ORLANDO, FL, USA (UroToday.com) - The ASSURE trial enrolled 1 943 patients with intermediate-high risk kidney cancer, including grade 3-4 pT1b; any grade T2, T3, or T4; or any grade and T stage with clinically positive but resectable nodes. Patients with metastatic disease were excluded, and all patients were required to have complete resection via laparoscopic or open partial or radical nephrectomy. Patients were stratified by risk, histology, ECOG performance status, and resection approach, and were randomized to receive sunitinib, sorafenib, or placebo for 1 year. The primary endpoints was DFS, and the study was powered to detect a 25% reduction in HR corresponding to improvement of 5.8 to 7.7 median DFS. Other endpoints included OS and adverse events.
At interim analysis, the investigators found median DFS of 5.8 years in both treatment arms and 6 years in the placebo arm for no difference in survival (HR 0.98 for sorafenib, 1.01 for sunitinib). Similarly, there was no difference in OS. Most common grade 3 and higher adverse events were hypertension (16% in both treatment arms, 4% placebo), hand-foot reaction (15% sunitinib, 33% sorafenib, 1% placebo), rash (2%, 15%, 1%), and fatigue (17%, 7%, 3%).
The authors concluded that in patients with locally advanced, resected RCC, adjuvant treatment with sorafenib or sunitinib should not be pursued.
Presented by Naomi B. Haas, Judith Manola, Robert G. Uzzo, Michael B. Atkins, George Wilding, Michael Pins, Michael A. S. Jewett, Christopher J. Kane, David Cella, Lynne I. Wagner, Bob Coomes, Christopher G. Wood, Janice P. Dutcher, Keith Flaherty, and Robert S. DiPaola at the 2015 Genitourinary Cancers Symposium - "Integrating Biology Into Patient-Centric Care" - February 26 - 28, 2015 - Rosen Shingle Creek - Orlando, Florida USA
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA; Fox Chase Cancer Center, Philadelphia, PA; Lombardi Comprehensive Cancer Center, Washington, DC; University of Wisconsin Carbone Cancer Center, Madison, WI; University of Illinois College of Medicine, Chicago, IL; Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada; Moores Cancer Center, University of California, San Diego, La Jolla, CA; Northwestern University Feinberg School of Medicine, Chicago, IL; Cancer Research Patient Advocate, Atlanta, GA; The University of Texas MD Anderson Cancer Center, Houston, TX; Our Lady of Mercy Cancer Center, Bronx, NY, New York, NY; Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Rutgers Biomedical and Health Sciences, New Brunswick, NJ
Reported by Nikhil Waingankar, MD, medical writer for UroToday.com