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Analysis of High-Risk Subgroup in ASSURE Trial of Sunitinib or Sorafenib in Renal Cell Carcinoma

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Key Points

  • No disease-free survival benefit of adjuvant sunitinib or sorafenib was observed among all patients in the ASSURE trial.
  • No benefit in these outcomes was observed with either agent among high-risk patients.

In an analysis of the phase III ASSURE trial reported in JAMA Oncology, Haas et al found no disease-free or overall survival benefit of adjuvant sunitinib (Sutent) or sorafenib (Nexavar) vs placebo in a high-risk subset of patients with clear cell renal cell carcinoma histology and pT3, pT4, or node-positive disease. No disease-free survival benefit with adjuvant therapy was observed among all patients in ASSURE, the largest adjuvant study of vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors to date in this setting. Another recent trial showed a disease-free survival benefit with sunitinib in a similar high-risk population.

Study Details

The current analysis included 1,069 high-risk patients from U.S. and Canadian cooperative groups participating in the trial. Patients had been randomized to receive 1 year of daily sunitinib at 50 mg, sorafenib at 800 mg, or placebo. The study drug doses were amended for intolerance to sunitinib (37.5 mg) and sorafenib (400 mg), with mandatory dose escalation in the absence of serious adverse events.

Among these patients, 358 (68% men, 32% women) received sunitinib, 355 (70% men, 30% women) received sorafenib, and 356 (71% men, 29% women) received placebo.

Disease-Free and Overall Survival

Five-year disease-free survival rates were 47.7% with sunitinib (hazard ratio [HR] = 0.94, P = .54, vs placebo), 49.9% with sorafenib (HR = 0.90, P = .30, vs placebo), and 50.0% with placebo. Five-year overall survival rates were 75.2% with sunitinib (HR = 1.06, P = .66), 80.2% with sorafenib (HR = 0.80, P = .12), and 76.5% with placebo. There were no differences in these outcomes for sunitinib or sorafenib vs placebo in analysis by dose-intensity quartile.

The investigators concluded: “Neither prognostic category of the tumor nor dose intensity of therapy altered the lack of difference in [disease-free survival] or [overall survival] in this population of patients with high-risk [clear-cell renal cell carcinoma].”

The study was supported by grants from the National Cancer Institute and the Department of Health and Human Services.

Naomi B. Haas, MD, of Abramson Cancer Center, University of Pennsylvania, is the corresponding author of the JAMA Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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