Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study

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dc.authoridWyrwicz, Lucjan/0000-0003-0808-6892
dc.authoridCREMOLINI, CHIARA/0000-0002-0520-4841
dc.authoridFalcone, Alfredo/0000-0001-5840-2529
dc.authoridtaieb, julien/0000-0002-9955-4753
dc.authoridBecquart, Martin/0000-0002-3102-8423
dc.authorwosidCremolini, Chiara/AAC-1889-2019
dc.authorwosidVan+Cutsem, Eric/ABE-1762-2021
dc.authorwosidBACHET, Jean-Baptiste/N-6943-2017
dc.authorwosidÖzet, ahmet/ABC-9831-2021
dc.authorwosidFalcone, Alfredo/G-5217-2013
dc.authorwosidPrice, Timothy J/G-1404-2012
dc.authorwosidWyrwicz, Lucjan/ABD-6558-2021
dc.contributor.authorBachet, Jean-Baptiste
dc.contributor.authorWyrwicz, Lucjan
dc.contributor.authorPrice, Timothy
dc.contributor.authorCremolini, Chiara
dc.contributor.authorPhelip, Jean-Marc
dc.contributor.authorPortales, Fabienne
dc.contributor.authorOzet, Ahmet
dc.date.accessioned2024-06-12T10:58:07Z
dc.date.available2024-06-12T10:58:07Z
dc.date.issued2020
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBackground In RECOURSE (, trifluridine/tipiracil significantly improved overall survival and progression-free survival (PFS) versus placebo in patients with pretreated metastatic colorectal cancer (mCRC). PRECONNECT was designed to further characterise safety and clinical use of trifluridine/tipiracil. Methods In this ongoing, international, multicentre, open-label trial, patients with pretreated mCRC received oral trifluridine/tipiracil 35 mg/m(2) twice daily on days 1-5 and 8-12 of each 28-day cycle. The primary endpoint was safety; secondary endpoints included PFS and quality of life (QoL). Results 793 patients (median age 62 years) from 13 countries received trifluridine/tipiracil for a median of 2.84 months (IQR 2.64). Adverse events (AEs) were experienced by 96.7%; the most common (>= 20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea. Grade >= 3 AEs occurred in 73.9% of patients, with the most common being neutropaenia (39.1% of patients), anaemia (9.8%) and asthenia/fatigue (5.0%). Median PFS was 2.8 months (95% CI 2.7 to 2.9). Median time to Eastern Cooperative Oncology Group performance status deterioration (>= 2) was 8.9 months (range 0.03-14.72). There was no clinically relevant change from baseline in QoL. Conclusions PRECONNECT showed consistent results with the previously demonstrated safety and efficacy profile of trifluridine/tipiracil, with no new safety concerns identified. QoL was maintained during treatment.en_US
dc.description.sponsorshipInstitut de Recherches Internationales Servier, Franceen_US
dc.description.sponsorshipThe PRECONNECT study was sponsored by Institut de Recherches Internationales Servier, France.en_US
dc.identifier.doi10.1136/esmoopen-2020-000698
dc.identifier.issn2059-7029
dc.identifier.issue3en_US
dc.identifier.pmid32487542en_US
dc.identifier.scopus2-s2.0-85085909242en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://doi.org/10.1136/esmoopen-2020-000698
dc.identifier.urihttps://hdl.handle.net/20.500.14551/19952
dc.identifier.volume5en_US
dc.identifier.wosWOS:000573855000002en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.ispartofEsmo Openen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectColorectal Canceren_US
dc.subjectMetastaticen_US
dc.subjectQuality Of Lifeen_US
dc.subjectSafetyen_US
dc.subjectTrifluridine Tipiracilen_US
dc.subjectTas-102 Monotherapyen_US
dc.subjectCost-Effectivenessen_US
dc.subjectDouble-Blinden_US
dc.subjectPlaceboen_US
dc.subjectRegorafeniben_US
dc.subjectTrialen_US
dc.titleSafety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT studyen_US
dc.typeArticleen_US

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