Source: Eur Urol  |  Posted 5 years ago

By Ed Susman

ATLANTA, G.A. -- June 4, 2006 -- Treatment with the targeted therapy sunitinib malate (Sutent) more than doubles the time to disease progression compared with interferon alfa in patients with renal cell cancer, researchers said here at the American Society of Clinical Oncology 2006 Annual Meeting (ASCO).

"Sunitinib is the new reference standard for the first-line treatment of metastatic renal cell cancer," said Robert Motzer, MD, attending physician, Memorial Sloan-Kettering Cancer Center, New York, New York, in a press briefing on June 4[^]th[].

In the phase 3, randomized trial, 335 patients with measurable clear cell kidney cancer were assigned to receive oral sunitinib subcutaneous injections of 9 million units 3 times a week and 327 patients to receive interferon alfa in 6-week cycles.

The median time to progression for patients on sunitinib was 11 months compared with 5 months for interferon alfa, Dr. Motzer said. That difference reached statistical significance at the []P []<.000001 level.

Dr. Motzer said 31% of patients on sunitinib achieved an objective clinical response compared with 6% of patients on the interferon regimen (103 patients vs 20 patients). Another 160 patients on sunitinib and 160 on interferon achieved disease stabilization.

"Sunitinib is superior to interferon in first-line treatment of metastatic renal cell cancer," the researcher said. "This is the first demonstration of benefit over cytokine treatment in a randomized phase 3 study."

There was significantly more diarrhea, hypertension, and hand-foot syndrome in sunitinib patients and significantly more fatigue among interferon patients, Dr. Motzer said. However, he added, most of the adverse effects were easily managed.

The study was supported by Pfizer Inc.

[[]Presentation title: Phase III Randomized Trial of Sunitinib Malate (SU11248) Versus Interferon-alfa (IFN-a) as First-Line Systemic Therapy for Patients With Metastatic Renal Cell Carcinoma (mRCC). Abstract LBA3[]]