PMID- 29215098 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220311 IS - 2059-7029 (Print) IS - 2059-7029 (Electronic) IS - 2059-7029 (Linking) VI - 2 IP - 5 DP - 2017 TI - Proxies of quality of life in metastatic colorectal cancer: analyses in the RECOURSE trial. PG - e000261 LID - 10.1136/esmoopen-2017-000261 [doi] LID - e000261 AB - 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/m(2) 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. FAU - Van Cutsem, Eric AU - Van Cutsem E AD - Department of Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium. FAU - Falcone, Alfredo AU - Falcone A AD - Department of Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. FAU - Garcia-Carbonero, Rocio AU - Garcia-Carbonero R AD - Department of Medical Oncology, Hospital Universitario 12 de Octubre/i+12, CNIO, CIBERONC, Universidad Complutense de Madrid, Spain. FAU - Komatsu, Yoshito AU - Komatsu Y AD - Department of Cancer Center, Hokkaido University Hospital, Sapporo, Japan. FAU - Pastorino, Alessandro AU - Pastorino A AD - Department of Oncology, IRCCS AOU San Martino IST, Genoa, Italy. FAU - Peeters, Marc AU - Peeters M AD - Department of Oncology, Antwerp University Hospital, Edegem, Belgium. FAU - Shimada, Yasuhiro AU - Shimada Y AD - Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan. FAU - Yamazaki, Kentaro AU - Yamazaki K AD - Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan. FAU - Yoshino, Takayuki AU - Yoshino T AD - Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan. FAU - Zaniboni, Alberto AU - Zaniboni A AD - Department of Oncologia Medica, Fondazione Poliambulanza, Brescia, Italy. FAU - Amellal, Nadia AU - Amellal N AD - Department of PIT Oncology, Institut de Recherches Servier, Suresnes, Ile-de-France, France. FAU - Kanehisa, Akira AU - Kanehisa A AD - Department of PIT Oncology, Institut de Recherches Servier, Suresnes, Ile-de-France, France. FAU - Winkler, Robert AU - Winkler R AD - Taiho Oncology, Princeton, New Jersey, USA. FAU - Makris, Lukas AU - Makris L AD - Taiho Oncology, Princeton, New Jersey, USA. FAU - Mayer, Robert J AU - Mayer RJ AD - Dana-Farber Cancer Institute, Boston, Massachusetts, USA. FAU - Ohtsu, Atsushi AU - Ohtsu A AD - Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan. FAU - Tabernero, Josep AU - Tabernero J AD - Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autonoma de Barcelona, Barcelona, Spain. LA - eng PT - Comment PT - Journal Article DEP - 20171123 PL - England TA - ESMO Open JT - ESMO open JID - 101690685 CON - ESMO Open. 2017 Nov 23;2(5):e000284. PMID: 29211817 PMC - PMC5708320 OTO - NOTNLM OT - advanced colorectal cancer OT - performance status OT - quality of life OT - trifluridine/tipiracil COIS- Competing interests: None declared. EDAT- 2017/12/08 06:00 MHDA- 2017/12/08 06:01 PMCR- 2017/11/23 CRDT- 2017/12/08 06:00 PHST- 2017/08/18 00:00 [received] PHST- 2017/09/13 00:00 [revised] PHST- 2017/09/15 00:00 [accepted] PHST- 2017/12/08 06:00 [entrez] PHST- 2017/12/08 06:00 [pubmed] PHST- 2017/12/08 06:01 [medline] PHST- 2017/11/23 00:00 [pmc-release] AID - S2059-7029(20)32387-5 [pii] AID - esmoopen-2017-000261 [pii] AID - 10.1136/esmoopen-2017-000261 [doi] PST - epublish SO - ESMO Open. 2017 Nov 23;2(5):e000261. doi: 10.1136/esmoopen-2017-000261. eCollection 2017.