1. Feasibility and effectiveness of trifluridine/tipiracil in metastatic colorectal cancer: real-life data from The Netherlands
- Author
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Kwakman, Johannes J.M., Vink, G., Vestjens, J. H., Beerepoot, L. V., de Groot, J. W., Jansen, R. L., Opdam, F. L., Boot, H., Creemers, G. J., van Rooijen, J. M., Los, M., Vulink, A. J.E., Schut, H., van Meerten, E., Baars, A., Hamberg, P., Kapiteijn, E., Sommeijer, D. W., Punt, C. J.A., Koopman, M., Sub Tolakker, Afd Pedagogiek in diverse samenlevingen, Methodology and statistics for the behavioural and social sciences, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Medische Oncologie (9), Interne Geneeskunde, Oncology, CCA - Cancer Treatment and Quality of Life, Sub Tolakker, Afd Pedagogiek in diverse samenlevingen, Methodology and statistics for the behavioural and social sciences, and Medical Oncology
- Subjects
Male ,0301 basic medicine ,THYMIDINE PHOSPHORYLASE ,PREDICTOR ,Pyrrolidines ,ANTITUMOR-ACTIVITY ,ECOG Performance Status ,Trifluridine ,chemistry.chemical_compound ,0302 clinical medicine ,QUALITY-OF-LIFE ,Antineoplastic Combined Chemotherapy Protocols ,Netherlands ,Aged, 80 and over ,education.field_of_study ,Metastatic colorectal cancer ,Trifluridine/tipiracil ,Feasibility ,Hematology ,General Medicine ,Middle Aged ,Prognosis ,TAS-102 ,Drug Combinations ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,SURVIVAL ,Population study ,Original Article ,Female ,TRIAL ,Colorectal Neoplasms ,medicine.drug ,Adult ,medicine.medical_specialty ,Anemia ,Population ,Neutropenia ,Disease-Free Survival ,03 medical and health sciences ,SDG 3 - Good Health and Well-being ,NEUTROPENIA ,Internal medicine ,PERFORMANCE STATUS ,medicine ,Humans ,Compassionate use ,Uracil ,education ,Aged ,Tipiracil ,Performance status ,business.industry ,Leukopenia ,medicine.disease ,EFFICACY ,030104 developmental biology ,chemistry ,Surgery ,business ,Thymine - Abstract
BACKGROUND The 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. METHODS Medical 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). RESULTS A 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. CONCLUSIONS Our 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. FUNDING Johannes J.M. Kwakman received an unrestricted research grant from Servier.
- Published
- 2018