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Repisalud author García-Alfonso, Pilar author Muñoz, Andrés author Jiménez-Castro, Jerónimo author Jiménez-Fonseca, Paula author Pericay, Carles author Longo-Muñoz, Federico author Reyna-Fortes, Carmen author Argilés-Martínez, Guillem author González-Astorga, Beatriz author Gómez-Reina, María José author Ruiz-Casado, Ana author Rodríguez-Salas, Nuria author López-López, Rafael author Carmona-Bayonas, Alberto author Conde-Herrero, Verónica author Aranda, Enrique 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. 2024-02-19T15:30:56Z 2024-02-19T15:30:56Z 2021-09-08 10.3390/cancers13184514 2072-6694 Cancers http://hdl.handle.net/10668/3928 34572740 http://hdl.handle.net/20.500.12105/18457 Trifluridine/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. eng Biomarkers Chemotherapy Colorectal cancer Combination therapy Real-life Trifluridine/tipiracil Biomarcadores Quimioterapia Neoplasias colorrectales Quimioterapia combinada Trifluridina Early Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study research article