Background Colorectal Cancer was the third frequent cancer worldwide in the year 2012, with approximately 1.4 million newly diagnosed cases per year.
Chemotherapy such as 5-Fluoruracil in combination with Irinotecan or Oxaliplatin and targeted therapy (anti-VEGF or anti-EGFR) are considered global standard in first or second line treatment and median overall survival (OS) has been prolonged significantly over the last decades.(1) However, there is still great demand on third or later lines of treatment for patients who are keeping up good physical conditions. Trifluridine/Tipiracil (TAS-102) is a new oral nucleoside antitumor agent and was first approved in Japan in 2014 and in Europe by EMA in 2016. The drugs active cytotoxic agent is Trifluridine while Tipiracil prevents rapid degradation of Trifluridine and allows the maintenance of adequate plasma levels. The primary anticancer mechanism appears to be DNA incorporation in tumour tissue.
Aim: Retrospective data of Tipiracil/Trifluridine on adverse events and safety in the treatment of mCRC in clinical practice remains rare. The aim of this multicentre study was to evaluate treatment response and safety of Tipiracil/Trifluridine therapy in a real-life setting and compare clinical outcomes to previous studies.
Methods: The retrospective study analysed 48 patients who were diagnosed with colorectal cancer in the years 1999 to 2017 at the Department of Medicine I, Division of Oncology, Medical University Vienna-General Hospital and Department of Medical Oncology, University Hospital Zurich. The relevant parameters and variables such as age, sex, body mass index, disease location, comorbidities, laboratory parameters, molecular status, therapeutic regimen, length of therapy and outcome were obtained and statistically analysed by using SPSS®
Results: Median PFS from start of treatment to progression was 4 months (95% confidence interval [CI]: 2.2 to 5.9 months) and OS from start of treatment to death was 8.9 months (95% CI: 8.7 to 12.6 months). The most commonly-reported adverse events of any grade were anaemia (37.5%), fatigue (31.3%) and leukopenia/neutropenia (29.2% each). Upon Trifluridine/Tipiracil treatment no patient showed complete remission and one patient (2.1%) showed partial remission. Disease control was achieved in 19 patients (45.2%). No association between disease control rate and age or therapy prior to Trifluridine/Tipiracil (regorafenib or other treatment) was observed (p=0.516).