Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS
dc.contributor.author | Tabernero, J | |
dc.contributor.author | Alsina, M | |
dc.contributor.author | Shitara, K | |
dc.contributor.author | Doi, T | |
dc.contributor.author | Dvorkin, M | |
dc.contributor.author | Mansoor, Was | |
dc.contributor.author | Arkenau, HT | |
dc.contributor.author | Prokharau, A | |
dc.contributor.author | Ghidini, M | |
dc.contributor.author | Faustino, C | |
dc.contributor.author | Gorbunova, V | |
dc.contributor.author | Zhavrid, E | |
dc.contributor.author | Nishikawa, K | |
dc.contributor.author | Ando, T | |
dc.contributor.author | Yalcin, S | |
dc.contributor.author | Van, CE | |
dc.contributor.author | Sabater, J | |
dc.contributor.author | Skanji, D | |
dc.contributor.author | Leger, C | |
dc.contributor.author | Amellal, N | |
dc.contributor.author | Ilson, DH | |
dc.date.accessioned | 2020-03-27T09:28:00Z | |
dc.date.available | 2020-03-27T09:28:00Z | |
dc.date.issued | 2020 | en |
dc.identifier.citation | Tabernero 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.pmid | 32128634 | en |
dc.identifier.doi | 10.1007/s10120-020-01053-9 | en |
dc.identifier.uri | http://hdl.handle.net/10541/622829 | |
dc.description.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. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1007/s10120-020-01053-9 | en |
dc.title | Health-related quality of life associated with trifluridine/tipiracil in heavily pretreated metastatic gastric cancer: results from TAGS | en |
dc.type | Article | en |
dc.contributor.department | Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain. | en |
dc.identifier.journal | Gastric Cancer | en |
dc.description.note | en] | |
refterms.dateFOA | 2020-03-30T13:48:12Z |