Dr. Rini on Axitinib for Treatment of Metastatic Renal Cell Carcinoma

Brian Rini, MD, associate professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, discusses a phase Il study that examined axitinib as a frontline therapy for metastatic renal cell carcinoma (mRCC).

The randomized dose titration study enrolled approximately 200 patients with mRCC. Patients were first treated with the standard dose at 5 mg twice daily for 30 days. Criteria to be randomized to receive an increased dosage included a lack of incidence of toxicity and/or hypertension.

Patients were then randomized to an increased dose of axitinib versus placebo, which was the standard dose. A 20% advantage in response rate was demonstrated in the titration arm. Progression-free survival and overall survival was favored in the titration arm, but was not found to be statistically significant. Researchers determined that dose titration needs to be carefully done so as to not harm patients with higher levels of toxicities.