Abstract
Introduction
Trifluridine/tipiracil combination has shown a benefit over placebo in the treatment of patients with chemorefractory metastatic colorectal cancer (mCRC). We evaluated the efficacy and safety of this combination in the real-life setting at eight Galician centers in Spain.
Patients and methods
This is a retrospective study of a cohort of patients with mCRC in treatment with trifluridine/tipiracil within usual clinical practice who have been previously treated or are not considered candidates for treatment with available therapies.
Results
A total of 160 mCRC patients were included. Our data showed that 11.9% of patients achieved disease control. Median progression-free survival was 2.75 months; at 5.66 months follow-up, median overall survival was 7.94 months. Asthenia and neutropenia (48.1% both) were the most frequent adverse events. Overall survival was lower in patients with ECOG 2, multiple metastatic sites, platelets count 350,000/µl, alkaline phosphatase > 500 IU/l, and carcinoembryonic antigen > 10 ng/ml.
Conclusion
The results of this study confirm the efficacy and safety of trifluridine/tipiracil in chemorefractory mCRC patients. However, patients in clinical practice differ from patients in clinical trials. Due to this, prognostic factors have special importance to offer the best therapeutic approach.
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Acknowledgements
The authors wish to thank Dr. Fernando Sánchez-Barbero and Springer Healthcare for his help in the preparation of the manuscript. Medical writing assistance was funded by Servier.
Funding
The study did not receive any grant from any funding agency in the public, commercial or not-for-profit sectors.
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Design: Ana Fernández Montes, Nieves Martínez Lago, Antía Cousillas Castiñeiras. Enrolled patients: all. Performed analyses: Ana Fernández Montes. Preparation of the manuscript: Francisca Vázquez, Ana Fernández Montes, and Nieves Martínez Lago.
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Conflicts of interest
AFM has been consultant for Sanofi, Celgene, Roche, Amgen, Servier, Bristol-Myers Squibb, and Lilly. PGV has been consultant for Amgen, and Lilly. The other authors declare that they have no competing interest.
Ethical approval
The study was approved by the Galician Regional Research Ethics Committee (Reference Number 2018/230) and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.
Informed consent
Informed consent was obtained from all individual participants included in the study. Eligible patients should give their consent to participate in the study and to allow their medical records to be reviewed after having been informed and having had sufficient time to decide on their inclusion in the study. Each center's ethics committee was asked to waive the signing of informed consent for those patients who had died at the start of the study.
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Fernandez Montes, A., Vazquez Rivera, F., Martinez Lago, N. et al. Efficacy and safety of trifluridine/tipiracil in third-line and beyond for the treatment of patients with metastatic colorectal cancer in routine clinical practice: patterns of use and prognostic nomogram. Clin Transl Oncol 22, 351–359 (2020). https://doi.org/10.1007/s12094-019-02130-x
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DOI: https://doi.org/10.1007/s12094-019-02130-x