Targeted therapy shows promise in advanced RCC patients

Treatment with sunitinib malate (Sutent) appears to prolong progression-free and overall survival, and is safe and well tolerated in advanced kidney cancer patients with a poor prognosis, including the elderly and those whose cancer has spread to the brain, according to a study to be published in The Lancet Oncology.

The oral targeted drug inhibits tumor growth and angiogenesis.

The international, expanded-access trial included subgroups of patients with advanced kidney cancer not usually entered into clinical trials or those being treated in countries where the drug is not yet approved.

In total, 4,564 patients from 52 countries were recruited between June 2005 and December 2007. These included four subgroups of patients with brain metastases (321 patients), poor performance status (582 patients), non-clear-cell renal cell carcinoma (588 patients), and patients age 65 years or older (1,418 patients). All received sunitinib, 50 mg once daily in repeated 6-week cycles of 4 weeks of treatment followed by 2 weeks off. Tumor response, toxicity, and adverse events were assessed at regular intervals.

Median progression-free and overall survival rates were 10.9 and 18.4 months, respectively. The overall objective response rate was 17%.

Results also showed that sunitinib is safe and well tolerated in patients who might be expected to have a lower tolerance to therapy than the broader advanced kidney cancer patient population. The safety profile was similar to that reported in previous trials, and the overall incidence of adverse events was slightly less.

The authors say that these results should "encourage the study of targeted agents in subgroups of patients otherwise excluded from trials and, therefore, potentially disadvantaged."