Feasibility and effectiveness of trifluridine/tipiracil in metastatic colorectal cancer: real-life data from The Netherlands |
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| Authors: | Johannes J. M. Kwakman G. Vink J. H. Vestjens L. V. Beerepoot J. W. de Groot R. L. Jansen F. L. Opdam H. Boot G. J. Creemers J. M. van Rooijen M. Los A. J. E. Vulink H. Schut E. van Meerten A. Baars P. Hamberg E. Kapiteijn D. W. Sommeijer C. J. A. Punt M. Koopman |
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| Affiliation: | 1.Department of Medical Oncology,Academic Medical Center, University of Amsterdam,Amsterdam,The Netherlands;2.Netherlands Comprehensive Cancer Organisation (IKNL),Utrecht,The Netherlands;3.Department of Internal Medicine,Viecuri Hospital,Venlo,The Netherlands;4.Department of Medical Oncology,Elisabeth-TweeSteden Hospital,Tilburg,The Netherlands;5.Department of Medical Oncology,Isala Clinics,Zwolle,The Netherlands;6.Department of Medical Oncology,Maastricht University Medical Center,Maastricht,The Netherlands;7.Department of Medical Oncology,The Netherlands Cancer Institute,Amsterdam,The Netherlands;8.Department of Gastroenterology and Hepatology,The Netherlands Cancer Institute,Amsterdam,The Netherlands;9.Department of Medical Oncology,Catharina Hospital,Eindhoven,The Netherlands;10.Department of Medical Oncology,Martini Hospital,Groningen,The Netherlands;11.Department of Medical Oncology,St. Antonius Hospital,Nieuwegein,The Netherlands;12.Department of Medical Oncology,Reinier de Graaf Gasthuis,Delft,The Netherlands;13.Department of Medical Oncology,Jeroen Bosch Hospital,Den Bosch,The Netherlands;14.Department of Medical Oncology,Erasmus Medical Center, Erasmus University,Rotterdam,The Netherlands;15.Department of Medical Oncology,Hospital Gelderse Vallei Ede,Ede,The Netherlands;16.Department of Medical Oncology,Franciscus Gasthuis,Rotterdam,The Netherlands;17.Department of Medical Oncology,Leiden University Medical Center,Leiden,The Netherlands;18.Department of Medical Oncology,Flevo Hospital,Almere,The Netherlands;19.Department of Medical Oncology,University Medical Center Utrecht,Utrecht,The Netherlands;20.Academic Medical Center, University of Amsterdam,Amsterdam,The Netherlands |
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| Abstract: | BackgroundThe RECOURSE trial showed clinical efficacy for trifluridine/tipiracil for refractory metastatic colorectal cancer patients. We assessed the feasibility and effectiveness of trifluridine/tipiracil in daily clinical practice in The Netherlands.MethodsMedical records of patients from 17 centers treated in the trifluridine/tipiracil compassionate use program were reviewed and checked for RECOURSE eligibility criteria. Baseline characteristics, safety, and survival times were compared, and prespecified baseline characteristics were tested in multivariate analyses for prognostic significance on overall survival (OS).ResultsA total of 136 patients with a median age of 62 years were analyzed. Forty-three patients (32%) did not meet the RECOURSE eligibility criteria for not having received all prior standard treatments (n = 35, 26%) and/or ECOG performance status (PS) 2 (n = 12, 9%). The most common grade ≥3 toxicities were neutropenia (n = 44, 32%), leukopenia (n = 8, 6%), anemia (n = 7, 5%), and fatigue (n = 7, 5%). Median progression-free survival (PFS) and median OS were 2.1 (95% CI, 1.8–2.3) and 5.4 months (95% CI, 4.0–6.9), respectively. Patients with ECOG PS 2 had a worse median OS (3.2 months) compared to patients with ECOG PS 0–1 (5.9 months). ECOG PS, KRAS-mutation status, white blood cell count, serum lactate dehydrogenase, and alkaline phosphatase were prognostic factors for OS.ConclusionsOur data show that treatment with trifluridine/tipiracil in daily clinical practice is feasible and safe. Differences in patient characteristics between our population and the RECOURSE study population should be taken into account in the interpretation of survival data. Our results argue against the use of trifluridine/tipiracil in patients with ECOG PS 2.FundingJohannes J.M. Kwakman received an unrestricted research grant from Servier. |
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