ESMO 2017: Adjuvant sunitinib in patients with high risk renal cell carcinoma (RCC): Safety and therapy management in S-TRAC trial

Madrid, Spain ( Dr. Michael Staehler and colleagues presented a post-hoc analysis of the S-TRAC trial assessing adjuvant sunitinib in patients with high risk renal cell carcinoma (RCC). As the author’s note, patients in S-TRAC with locoregional RCC at high risk (≥T3 and/or N+) of tumor recurrence post nephrectomy treated with adjuvant sunitinib (50 mg daily; schedule 4/2) had significantly longer disease-free survival (DFS) vs. placebo (HR 0.76; 95%CI, 0.59–0.98; p = 0.03) [1]. The objective of this analysis was to report safety and therapy management outcomes from this trial.

Among the 615 patients enrolled in S-TRAC, 306 were treated with sunitinib at a median daily dose of 45.9 mg (range: 8.9-52.6). The majority (71%) of patients remained on sunitinib treatment for 9 months and 56% completed the full 1-year treatment. Reasons for sunitinib treatment discontinuation, dose reduction, dose interruption, and treatment discontinuation due to adverse events by cycle were assessed, as was median time to sunitinib treatment discontinuation. In this study, the most common reasons for treatment discontinuation were adverse events (28.1%) and disease relapse (7.2%) in sunitinib arm, and disease relapse (19.4%) and adverse events (5.9%) in the placebo arm. The most common adverse event leading to treatment discontinuation (4.2%), dose reduction (11.8%) and dose interruption (6.2%) was palmar-plantar erythrodyesthesia syndrome. Treatment discontinuation due to adverse events in cycles 1, 3, 6, and 9, respectively were 7.8%, 3.3%, 2.6%, and 1.6% in sunitinib arm, and 0.3%, 1.3%, 0.3%, and 0% in placebo arm. Among the 86 patients who discontinued sunitinib, the median time to treatment discontinuation was 4.5 months, while the median time to first dose reduction and dose interruption in sunitinib-treated patients was 2.9 and 3.0 months, respectively. Mean change from baseline for most patient reported outcome measures including Global Health Status for sunitinib vs placebo was not clinically meaningful (difference, -4.76; 95% CI, -6.82, -2.71). 

In this post-hoc analysis of S-TRAC data, no new safety signals were identified with sunitinib use in the adjuvant RCC setting. The authors concluded that effective therapy management, including dose reduction/interruption if necessary, is important as it optimizes the possibility of receiving effective treatment.

Speaker: Michael Staehler, Ludwig-Maximilians University, Munich, Germany

Co-Authors: R. J. Motzer (New York, United States of America) D. J. George (Durham, United States of America) H. S. Pandha (Surry, United Kingdom) F. Donskov (Aarhus, Denmark) B. Escudier (Villejuif, France) J. Kliment (Martin, Slovak Republic) A. J. Pantuck (Los Angeles, United States of America) A. Patel (London, United Kingdom) L. Deannuntis (Collegeville, United States of America) H. Bhattacharyya (New York, United States of America) X. Lin (La Jolla, United States of America) M. Lechuga (Milan, Italy) L. Serfass (Paris, France) J. Patard (Mont-de-Marsan, France) A. Ravaud (Bordeaux, France)

Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre, Twitter: @zklaassen_md at the European Society for Medical Oncology Annual Congress - September 8 - 12, 2017 - Madrid, Spain

1. Ravaud A, Motzer RJ, Pandha HS, et al. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med 2016;375(23):2246-2254.