose metastatic kidney cancer had worsened after receiving sunitinib or sorafenib. Of the more than 400 patients enrolled in the trial, 272 were randomly selected to receive everolimus while 138 received placebos.
Six months into the trial, tumors had not grown or spread for 26 percent of patients receiving everolimus, compared to only 2 percent of patients receiving placebo. The average progression free survival was four months for patients taking everolimus, compared to 1.9 months for patients receiving placebo. Because of these positive interim results, which were presented at the May 31 annual meeting of the American Society for Clinical Oncology, an independent monitoring committee halted the trial in February 2008, allowing researchers to offer everolimus to the group of patients receiving placebo.
As a result of the trial, study author Robert Motzer, MD, an attending physician at Memorial Sloan-Kettering, believes that once everolimus receives approval by the Food and Drug Administration, it will become an important new tool for treating kidney cancer -- improving both disease management and quality of life for people living with the disease. Dr. Motzer notes that results like these provide new research leads and the possibility of using these drugs in earlier stages of treatment.
