RECOURSE trial: impact of adverse events on quality of life and duration of TAS-102 (trifluridine and tipiracil) treatment

Date 29 June 2016
Event ESMO World Congress on Gastrointestinal Cancer 2016
Session ESMO World Congress on Gastrointestinal Cancer 2016 - Abstracts book
Presenter J. Tabernero
Citation Annals of Oncology (2016) 27 (2): 102-117. 10.1093/annonc/mdw200
Authors J. Tabernero1, J. Mayer Robert2, A. Ohtsu3, T. Yoshino3, R. Garcia-Carbonero4, A. Pastorino5, M. Peeters6, R. Winkler7, L. Makris8, M. Wahba7, A. Zaniboni9, Y. Shimada10, K. Yamazaki11, Y. Komatsu12, H. Hochster13, H.-. Lenz14, A. Falcone15, B. Tran16, E. Van Cutsem17
  • 1Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain, /
  • 2Dana-Farber Cancer Institute, Boston, Massachusetts, USA, /
  • 3National Cancer Center Hospital East, Kashiwa, Japan, /
  • 4Hospital Universitario 12 de Octubre, Madrid, Spain, /
  • 5IRCCS AOU San Martino IST, Genova, Italy, /
  • 6Antwerp University Hospital, Edegem, Belgium, /
  • 7Taiho Oncology Inc., Princeton, New Jersey, USA, /
  • 8Stathmi Inc., New Hope, Pennsylvania, USA, /
  • 9Fondazione Poliambulanza, Brescia, Italy, /
  • 10National Cancer Center Hospital, Chuo-ku, Japan, /
  • 11Shizuoka Cancer Center, Sunto-gun, Japan, /
  • 12Department of Cancer Center, Hokkaido University Hospital, Sapporo, Japan, /
  • 13Yale Cancer Center, New Haven, Connecticut, USA, /
  • 14USC Norris Comprehensive Cancer Center, Los Angeles, California, USA, /
  • 15Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy, /
  • 16The Royal Melbourne Hospital, Victoria, Australia, /
  • 17University Hospital Gasthuisberg, Leuven, Belgium, /

Abstract

TAS-102 is comprised of an antineoplastic nucleoside analog, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil. Efficacy and safety of TAS-102 in patients with metastatic colorectal cancer refractory/intolerant to standard therapies were evaluated in the Phase 3 RECOURSE trial. Results of RECOURSE demonstrated a significant improvement in overall and progression-free survival for TAS-102 vs placebo. The objective of this analysis was to compare the incidence and duration of selected adverse events (AEs), which were likely to affect quality of life (QoL) and study treatment duration, between the TAS-102 and placebo treatment groups.