515P - RECOURSE trial: Performance status at discontinuation in patients receiving trifluridine/tipiracil (TAS-102)

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Eric Van Cutsem
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors E. Van Cutsem1, R. Garcia-Carbonero2, A. Pastorino3, A. Zaniboni4, A. Falcone5, N. Amellal6, F. Benedetti7, R. Mayer8, A. Ohtsu9, J. Tabernero10
  • 1Digestive Oncology, University Hospitals Leuven - Campus Gasthuisberg, 3000 - Leuven/BE
  • 2Oncology, University Hospital 12 De Octubre, Madrid/ES
  • 3Department Of Medical Oncology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 1632 - Genova/IT
  • 4Oncology, Fondazione Poliambulanza, Brescia/IT
  • 5Dept. Of Oncology-presidio Ospedaliero, Azienda Ospedaliera Universitaria S.Chiara, 56100 - Pisa/IT
  • 692284, Institut de Recherches Internationales SERVIER (I.R.I.S.), SURESNES/FR
  • 7Oncology, Taiho, Tokyo/JP
  • 8Gastrointestinal Cancer, Dana-Farber Cancer Institute, Boston/US
  • 9Department Of Gastroenterology And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 10Oncologia Médica, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES

Abstract

Background

The efficacy and safety of trifluridine/tipiracil (TAS-102) has been explored in patients with metastatic colorectal cancer (mCRC) refractory who were intolerant to standard therapies in the phase 3 RECOURSE trial. Treatment with trifluridine/tipiracil was associated with significantly improved overall and progression-free survival versus placebo. In a post hoc analysis, we compared the level of performance status (PS) at treatment discontinuation in the two arms.

Methods

PS was evaluated in RECOURSE using the Eastern Cooperative Oncology Group (ECOG) score. Patients included in this trial had PS = 0 or 1 at baseline. The PS at treatment discontinuation with ECOG scores 0 to 4 was compared to PS at baseline on treatment and placebo (descriptive statistics).

Results

A total of 759 patients (95% of the RECOURSE population) had information on PS at treatment discontinuation. Of these, 424 (53%) had PS = 0 and 335 (42%) had PS = 1. Of the 496 trifluridine/tipiracil patients who discontinued treatment, 340 (69%) maintained the same level of PS, and only 78 (16%) had PS ≥ 2 at discontinuation (Table). Similar values were found in placebo patients, with 170/263 (65%) maintaining their PS and 50/263 (19%) with PS ≥ 2 at discontinuation.

Baseline PS
Trifluridine/tipiracil Placebo
0 (n = 278) 1 (n = 218) 0 (n = 146) 1 (n = 117)
PS at discontinuation
0 180 (65%) 8 (4%) 86 (60%) 4 (3%)
1 78 (28%) 152 (70%) 43 (30%) 80 (68%)
2 13 (5%) 40 (18%) 13 (9%) 22 (19%)
3 6 (2%) 17 (8%) 4 (3%) 8 (7%)
4 1 (0.4%) 1 (0.5%) 0 3 (3%)

Conclusions

Our results indicate that, despite expected treatment-related adverse events, the level of PS at treatment progression was maintained in patients treated with trifluridine/tipiracil.

Clinical trial identification

Legal entity responsible for the study

Taiho and Institut de Recherches Internationales Servier

Funding

Taiho and Institut de Recherches Internationales Servier

Disclosure

All authors have declared no conflicts of interest.