Sutent® (sunitinib) is safe and effective for a broad population of patients with metastatic renal cell carcinoma, according to the results of a trial published in Lancet Oncology.
The kidneys are each filled with tiny tubules that clean and filter the blood; this process removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney. Metastatic RCC refers to cancer that has spread from the kidney to distant sites in the body.
Sutent is an oral targeted agent that works by inhibiting multiple biologic pathways involved in the growth, replication, and spread of cancer cells. Sutent deprives cancer cells of blood and nutrients needed for growth.
Although Sutent has become standard for the first-line treatment of metastatic RCC, many patients are excluded from clinical trials because they have a poor prognosis or do not meet the inclusion criteria; therefore, the efficacy of Sutent in these subgroups is unclear.
A recent trial included 4,564 patients with metastatic RCC from 52 countries. The study included a broad population of patients who are often excluded from clinical trials: those with brain metastases, non-clear-cell RCC, with Eastern Cooperative Oncology Group (ECOG) performance status of two or higher, or those over age 65. Patients received a median of five treatment cycles, which consisted of 50 milligrams of oral Sutent for four weeks, followed by two weeks off.
There were 3,464 evaluable patients, and the objective response rate was 17%. Median progression-free survival was 10.9 months, and overall survival was 18.4 months. The most common side effects were diarrhea and fatigue.
The researchers concluded that Sutent is safe and tolerable in subgroups of patients who might otherwise have a lower tolerance to therapy. They suggest that this is encouraging for patients with a poor prognosis who are often excluded from trials.
 Gore ME, Szcylik C, Porta C, et al. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: An expanded-access trial. Lancet Oncology. 2009; 10: 757-763.
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