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Early Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study

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dc.contributor.authorGarcía-Alfonso, Pilar
dc.contributor.authorMuñoz, Andrés
dc.contributor.authorJiménez-Castro, Jerónimo
dc.contributor.authorJiménez-Fonseca, Paula
dc.contributor.authorPericay, Carles
dc.contributor.authorLongo-Muñoz, Federico
dc.contributor.authorReyna-Fortes, Carmen
dc.contributor.authorArgilés-Martínez, Guillem
dc.contributor.authorGonzález-Astorga, Beatriz
dc.contributor.authorGómez-Reina, María José
dc.contributor.authorRuiz-Casado, Ana
dc.contributor.authorRodríguez-Salas, Nuria
dc.contributor.authorLópez-López, Rafael
dc.contributor.authorCarmona-Bayonas, Alberto
dc.contributor.authorConde-Herrero, Verónica
dc.contributor.authorAranda, Enrique
dc.contributor.authoraffiliation[García-Alfonso,P; Muñoz,A] Department of Medical Oncology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Jiménez-Castro,J] Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain. [Jiménez-Fonseca,P] Department of Medical Oncology, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain. [Pericay,C] Department of Medical Oncology, Hospital Universitari Parc Taulí, Sabadell, Spain. [Longo-Muñoz,F] Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Reyna-Fortes,C] Department of Medical Oncology, UGC Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain. [Argilés-Martínez,G] Department of Medical Oncology, Hospital Universitari Vall d’Hebrón, Barcelona, Spain. [González-Astorga,B] Department of Medical Oncology, Hospital Universitario Clínico San Cecilio, Granada, Spain. [Gómez-Reina,MJ] Department of Medical Oncology, Hospital Universitario Puerta del Mar, Cádiz, Spain. [Ruiz-Casado,A] Department of Medical Oncology, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain. [Rodríguez-Salas,N] Department of Medical Oncology, Hospital Universitario La Paz, CIBERONC, Madrid, Spain. [López-López,R] Translational Medical Oncology Group, Department of Medical Oncology, Hospital Clínico Universitario e Instituto de Investigación Sanitaria (IDIS), CIBERONC, Facultad de Medicina de la Universidad de Santiago de Compostela, Santiago de Compostela, Spain. [Carmona-Bayonas,A] Department of Medical Oncology, Hospital General Universitario Morales Meseguer, Murcia, Spain. [Conde-Herrero,V] Department of Medical Oncology, Hospital Universitario Virgen de las Nieves, Granada, Spain. [Aranda,E] Department of Medical Oncology, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, CIBERONC, Instituto de Salud Carlos III, Córdoba, Spain.
dc.date.accessioned2024-02-19T15:30:56Z
dc.date.available2024-02-19T15:30:56Z
dc.date.issued2021-09-08
dc.description.abstractTrifluridine/tipiracil is currently approved for metastatic colorectal cancer (mCRC) refractory to available therapies. However, there is no consensus on factors that predict treatment outcomes in daily practice. We assessed the early clinical experience with trifluridine/tipiracil in Spain and potential survival markers. This was a retrospective cohort study of mCRC patients who participated in the trifluridine/tipiracil early clinical experience programme in Spain. The primary outcome was overall survival (OS). Associations between OS and patient characteristics were assessed using multivariate Cox regression analyses. A total of 379 patients were included in the study. Trifluridine/tipiracil was administered for a median of 3.0 cycles and discontinued mainly due to disease progression (79.2%). The median OS was 7.9 months, with a 12-month OS rate of 30.5%. Cox analyses revealed that the following variables independently enhanced OS: ≤2 metastatic sites, no liver metastasis, alkaline phosphatase < 300 IU, trifluridine/tipiracil dose reductions, and neutrophil/lymphocyte ratio < 5. Grade ≥ 3 toxicities were reported in 141 (37.2%) patients, including mainly afebrile neutropaenia (23.2%), anaemia (12.1%), and thrombocytopaenia (5.3%). This study supports the real-life efficacy and safety of trifluridine/tipiracil for refractory mCRC and identifies tumour burden, liver metastasis, alkaline phosphatase, dose reductions, and neutrophil/lymphocyte ratio as survival markers.
dc.description.sponsorshipThis work was supported by the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) through a grant provided by Laboratorios Servier S.L. (grant reference number: not applicable)
dc.identifier.doi10.3390/cancers13184514
dc.identifier.e-issn2072-6694es_ES
dc.identifier.journalCancerses_ES
dc.identifier.otherhttp://hdl.handle.net/10668/3928
dc.identifier.pubmedID34572740es_ES
dc.identifier.urihttp://hdl.handle.net/20.500.12105/18457
dc.language.isoeng
dc.publisherMultidisciplinary Digital Publishing Institute (MDPI)
dc.relation.publisherversionhttps://www.mdpi.com/2072-6694/13/18/4514/htmes
dc.rights.accessRightsopen accesses_ES
dc.rights.licenseAttribution 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectBiomarkers
dc.subjectChemotherapy
dc.subjectColorectal cancer
dc.subjectCombination therapy
dc.subjectReal-life
dc.subjectTrifluridine/tipiracil
dc.subjectBiomarcadores
dc.subjectQuimioterapia
dc.subjectNeoplasias colorrectales
dc.subjectQuimioterapia combinada
dc.subjectTrifluridina
dc.subject.meshHumans
dc.subject.meshTrifluridine
dc.subject.meshAlkaline Phosphatase
dc.subject.meshNeutrophils
dc.subject.meshRetrospective Studies
dc.subject.meshSpain
dc.subject.meshTumor Burden
dc.subject.meshColorectal Neoplasms
dc.subject.meshNeutropenia
dc.subject.meshTreatment Outcome
dc.subject.meshDisease Progression
dc.subject.meshRegression Analysis
dc.subject.meshThrombocytopenia
dc.subject.meshDigestive System Neoplasms
dc.subject.meshLymphocytes
dc.subject.meshAnemia
dc.titleEarly Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study
dc.typeresearch article
dc.type.hasVersionVoR
dspace.entity.typePublication
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IBIMA-Plataforma BIONAND - Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (Andalucía)
IDIS - Instituto de Investigación Sanitaria de Santiago de Compostela (Galicia)
IMIBIC - Instituto Maimónides de Investigación Biomédica de Córdoba (Andalucía)
ISPA - Instituto de Investigación Sanitaria del Principado de Asturias (Asturias)