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 authors noted.
In an article accompanying the study, experts added that "the safety and efficacy of sunitinib in an older population are confirmed and evidence shows that age alone should not be a deterrent from attempting therapy."
But "patients with brain metastases, non-clear-cell histology, and poor performance status benefit less from sunitinib, despite good drug tolerance, suggesting the need for prospective studies in these subpopulations," wrote Dr. Joaquim Bellmunt of Hospital del Mar in Barcelona, Spain, and the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and Dr. Toni K. Choueiri of Dana-Farber and Harvard.
"Thus, claiming sunitinib as a 'standard' in these subgroups remains controversial. An oncologist might not have access to such trials in practice, however, and based on available information the use of sunitinib may be justified in these subpopulations," they concluded.
The U.S. National Cancer Institute has more about kidney cancer.
-- Robert Preidt
SOURCE: The Lancet Oncology, news release, July 15, 2009
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