dc.contributor
Institut Català de la Salut
dc.contributor
[Tabernero J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, Barcelona, Catalunya, Spain. Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Argiles G] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. UVic-UCC, IOB-Quiron, Barcelona, Catalunya, Spain. Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Sobrero AF] Medical Oncology Ospedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l'Oncologia. [Borg C] Department of Medical Oncology, University Hospital Centre Besançon, Besancon, Bourgogne Franche-Comté, France. [Ohtsu A] Kashiwa, National Cancer Center-Hospital East, Kashiwa, Chiba, Japan. [Mayer RJ] Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, USA
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Tabernero Caturla, Josep
dc.contributor.author
Argilés Martinez, Guillem
dc.contributor.author
Borg, Christophe
dc.contributor.author
Ohtsu, Atsushi
dc.contributor.author
Mayer, Robert
dc.contributor.author
Sobrero, Alberto
dc.date.issued
2021-09-20T13:10:54Z
dc.date.issued
2021-09-20T13:10:54Z
dc.date.issued
2020-08-19
dc.identifier
Tabernero J, Argiles G, Sobrero AF, Borg C, Ohtsu A, Mayer RJ, et al. Effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors at baseline: an exploratory analysis. ESMO Open. 2020 Aug 19;5:e000752.
dc.identifier
https://hdl.handle.net/11351/6334
dc.identifier
10.1136/esmoopen-2020-000752
dc.identifier
000564366600005
dc.description.abstract
Quimioteràpia; Metàstasis; Pronòstic
dc.description.abstract
Quimioterapia; Metástasis; Pronóstico
dc.description.abstract
Chemotherapy; Metastases; Prognosis
dc.description.abstract
Background
The choice of treatment in patients with metastatic colorectal cancer (mCRC) is generally influenced by tumour and patient characteristics, treatment efficacy and tolerability, and quality of life. Better patient selection might lead to improved outcomes.
Methods
This post hoc exploratory analysis examined the effect of prognostic factors on outcomes in the Randomized, Double-blind, Phase 3 Study of trifluridine tipiracil (FTD/TPI) plus Best Supportive Care (BSC) versus Placebo plus BSC in Patients with mCRC Refractory to Standard Chemotherapies (RECOURSE) trial. Patients were redivided by prognosis into two subgroups: those with <3 metastatic sites at randomisation (low tumour burden) and ≥18 months from diagnosis of metastatic disease to randomisation (indolent disease) were included in the good prognostic characteristics (GPC) subgroup; the remaining patients were considered to have poor prognostic characteristics (PPC).
Results
GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms. GPC patients receiving trifluridine/tipiracil (n=261) had an improved median overall survival (9.3 vs 5.3 months; HR (95% CI) 0.46 (0.37 to 0.57), p<0.0001) and progression-free survival (3.3 vs 1.9 months; HR (95% CI) 0.56 (0.46 to 0.67), p<0.0001) than PPC patients receiving trifluridine/tipiracil (n=273). Improvements in survival were irrespective of age, Eastern Cooperative Oncology Group Performance Status (ECOG PS), KRAS mutational status, and site of metastases at randomisation. In the trifluridine/tipiracil arm, time to deterioration of ECOG PS to ≥2 and proportion of patients with PS=0–1 discontinuing treatment were longer for GPC than for PPC patients (7.8 vs 4.2 months and 89.1% vs 78.4%, respectively).
Conclusion
Low tumour burden and indolent disease were factors of good prognosis in late-line mCRC, with patients experiencing longer progression-free survival and greater overall survival.
dc.description.abstract
The RECOURSE study was funded by Taiho Oncology and Taiho Pharmaceutical Co.; this analysis was funded by Servier in partnership with Taiho.
dc.format
application/pdf
dc.format
application/pdf
dc.relation
https://doi.org/10.1136/esmoopen-2020-000752
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Còlon - Càncer
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Recte - Càncer
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Quimioteràpia combinada
dc.subject
DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Clinical Protocols::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols
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Other subheadings::Other subheadings::/therapeutic use
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ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales
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TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::protocolos clínicos::protocolos antineoplásicos::protocolos de quimioterapia antineoplásica combinada
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Otros calificadores::Otros calificadores::/uso terapéutico
dc.title
Effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors at baseline: an exploratory analysis
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion