Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: Results from TAGS Journal Article


Authors: Tabernero, J.; Alsina, M.; Shitara, K.; Doi, T.; Dvorkin, M.; Mansoor, W.; Arkenau, H. T.; Prokharau, A.; Ghidini, M.; Faustino, C.; Gorbunova, V.; Zhavrid, E.; Nishikawa, K.; Ando, T.; Yalçın, Ş; Van Cutsem, E.; Sabater, J.; Skanji, D.; Leger, C.; Amellal, N.; Ilson, D. H.
Article Title: Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: Results from TAGS
Abstract: Background: In TAGS, an international, double-blind, phase 3 trial, trifluridine/tipiracil significantly improved overall survival and progression-free survival compared with placebo in heavily pretreated metastatic gastric cancer patients. This paper reports pre-specified quality of life (QoL) outcomes for TAGS. Methods: Patients were randomized 2:1 to trifluridine/tipiracil (35 mg/m2 twice daily on days 1–5 and 8–12 of each 28-day cycle) plus best supportive care (BSC) or placebo plus BSC. QoL was evaluated at baseline and at each treatment cycle, using the EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaires; results were considered valid for analysis only if ≥ 10% of patients completed the questionnaires. Key QoL outcomes were mean changes from baseline and time to deterioration in QoL. A post hoc analysis assessed the association between QoL and time to deterioration of Eastern Cooperative Oncology Group performance score (ECOG PS) to ≥ 2. Results: Of 507 randomized patients, 496 had baseline QoL data available. The analysis cut-off was 6 cycles for trifluridine/tipiracil and 3 cycles for placebo. In both treatment groups, there were no clinically significant deteriorations in the mean QLQ-C30 Global Health Status (GHS) score, or in most subscale scores. In a sensitivity analysis including death and disease progression as events, there was a trend towards trifluridine/tipiracil reducing the risk of deterioration of QoL scores compared with placebo. Deterioration in the GHS score was associated with deterioration in ECOG PS. Conclusion: QoL was maintained in TAGS, and there was a trend towards trifluridine/tipiracil reducing the risk of QoL deterioration compared with placebo. Trial registration ClinicalTrials.gov number: NCT02500043 © 2020, The Author(s).
Keywords: controlled study; treatment outcome; major clinical study; constipation; fatigue; placebo; cancer growth; diarrhea; side effect; sensitivity analysis; multiple cycle treatment; pain; randomized controlled trial; cancer mortality; dyspnea; questionnaire; dysphagia; insomnia; scoring system; patient compliance; taste disorder; xerostomia; nausea and vomiting; stomach cancer; anxiety; phase 3 clinical trial; health-related quality of life; risk reduction; double blind procedure; body image; gastric cancer; hair loss; post hoc analysis; functional disease; phase 3; quality of life assessment; human; priority journal; article; loss of appetite; tipiracil plus trifluridine; trifluridine/tipiracil; european organization for research and treatment of cancer quality of life questionnaire core 30; global health status score; eastern cooperative oncology group performance score; european organization for research and treatment of cancer quality of life questionnaire gastric cancer module
Journal Title: Gastric Cancer
Volume: 23
Issue: 4
ISSN: 1436-3291
Publisher: Springer  
Date Published: 2020-07-01
Start Page: 689
End Page: 698
Language: English
DOI: 10.1007/s10120-020-01053-9
PUBMED: 32128634
PROVIDER: scopus
PMCID: PMC7305098
DOI/URL:
Notes: Article -- Export Date: 1 July 2020 -- Source: Scopus
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  1. David H Ilson
    334 Ilson