PMID- 29211817
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  - QTWiST analysis of the RECOURSE trial of trifluridine/tipiracil in metastatic 
      colorectal cancer.
PG  - e000284
LID - 10.1136/esmoopen-2017-000284 [doi]
LID - e000284
AB  - PURPOSE: A Quality-adjusted Time WIthout Symptoms of disease or Toxicity (QTWiST) 
      analysis was carried out to assess quality-adjusted survival time in the RECOURSE 
      trial of trifluridine/tipiracil versus placebo in pretreated metastatic 
      colorectal cancer (mCRC). METHODS: Duration of overall survival in the RECOURSE 
      trial (n=798 patients) was partitioned into three discrete health states: 
      toxicity (TOX), time without symptoms or toxicity (TWIST) and relapse (REL). TOX 
      was defined as time spent with grade 3 or 4 treatment-related adverse events 
      (AEs) after randomisation and before progression or censoring. AEs were limited 
      to those related to trifluridine/tipiracil and known to affect quality of life 
      (QoL) (ie, nausea, vomiting, diarrhoea, fatigue/asthaenia, anorexia and febrile 
      neutropaenia). The estimated mean duration of each state, weighted by a utility 
      coefficient representing QoL, was combined into a global QTWiST score. RESULTS: 
      In the RECOURSE trial, overall survival was 7.1 months with 
      trifluridine/tipiracil versus 5.3 months with placebo. Patients receiving 
      trifluridine/tipiracil spent longer in each health state than placebo recipients. 
      Using assumed utility coefficients of 1 for TWIST and 0.5 for TOX and REL, the 
      QTWiST was 5.48 months for the trifluridine/tipiracil group and 3.98 months for 
      the placebo group, a difference of 1.5 (95% CI 1.49 to 1.52) months in favour of 
      trifluridine/tipiracil. A sensitivity analysis using large variations in utility 
      coefficients for TOX and REL produced a range of only approximately 0.5 months 
      from minimum to maximum QTWiST. CONCLUSIONS: Quality-adjusted survival, as 
      measured by QTWiST, shows clinically meaningful improvements in patients treated 
      with trifluridine/tipiracil versus placebo in pretreated mCRC.
FAU - Tabernero, Josep
AU  - Tabernero J
AD  - Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, 
      Barcelona, Spain.
FAU - Van Cutsem, Eric
AU  - Van Cutsem E
AD  - University Hospitals Leuven, Leuven, Belgium.
FAU - Ohtsu, Atsushi
AU  - Ohtsu A
AD  - National Cancer Center Hospital East, Kashiwa, Japan.
FAU - Amellal, Nadia
AU  - Amellal N
AD  - Institut de Recherches Internationales Servier, Suresnes, France.
FAU - Cadour, Stephanie
AU  - Cadour S
AD  - Institut de Recherches Internationales Servier, Suresnes, France.
FAU - Fougeray, Ronan
AU  - Fougeray R
AD  - Institut de Recherches Internationales Servier, Suresnes, France.
FAU - Haffemayer, Benjamin
AU  - Haffemayer B
AD  - Market Access Department, Servier, Suresnes, France.
FAU - Mayer, Robert J
AU  - Mayer RJ
AD  - Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
LA  - eng
PT  - Journal Article
DEP - 20171123
PL  - England
TA  - ESMO Open
JT  - ESMO open
JID - 101690685
CIN - ESMO Open. 2017 Nov 23;2(5):e000261. PMID: 29215098
PMC - PMC5708318
OTO - NOTNLM
OT  - QTWIST
OT  - metastatic colorectal cancer
OT  - quality of life
OT  - trifluridine/tipiracil
COIS- Competing interests: JT reports consulting/advisory fees from Amgen, Boehringer 
      Ingelheim, Celgene, Chugai, Imclone Systems Inc., Eli Lilly and Company, Merck & 
      Co., Merck Serono, Millennium, Novartis, F. Hoffmann-La Roche Ltd., Sanofi, 
      Symphogen and Taiho Oncology Inc. EVC has received research funding from Amgen, 
      Bayer, Boehringer, Celgene, Ipsen, Lilly, Merck, Merck KgA, Novartis, Roche, 
      Sanofi and Servier. RJM has performed a consulting/advisory role for Taiho. AO 
      has an immediate family member who is an employee of Celgene. NA, SC, RF and BH 
      are employees of Servier.
EDAT- 2017/12/07 06:00
MHDA- 2017/12/07 06:01
PMCR- 2017/11/23
CRDT- 2017/12/07 06:00
PHST- 2017/10/05 00:00 [received]
PHST- 2017/10/10 00:00 [revised]
PHST- 2017/10/16 00:00 [accepted]
PHST- 2017/12/07 06:00 [entrez]
PHST- 2017/12/07 06:00 [pubmed]
PHST- 2017/12/07 06:01 [medline]
PHST- 2017/11/23 00:00 [pmc-release]
AID - S2059-7029(20)32391-7 [pii]
AID - esmoopen-2017-000284 [pii]
AID - 10.1136/esmoopen-2017-000284 [doi]
PST - epublish
SO  - ESMO Open. 2017 Nov 23;2(5):e000284. doi: 10.1136/esmoopen-2017-000284. 
      eCollection 2017.