Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update Journal Article


Authors: Choueiri, T. K.; Hessel, C.; Halabi, S.; Sanford, B.; Michaelson, M. D.; Hahn, O.; Walsh, M.; Olencki, T.; Picus, J.; Small, E. J.; Dakhil, S.; Feldman, D. R.; Mangeshkar, M.; Scheffold, C.; George, D.; Morris, M. J.
Article Title: Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update
Abstract: Background: The randomised phase 2 CABOSUN trial comparing cabozantinib with sunitinib as initial therapy for advanced renal cell carcinoma (RCC) of intermediate or poor risk met the primary end-point of improving progression-free survival (PFS) as assessed by investigator. We report PFS by independent radiology review committee (IRC) assessment, ORR per IRC and updated overall survival (OS). Patients and methods: Previously untreated patients with advanced RCC of intermediate or poor risk by IMDC criteria were randomised 1:1 to cabozantinib 60 mg daily or sunitinib 50 mg daily (4 weeks on/2 weeks off). Stratification was by risk group and presence of bone metastases. Results: A total of 157 patients were randomised 1:1 to cabozantinib (n = 79) or sunitinib (n = 78). Median PFS per IRC was 8.6 months (95% confidence interval [CI] 6.8–14.0) versus 5.3 months (95% CI 3.0–8.2) for cabozantinib versus sunitinib (hazard ratio [HR] 0.48 [95% CI 0.31–0.74]; two-sided p = 0.0008), and ORR per IRC was 20% (95% CI 12.0–30.8) versus 9% (95% CI 3.7–17.6), respectively. Subgroup analyses of PFS by stratification factors and MET tumour expression were consistent with results for the overall population. With a median follow-up of 34.5 months, median OS was 26.6 months (95% CI 14.6–not estimable) with cabozantinib and 21.2 months (95% CI 16.3–27.4) with sunitinib (HR 0.80 [95% CI 0.53–1.21]. The incidence of grade 3 or 4 adverse events was 68% for cabozantinib and 65% for sunitinib. Conclusions: In this phase 2 trial, cabozantinib treatment significantly prolonged PFS per IRC compared with sunitinib as initial systemic therapy for advanced RCC of poor or intermediate risk. Trial Registration Number: NCT01835158. © 2018 The Authors
Keywords: sunitinib; first-line; cabozantinib; advanced renal cell carcinoma; imdc risk groups
Journal Title: European Journal of Cancer
Volume: 94
ISSN: 0959-8049
Publisher: Elsevier Inc.  
Date Published: 2018-05-01
Start Page: 115
End Page: 125
Language: English
DOI: 10.1016/j.ejca.2018.02.012
PROVIDER: scopus
PUBMED: 29550566
PMCID: PMC6057479
DOI/URL:
Notes: Article -- Corrigendum issued, see DOI: 10.1016/j.ejca.2018.09.022 -- Export Date: 2 April 2018 -- Source: Scopus
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  1. Michael Morris
    512 Morris
  2. Darren Richard Feldman
    310 Feldman