Garcia-Alfonso, PilarMuñoz, AndresJimenez-Castro, JeronimoJimenez-Fonseca, PaulaPericay, CarlesLongo-Muñoz, FedericoReyna-Fortes, CarmenArgiles-Martinez, GuillemGonzalez-Astorga, BeatrizGomez-Reina, Maria JoseRuiz-Casado, AnaRodriguez-Salas, NuriaLopez-Lopez, RafaelCarmona-Bayonas, AlbertoConde-Herrero, VeronicaAranda, Enrique2022-08-232022-08-232021-09-08García-Alfonso P, Muñoz A, Jiménez-Castro J, Jiménez-Fonseca P, Pericay C, Longo-Muñoz F, et al. Early Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study. Cancers. 2021 Sep 8;13(18):4514http://hdl.handle.net/10668/3928Trifluridine/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.enAtribución 4.0 Internacionalhttp://creativecommons.org/licenses/by/4.0/BiomarkersChemotherapyColorectal cancerCombination therapyReal-lifeTrifluridine/tipiracilMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidine Nucleosides::Thymidine::TrifluridineMedical Subject Headings::Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Hydrolases::Esterases::Phosphoric Monoester Hydrolases::Alkaline PhosphataseMedical Subject Headings::Anatomy::Cells::Blood Cells::Leukocytes::Granulocytes::NeutrophilsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies::Retrospective StudiesMedical Subject Headings::Geographical Locations::Geographic Locations::Europe::SpainMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Anthropometry::Body Weights and Measures::Tumor BurdenMedical Subject Headings::Diseases::Digestive System Diseases::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal NeoplasmsMedical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::NeutropeniaMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment OutcomeMedical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Disease ProgressionMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Regression AnalysisMedical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Blood Platelet Disorders::ThrombocytopeniaMedical Subject Headings::Diseases::Neoplasms::Neoplasms by Site::Digestive System NeoplasmsMedical Subject Headings::Anatomy::Cells::Blood Cells::Leukocytes::Leukocytes, Mononuclear::LymphocytesMedical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Anemiaresearch article34572740open accessBiomarcadoresQuimioterapiaNeoplasias colorrectalesQuimioterapia combinadaTrifluridina10.3390/cancers131845142072-6694PMC8468101