Analysis of patients ≥75 years in the open-label phase 3b CONSIGN trial of regorafenib in previously treated metastatic colorectal cancer (mCRC)

Date 29 June 2016
Event ESMO World Congress on Gastrointestinal Cancer 2016
Session ESMO World Congress on Gastrointestinal Cancer 2016 - Abstracts book
Presenter E. Van Cutsem
Citation Annals of Oncology (2016) 27 (2): 102-117. 10.1093/annonc/mdw200
Authors E. Van Cutsem1, F. Ciardiello2, M. Ychou3, J.-. Seitz4, R. Hofheinz5, Y. Arriaga6, R. Garcia-Carbonero7, A. Grothey8, A. Miriyala9, J. Kalmus9, C. Kappeler9, A. Falcone10, A. Zaniboni11
  • 1University Hospital Gasthuisberg, Leuven, Belgium, /
  • 2Second University of Naples, Naples, Italy, /
  • 3Institut Régional du Cancer de Montpellier (ICM), Montpellier, France, /
  • 4Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France, /
  • 5University Hospital Mannheim, Mannheim, Germany, /
  • 6University of Texas Southwestern Medical Center, Dallas, Texas, USA, /
  • 7Hospital Universitario 12 de Octubre, Madrid, Spain, /
  • 8Mayo Clinic, Rochester, New York, USA, /
  • 9Bayer Pharma AG, Berlin, Germany, /
  • 10Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, /
  • 11Fondazione Poliambulanza, Brescia, Italy, /


The highest rates of colorectal cancer occur in patients aged ≥65 years and the median age at diagnosis is 68 years. Older patients may not receive anticancer therapy because of concerns about tolerability. The multikinase inhibitor regorafenib improves survival vs placebo in patients with treatment-refractory mCRC. The large, single-arm, phase 3b CONSIGN trial (NCT01538680), which assigned 2872 patients with mCRC to treatment with regorafenib, showed that treatment-emergent adverse events (TEAEs) and progression-free survival (PFS) were consistent with results of phase 3 trials. We performed a subgroup analysis of CONSIGN to assess outcomes in patients ≥75 years of age.