Dr. Haas on Adjuvant VEGF-Targeted Therapy in RCC

Naomi B. Haas, MD
Published: Saturday, Nov 05, 2016



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.
 

<<< View more from the 2016 International Kidney Cancer Symposium



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.
 

<<< View more from the 2016 International Kidney Cancer Symposium


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