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

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, 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

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.

Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

© 2019 The Authors. The Oncologist published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

Figures

Figure 1.
Figure 1.
Forest plot of progression‐free survival by subgroups. All analyses are per independent radiology committee. Hazard ratios are unstratified with the exception of the analysis for all patients. Metastatic sites are per investigator. *Eight patients in the cabozantinib group and 18 patients in the sunitinib group had unknown MET status. †Ten patients in the cabozantinib group and 10 patients in the sunitinib group were Eastern Cooperative Oncology Group (ECOG) 2. Abbreviations: CI, confidence interval; HR, hazard ratio; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; NE, not estimable; PFS, progression‐free survival; SoD, sum of diameters.
Figure 2.
Figure 2.
Forest plot of objective tumor response by subgroups. All analyses are per independent radiology committee. Metastatic sites are per investigator. *Eight patients in the cabozantinib group and 18 patients in the sunitinib group had unknown MET status. †Ten patients in the cabozantinib group and 10 patients in the sunitinib group were Eastern Cooperative Oncology Group (ECOG) 2. Abbreviations: CI, confidence interval; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; SoD, sum of diameters.

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Source: PubMed

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