Drug delays kidney cancer progression in phase III trial
TUESDAY 20 MAY 2008
A phase III clinical trial involving the experimental drug everolimus (RAD001) suggests that it may significantly delay the progress of kidney cancer in patients whose tumours have spread.
The drug is taken orally once a day. It targets a protein called mTOR, which regulates how cancer cells divide and break down food as well as the growth of blood vessels or "angiogenesis".
The study, which was conducted at the Memorial Sloan-Kettering Cancer Centre (MSKCC) in the US, involved more than 400 patients, all of whom had kidney cancer that had progressed despite treatment.
Patients were either given everolimus or a placebo and the impact of the drug was evaluated after six months.
The researchers found that cancer had not progressed in 26 per cent of patients on everolimus, compared with only two per cent of those taking the placebo.
Side-effects were uncommon and included mouth ulcers, anaemia, skin rash and weakness.
The results were so promising that the trial was stopped after these interim results and patients who were receiving the placebo were given the option to switch to everolimus.
Lead researcher Dr Robert Motzer, an attending physician at MSKCC, will present the findings at the annual meeting of the American Society for Clinical Oncology on May 31st.
He commented: "For almost 20 years, we made no headway in the management of advanced kidney cancer.
"Recently, the identification of several new angiogenesis-targeted agents has provided us with new treatment options and an improved outlook for patients with advanced kidney cancer.
"Based on the results of this trial, everolimus could become another tool in our armamentarium and, in the future, kidney cancer is likely to be managed as a chronic disease with these types of treatment advances."
Everolimus is also being evaluated for the treatment of several other cancers, including lymphoma and neuroendocrine tumours.
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