Dr. Haas on Adjuvant VEGF-Targeted Therapy in RCC

Naomi B. Haas, MD, director, Prostate and Kidney Cancer Program Associate Professor of Medicine at the Hospital of the University of Pennsylvania, discusses results of 2 ongoing clinical trials looking at adjuvant therapy options in renal cell carcinoma (RCC).

There are currently 8 adjuvant clinical trials in the United States and Europe, Haas explains. In the last 2 years, 2 of those trials have reported data. One of them, the ASSURE trial, which was a randomized study of sunitinib (Sutent), sorfaenib (Nexavar), or placebo for 1 year. Patients enrolled on the trial were divided by cohorts of intermediate- and high-risk classification with clear cell and non-clear cell histology. Following approximately 1300 patient accrual, there was a higher discontinuation rate than expected due to toxicity and intolerability. Due to this, the study was amended to include patients with a -1 dose level with a mandatory dose escalation.

The second study, the S-TRAC trial, enrolled patients with clear cell histology with a slightly higher risk stratification who were treated with 1 year of full-dose sunitinib versus placebo. The study was not amended; all patients started at the full dosage. A dose reduction was permitted at 37.5, Haas says. This trial had an endpoint of disease-free survival, which was reported as positive, Haas explains.

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