Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database

I. Wolff, M. May, B. Hoschke, R. Zigeuner, L. Cindolo, G. Hutterer, L. Schips, O. De Cobelli, B. Rocco, C. De Nunzio, A. Tubaro, I. Coman, B. Feciche, M. Truss, O. Dalpiaz, R. S. Figenshau, K. Madison, M. Sánchez-Chapado, M. D C Santiago Martin, L. SalzanoG. Lotrecchiano, S. F. Shariat, M. Hohenfellner, R. Waidelich, C. Stief, K. Miller, S. Pahernik, S. Brookman-May

Research output: Contribution to journalArticle

Abstract

Background Since there is still an unmet need for potent adjuvant strategies for renal cancer patients with high progression risk after surgery, several targeted therapies are currently evaluated in this setting. We analyzed whether inclusion criteria of contemporary trials (ARISER, ASSURE, SORCE, EVEREST, PROTECT, S-TRAC, ATLAS) correctly identify high-risk patients. Methods The study group comprised 8873 patients of the international CORONA-database after surgery for non-metastatic renal cancer without any adjuvant treatment. Patients were divided into potentially eligible high-risk and assumable low-risk patients who didn't meet inclusion criteria of contemporary adjuvant clinical trials. The ability of various inclusion criteria for disease-free survival (DFS) prediction was evaluated by Harrell's c-index. Results During a median follow-up of 53 months 15.2% of patients experienced recurrence (5-year-DFS 84%). By application of trial inclusion criteria, 24% (S-TRAC) to 47% (SORCE) of patients would have been eligible for enrollment. Actual recurrence rates of eligible patients ranged between 29% (SORCE) and 37% (S-TRAC) opposed to

Original languageEnglish
Pages (from-to)744-750
Number of pages7
JournalEuropean Journal of Surgical Oncology
Volume42
Issue number5
DOIs
Publication statusPublished - May 1 2016

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Keywords

  • Adjuvant therapy
  • Disease recurrence
  • Nephrectomy
  • Phase-3-trials
  • Renal cell cancer
  • Targeted agents

ASJC Scopus subject areas

  • Oncology
  • Surgery

Cite this

Wolff, I., May, M., Hoschke, B., Zigeuner, R., Cindolo, L., Hutterer, G., Schips, L., De Cobelli, O., Rocco, B., De Nunzio, C., Tubaro, A., Coman, I., Feciche, B., Truss, M., Dalpiaz, O., Figenshau, R. S., Madison, K., Sánchez-Chapado, M., Santiago Martin, M. D. C., ... Brookman-May, S. (2016). Do we need new high-risk criteria for surgically treated renal cancer patients to improve the outcome of future clinical trials in the adjuvant setting? Results of a comprehensive analysis based on the multicenter CORONA database. European Journal of Surgical Oncology, 42(5), 744-750. https://doi.org/10.1016/j.ejso.2016.01.009