Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Presidential Symposium 3

1518 - CABOzantinib versus SUNitinib (CABOSUN) as initial targeted therapy for patients with metastatic renal cell carcinoma (mRCC) of poor and intermediate risk groups: Results from ALLIANCE A031203 trial


10 Oct 2016


Presidential Symposium 3


Toni Choueiri


Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435


T.K. Choueiri1, S. Halabi2, B. Sanford2, O. Hahn3, M..D. Michaelson4, M. Walsh1, T. Olencki5, J. Picus6, E.J. Small7, S. Dakhil8, D. George9, M.J. Morris10

Author affiliations

  • 1 Kidney Cancer Center, Dana-Farber Cancer Institute, MA 02215 - Boston/US
  • 2 Biostatistics & Bioinformatics, Duke University, 27710 - Durham/US
  • 3 Medical Oncology, The University of Chicago Medical Centre, 60637 - Chicago/US
  • 4 Medical Oncology, Massachusetts General Hospital, Boston/US
  • 5 Medical Oncology, Ohio State Univ Medical Center, 43210 - Columbus/US
  • 6 Medical Oncology, Washington University School of Medicine, 63110 - St Louis/US
  • 7 Medical Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco/US
  • 8 Hematology, Cancer Center of Kansas, Wichita/US
  • 9 Medical Oncology, Duke University, 27710 - Durham/US
  • 10 Medical Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York, NY/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 1518


Cabozantinib (Cabo) is an oral, potent inhibitor of MET, AXL and VEGFR2 that increases progression free-survival (PFS) and overall survival (OS) in mRCC patients (pts) after VEGF-targeted therapy. This randomized phase II multicenter trial compared the PFS of Cabo to Sunitinib (Sun) as front-line targeted therapy in pts with mRCC.


Eligible pts had untreated clear-cell mRCC, ECOG performance status 0-2, and were intermediate or poor risk, per the International mRCC Database Consortium Criteria (IMDC, Heng JCO 2009). Pts were randomized 1:1 to Cabo (60 mg QD) or Sun (50 mg QD, 4 weeks on/2 weeks off). Pts were stratified by IMDC risk groups (intermediate vs. poor risk) and bone metastasis (yes, no). With 123 events (progression or deaths), the log-rank statistic has 85% power to detect a hazard ratio of 0.67 for PFS assuming a one-sided type I error of 0.12.


From July 2013 to April 2015, 157 pts were randomized (79 to Cabo and 78 to Sun). Median follow up was 20.8 months (mo). 13 (16.46%) pts remained on therapy in the Cabo arm vs. 2 (2.56%) pts in the Sun arm. 80.9% of pts were IMDC intermediate risk and 36.3% had bone metastases and were equally distributed across arms. Median PFS was significantly increased at 8.2 mo (95% CI = 6.2-8.8) for Cabo vs. 5.6 mo (95% CI = 3.4-8.2) for Sun, with 31% reduction in rate of progression or death (adjusted HR 0.69, 95% CI 0.48 to 0.98, one-sided P = 0.012). ORR was 46% (95% CI 34-57%) for Cabo vs. 18% (95% CI 10-28%) for Sun. Median OS was 26.4 mo. for Cabo vs. 23.5 mo for Sun (adjusted HR 0.87, 95% CI 0.55-1.4). All-causality grade 3 or higher adverse events were 70.5% for Cabo and for 72.2% for Sun, and included diarrhea (Cabo 10%, Sun 11%), fatigue (Cabo 6%, Sun 15%), hypertension (Cabo 28%, Sun 22%), palmar-plantar erythrodysesthesia (Cabo 8%, Sun 4%) and hematological (Cabo 2.6%, Sun 22.2%). In each arm, 16 pts ended treatment due to toxicity.


Cabozantinib demonstrated a significant benefit in PFS and ORR over standard sunitinib in untreated intermediate and poor risk mRCC pts.

Clinical trial identification


Legal entity responsible for the study





T.K. Choueiri: Institutional funds from Exelixis and Pfizer. Advisory board compensation from Pfizer. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings