Cabozantinib treatment prolonged progression-free survival (PFS) and improved objective response rate (ORR) compared with sunitinib in patients with advanced renal cell carcinoma (RCC) of intermediate or poor risk by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria in the phase II CABOSUN trial (NCT01835158). In the trial, 157 patients were randomized 1:1 to receive cabozantinib or sunitinib, stratified by IMDC risk group and presence of bone metastases. Here, PFS and ORR, both determined by independent radiology committee (IRC), were analyzed by subgroups of baseline characteristics. Cabozantinib treatment was generally associated with improved PFS and ORR versus sunitinib across subgroups, including in groups defined by IMDC risk group, bone metastases, age, and tumor burden. Clinical trial identification number NCT01835158.

The oncologist. 2019 Aug 09 [Epub ahead of print]

Daniel J George, Colin Hessel, Susan Halabi, M Dror Michaelson, Olwen Hahn, Meghara Walsh, Joel Picus, Eric J Small, Shaker Dakhil, Darren R Feldman, Milan Mangeshkar, Christian Scheffold, Michael J Morris, Toni K Choueiri

Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA ., Exelixis, Inc., Alameda, California, USA., Alliance Statistics and Data Center, and Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA., Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA., Alliance Protocol Operations Office, Chicago, Illinois, USA., Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA., Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri, USA., UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA., University of Kansas – Wichita, Wichita, Kansas, USA., Memorial Sloan Kettering Cancer Center, New York, New York, USA.