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dc.contributor.authorTabernero, J
dc.contributor.authorAlsina, M
dc.contributor.authorShitara, K
dc.contributor.authorDoi, T
dc.contributor.authorDvorkin, M
dc.contributor.authorMansoor, Was
dc.contributor.authorArkenau, HT
dc.contributor.authorProkharau, A
dc.contributor.authorGhidini, M
dc.contributor.authorFaustino, C
dc.contributor.authorGorbunova, V
dc.contributor.authorZhavrid, E
dc.contributor.authorNishikawa, K
dc.contributor.authorAndo, T
dc.contributor.authorYalcin, S
dc.contributor.authorVan, CE
dc.contributor.authorSabater, J
dc.contributor.authorSkanji, D
dc.contributor.authorLeger, C
dc.contributor.authorAmellal, N
dc.contributor.authorIlson, DH
dc.date.accessioned2020-03-27T09:28:00Z
dc.date.available2020-03-27T09:28:00Z
dc.date.issued2020en
dc.identifier.citationTabernero J, Alsina M, Shitara K, Doi T, Dvorkin M, Mansoor W, et al. Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS. Gastric Cancer. 2020.en
dc.identifier.pmid32128634en
dc.identifier.doi10.1007/s10120-020-01053-9en
dc.identifier.urihttp://hdl.handle.net/10541/622829
dc.description.abstractBACKGROUND: 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.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1007/s10120-020-01053-9en
dc.titleHealth-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGSen
dc.typeArticleen
dc.contributor.departmentVall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain.en
dc.identifier.journalGastric Canceren
dc.description.noteen]
refterms.dateFOA2020-03-30T13:48:12Z


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