Efficacy and safety of trifluridine/tipiracil in older and younger patients with metastatic gastric or gastroesophageal junction cancer: subgroup analysis of a randomized phase 3 study (TAGS)

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dc.authoridSantoro, Armando/0000-0003-1709-9492
dc.authoridBenhadji, Karim/0000-0001-9883-6970
dc.authorwosidSantoro, Armando/J-9594-2018
dc.authorwosidShitara, Kohei/AAA-3877-2021
dc.contributor.authorShitara, Kohei
dc.contributor.authorDoi, Toshihiko
dc.contributor.authorHosaka, Hisashi
dc.contributor.authorThuss-Patience, Peter
dc.contributor.authorSantoro, Armando
dc.contributor.authorLongo, Federico
dc.contributor.authorOzyilkan, Ozgur
dc.date.accessioned2024-06-12T11:15:39Z
dc.date.available2024-06-12T11:15:39Z
dc.date.issued2022
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBackground Trifluridine and tipiracil (FTD/TPI) demonstrated survival benefit vs placebo and manageable safety in previously treated patients with metastatic gastric/gastroesophageal junction cancer (mGC/GEJC) in the randomized, placebo-controlled, phase 3 TAGS study. This subgroup analysis of TAGS examined efficacy/safety outcomes by age. Methods In TAGS, patients with mGC/GEJC and >= 2 prior therapies were randomized (2:1) to receive FTD/TPI 35 mg/m(2) or placebo, plus best supportive care. A preplanned subgroup analysis was performed to evaluate efficacy and safety outcomes in patients aged < 65, >= 65, and >= 75 years. Results Among 507 randomized patients (n = 337 FTD/TPI; n = 170 placebo), 55%, 45%, and 14% were aged < 65, >= 65, and >= 75 years, respectively. Overall survival hazard ratios for FTD/TPI vs placebo were 0.67 (95% CI 0.51-0.89), 0.73 (95% CI 0.52-1.02), and 0.67 (95% CI 0.33-1.37) in patients aged < 65, >= 65, and >= 75 years, respectively. Regardless of age, patients receiving FTD/TPI experienced improved progression-free survival and stayed longer on treatment than those receiving placebo. Among FTD/TPI-treated patients, frequencies of any-cause grade >= 3 adverse events (AEs) were similar across age subgroups (80% each), although grade >= 3 neutropenia was more frequent in older patients [40% (>= 65 and >= 75 years); 29% (< 65 years)]; AE-related discontinuation rates did not increase with age [14% (< 65 years), 12% (>= 65 years), and 12% (>= 75 years)]. Conclusions The results of this subgroup analysis show the efficacy and tolerability of FTD/TPI treatment regardless of age in patients with mGC/GEJC who had received 2 or more prior treatments.en_US
dc.description.sponsorshipTaiho Oncology, Inc.; Taiho Pharmaceuticals Co., Ltd.en_US
dc.description.sponsorshipThis study was sponsored by Taiho Oncology, Inc., and Taiho Pharmaceuticals Co., Ltd. Professional medical writing and editorial assistance were provided by Vasupradha Vethantham, PhD, and Jennifer L. Robertson, PhD, at Ashfield MedComms, an Ashfield Health company, funded by Taiho Oncology, Inc.en_US
dc.identifier.doi10.1007/s10120-021-01271-9
dc.identifier.endpage597en_US
dc.identifier.issn1436-3291
dc.identifier.issn1436-3305
dc.identifier.issue3en_US
dc.identifier.pmid34997449en_US
dc.identifier.scopus2-s2.0-85122708367en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage586en_US
dc.identifier.urihttps://doi.org/10.1007/s10120-021-01271-9
dc.identifier.urihttps://hdl.handle.net/20.500.14551/24014
dc.identifier.volume25en_US
dc.identifier.wosWOS:000740186000001en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.relation.ispartofGastric Canceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectStomach Neoplasmsen_US
dc.subjectGastrointestinal Neoplasmsen_US
dc.subjectTrifluridine Tipiracilen_US
dc.subjectAge Groupsen_US
dc.subjectAgeden_US
dc.subjectRandomized Controlled Trialen_US
dc.subjectCombination Antimetaboliteen_US
dc.subjectChemotherapyen_US
dc.subjectTas-102en_US
dc.subjectPlaceboen_US
dc.subjectAgeen_US
dc.titleEfficacy and safety of trifluridine/tipiracil in older and younger patients with metastatic gastric or gastroesophageal junction cancer: subgroup analysis of a randomized phase 3 study (TAGS)en_US
dc.typeArticleen_US

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