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Sunitinib Benefit Explored in Poor-Prognosis Kidney Cancer
Date:7/16/2009

Treatment safe in advanced disease but more study is needed, experts say

THURSDAY, July 16 (HealthDay News) -- The oral cancer drug sunitinib (Sutent) has shown promising results in advanced kidney cancer patients who have a poor prognosis, new research says.

Previous clinical trials showed that sunitinib was effective in patients with advanced kidney cancer, and the drug has been approved worldwide as a first- and second-line treatment for these patients, according to background information with the study. However, little is known about the drug's activity in advanced kidney cancer patients with poor prognosis, such as those whose cancer has spread to the brain, those with poor performance status, and the elderly.

The new study, published online and in the August print issue of The Lancet Oncology, included 4,564 poor-prognosis patients in 52 countries who were divided into four subgroups, including those with brain metastases, poor performance status, non-clear-cell renal cell carcinoma, and patients aged 65 and older.

All of the patients received 50 milligrams of sunitinib once daily, repeated in six-week cycles (four weeks on treatment followed by two weeks off treatment). The researchers assessed tumor response, toxicity, and adverse events at regular intervals.

The study authors reported that the median progression-free survival was 10.9 months, and overall survival was 18.4 months, which was an improvement over previous findings. In the four subgroups, the response rates were: brain metastases, 12 percent; non-clear-renal cell carcinoma, 11 percent; poor performance status, 9 percent; and elderly, 17 percent; with an overall objective response rate of 17 percent.

Overall, the study found that the drug can be given safely and is well-tolerated in all four subgroups. Diarrhea (44 percent) and fatigue (37 percent) were the most common treatment-related adverse events, the study author
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