Cabozantinib Versus Sunitinib for Untreated Patients with Advanced Renal Cell Carcinoma of Intermediate or Poor Risk: Subgroup Analysis of the Alliance A031203 CABOSUN trial

Author:

George Daniel J.1,Hessel Colin2,Halabi Susan3,Michaelson M. Dror4,Hahn Olwen5,Walsh Meghara6,Picus Joel7,Small Eric J.8,Dakhil Shaker9,Feldman Darren R.10,Mangeshkar Milan2,Scheffold Christian2,Morris Michael J.10,Choueiri Toni K.6

Affiliation:

1. Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA

2. Exelixis, Inc., Alameda, California, USA

3. Alliance Statistics and Data Center, and Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA

4. Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA

5. Alliance Protocol Operations Office, Chicago, Illinois, USA

6. Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA

7. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri, USA

8. UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA

9. University of Kansas – Wichita, Wichita, Kansas, USA

10. Memorial Sloan Kettering Cancer Center, New York, New York, USA

Abstract

Abstract 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.

Funder

Dana-Farber Harvard Cancer Center Kidney SPORE and Program

Exelixis Inc.

Loker Pinard Funds for Kidney Cancer Research at the Dana-Farber Cancer Institute

Memorial Sloan Kettering Cancer Center Support Grant Core Grant

Michael Brigham

National Institutes of Health

The Kohlberg Chair at Harvard Medical School and the Trust Family

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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