Sutent improves survival in renal cell carcimoma patients who can avoid surgery. Pfizer.

Data from the Phase III CARMENA trial evaluating Sutent (sunitinib) from Pfizer Inc. showed that patients with renal cell carcinoma (RCC) could avoid nephrectomy without compromising survival. The data were presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago.

CARMENA enrolled 450 patients with synchronous metastatic RCC to receive Sutent alone or Sutent 4-6 weeks after surgery. The open-label, French, non-inferiority trial was sponsored by Assistance Publique - H�pitaux de Paris and was conducted in collaboration with Pfizer.The researchers said, "In addition to putting patients at risk for complications, including blood loss, infection, pulmonary embolism and heart problems, nephrectomy delays medical treatment for people with advanced kidney cancer for weeks. In some cases, the cancer worsens so rapidly during this delay that there is no time to start systemic treatment."

On the trial's primary endpoint, Sutent alone led to a median overall survival (OS) of 18.4 months vs. 13.9 months for nephrectomy followed by Sutent at a median follow-up of 50.9 months (HR=0.89). Median progression-free survival (PFS) was 8.3 months for Sutent alone vs. 7.2 months for nephrectomy followed by Sutent, and the objective response rate (ORR) was 35.9% in both treatment arms.

Comment: "Until now, nephrectomy has been considered the standard of care for patients with kidney cancer who have metastatic disease when the cancer is first diagnosed," said Arnaud Mejean, lead study author and a urologist at H�pital Europ�en Georges-Pompidou. "Our study is the first to question the need for surgery in the era of targeted therapies and clearly shows that surgery for certain people with kidney cancer should no longer be the standard of care."