Objectives: To study the effects of adjuvant therapy in patients with sarcomatoid renal cell carcinoma (sRCC) enrolled in the randomised phase III clinical trial E2805. Patients and Methods: The original trial (E2805) was a randomised, double-blinded phase III clinical trial comparing outcomes in 1943 patients with RCC accrued between 2006 and 2010 and treated with up to 1 year of adjuvant placebo, sunitinib, or sorafenib. The present study analyses the cohort of patients with sRCC that participated in E2805. Results: A total of 171 patients (8.8%) had sarcomatoid features. Of these, 52 patients received sunitinib, 58 received sorafenib, and 61 received placebo. Most patients were pT3–4 (71.1%, 63.7%, and 70.5%, respectively); 17.3%, 19.0%, and 27.9% had pathologically positive lymph nodes; and 59.6%, 62.1%, and 62.3% of the patients were University of California Los Angeles (UCLA) Integrated Staging System (UISS) very-high risk. In 49% of patients with subsequent development of metastatic disease, recurrence occurred in the lung, followed by 30% in the lymph nodes, and 13% in the liver. There was a high local recurrence rate in the renal bed (16%, 29%, and 18%, respectively). The 5-year disease-free survival (DFS) rates were 33.6%, 36.0%, and 27.8%, for sunitinib, sorafenib and placebo, respectively (hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.45–1.20 for sunitinib vs placebo, and HR 0.82, 95% CI 0.53–1.28 for sorafenib vs placebo). Conclusions: Adjuvant therapy with sunitinib or sorafenib did not show an improvement in DFS or OS in patients with sRCC.
|Number of pages||5|
|State||Published - Jun 2022|
Bibliographical noteFunding Information:
Dr. Karam reports personal fees from Pfizer, Merck, Johnson and Johnson and research grants to MD Anderson from Merck, Mirati, Roche/Genentech, Elypta, other from MedTek, outside the submitted work; Dr. Wood reports personal fees and other from Pfizer, Inc. other from CoImmune, other from Mirati, during the conduct of the study; Dr. Matin reports personal fees from Johnson and Johnson, Merck, outside the submitted work; Dr. Uzzo reports personal fees from Janssen, UroGen; non‐financial support from Pfizer, Genentech, Amgen during the conduct of the study.
This study was coordinated by the ECOG‐ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co‐Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: U10CA180820, U10CA180794, U10CA180888, U10CA180821, U10CA180863, Canadian Cancer Society #704970, UG1CA233239, UG1CA233180. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
© 2021 The Authors BJU International © 2021 BJU International.
- adjuvant therapy
- kidney cancer
ASJC Scopus subject areas