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Sunitinib Found Effective, Safe in Advanced Kidney Cancer

Last Updated: July 17, 2009.

In patients with advanced or metastatic renal cell carcinoma with poor prognosis who are not usually entered into clinical trials, sunitinib significantly prolongs progression-free and overall survival and is well-tolerated, according to a study published online July 16 in The Lancet Oncology.

FRIDAY, July 17 (HealthDay News) -- In patients with advanced or metastatic renal cell carcinoma with poor prognosis who are not usually entered into clinical trials, sunitinib significantly prolongs progression-free and overall survival and is well-tolerated, according to a study published online July 16 in The Lancet Oncology.

Martin E. Gore, M.D., of the Royal Marsden Hospital NHS Trust in London, and colleagues studied the effects of 50 mg of sunitinib once daily in repeated six-week cycles of four weeks of treatment followed by two weeks off in 4,564 patients, including 321 with brain metastases, 582 with poor performance status, 588 with non-clear-cell renal cell carcinoma, and 1,418 ages 65 and older.

Overall, the researchers found that sunitinib was associated with significantly improved median progression-free and overall survival (10.9 and 18.4 months, respectively) and an objective response rate of 17 percent. They also observed that the most common treatment-related adverse events were diarrhea (44 percent) and fatigue (37 percent).

"We have shown that sunitinib is safe and toxicity manageable in subgroups of patients that might otherwise have lower tolerance to therapy," the authors conclude. "Efficacy appears to be consistent with the benefits shown in prospective renal-cell carcinoma studies. These results should encourage the study of targeted agents in subgroups of patients otherwise excluded from trials and, therefore, potentially disadvantaged."

This study was supported by Pfizer Inc.; several authors reported financial relationships with Pfizer and other pharmaceutical companies.

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