Feasibility and effectiveness of trifluridine/tipiracil in metastatic colorectal cancer: real-life data from The Netherlands

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

*Corresponding author for this work

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Abstract

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. 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). 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 ae<yen>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. 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. Johannes J.M. Kwakman received an unrestricted research grant from Servier.
Original languageEnglish
Pages (from-to)482-489
Number of pages8
JournalInternational Journal of Clinical Oncology
Volume23
Issue number3
DOIs
Publication statusPublished - 1 Jun 2018

Keywords

  • Trifluridine/tipiracil
  • TAS-102
  • Metastatic colorectal cancer
  • Compassionate use
  • Feasibility
  • QUALITY-OF-LIFE
  • THYMIDINE PHOSPHORYLASE
  • PERFORMANCE STATUS
  • ANTITUMOR-ACTIVITY
  • NEUTROPENIA
  • PREDICTOR
  • SURVIVAL
  • EFFICACY
  • TRIAL

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