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ESMO Open. 2017 Nov 23;2(5):e000261. doi: 10.1136/esmoopen-2017-000261. eCollection 2017.

Proxies of quality of life in metastatic colorectal cancer: analyses in the RECOURSE trial.

Author information

1
Department of Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium.
2
Department of Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
3
Department of Medical Oncology, Hospital Universitario 12 de Octubre/i+12, CNIO, CIBERONC, Universidad Complutense de Madrid, Spain.
4
Department of Cancer Center, Hokkaido University Hospital, Sapporo, Japan.
5
Department of Oncology, IRCCS AOU San Martino IST, Genoa, Italy.
6
Department of Oncology, Antwerp University Hospital, Edegem, Belgium.
7
Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
8
Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
9
Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.
10
Department of Oncologia Medica, Fondazione Poliambulanza, Brescia, Italy.
11
Department of PIT Oncology, Institut de Recherches Servier, Suresnes, Île-de-France, France.
12
Taiho Oncology, Princeton, New Jersey, USA.
13
Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
14
Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.

Abstract

Background:

In the pivotal phase III, randomised, double-blind, placebo-controlled RECOURSE study, treatment with trifluridine/tipiracil was well tolerated and associated with prolonged progression-free and overall survival in patients with metastatic colorectal cancer (mCRC). There was no formal analysis of quality of life (QoL) in RECOURSE. The aim of the present analysis was to assess proxies of QoL during the RECOURSE treatment period, in terms of adverse events (AEs) likely to affect QoL and Eastern Cooperative Oncology Group performance status (ECOG PS).

Patients and methods:

Enrolled patients had documented, previously treated (≥2 prior chemotherapy lines) mCRC and an ECOG PS of 0 or 1. Patients received best supportive care plus trifluridine/tipiracil 35 mg/m2 twice daily (n=534) or placebo (n=266) in a 28-day cycle. AEs analysed included nausea, vomiting, diarrhoea, dysgeusia and fatigue/asthenia. ECOG PS was determined at baseline, on day 1 of each treatment cycle, at treatment end and 30 days post-treatment discontinuation.

Results:

AEs that affect QoL were more frequent in patients treated with trifluridine/tipiracil than placebo. Median treatment duration for patients experiencing at least one of these AEs was longer than that observed for the overall RECOURSE population (trifluridine/tipiracil: 12 vs 7 weeks; placebo: 10 vs 6 weeks). Versus placebo, the duration of most AEs was longer in trifluridine/tipiracil recipients; however, all AEs except nausea and vomiting occupied a lower proportion of the total treatment period. Of the patients who had their PS recorded at discontinuation, PS was maintained in 67% and 63% of trifluridine/tipiracil and placebo recipients, and 84% and 81% of the trifluridine/tipiracil and placebo patients remained at a PS of 0 or 1 at discontinuation.

Conclusions:

Analysis of ECOG PS and AEs thought to affect QoL in the RECOURSE patient population suggests that trifluridine/tipiracil treatment does not result in a deterioration of patient QoL versus placebo.

KEYWORDS:

advanced colorectal cancer; performance status; quality of life; trifluridine/tipiracil

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