4CPS-195 Evaluation of the effectiveness and safety of the bevacizumab-trifluridine-typiracyl regimen in a multicentric study

<h3>Background and Importance</h3> Colorectal cancer (CRC) is the third most common cancer and the second most deadly worldwide. The efficacy data of trifluridine/tipiracil (TT) plus bevacizumab in treatment of metastatic CRC who have received two previous antineoplastic treatment regimens come from phase III SUNLIGHT clinical trial (compared with TT monotherapy), with the variable primary efficacy overall survival (OS) and as a secondary objective progression-free survival (PFS), obtaining a median difference of 6.7 months (HR:0.40; 95% CI: (0.30–0.55); p &lt; 0.001) with a 6-month OS of 70% and 3.2 months (HR:0.44; 95% CI: (0.36–0.54); p&lt; 0.001) with a 6 month PFS of 43% respectively. <h3>Aim and Objectives</h3> To evaluate the effectiveness and safety of the bevacizumab-trifluridine-tipiracil (BTT) regimen in metastatic CRC. <h3>Material and Methods</h3> A multicentre retrospective descriptive study was carried out that included patients treated with the BTT regimen. The regimen was administered as follows: trifluridine-tipiracil 35 mg/m²/dose twice daily on days 1–5 and 8–12 every 28 days plus bevacizumab 5 mg/kg every 2 weeks. The following variables were collected: sex, age, functional status at the beginning of treatment (ECOG), treatment line and number of cycles. To assess effectiveness, OS and PFS were measured. Safety was assessed by the appearance of adverse events (AE) recorded in clinical history. <h3>Results</h3> 40 patients with a mean age of 66 ± 11 years (sex: 80% men) were included. 57.5% (23/40) of patients had ECOG 0 and 42.5% (17/40) had ECOG 1. The median number of treatment lines received was five, the median number of cycles received was four and the 45% (18/40) of patients discontinued treatment, of which 83.3% (15/18) was due to disease progression. OS at 6 months was 90% (36/40) and PFS at 6 months was 60% (24/40). Regarding safety, 65% (26/40) experienced some grade 3–4 AE, the most common being neutropenia 40% (16/40) and anaemia 12.5% (5/40). Only two patients did not present any adverse effects. <h3>Conclusion and Relevance</h3> The data obtained in our study show effectiveness superior to that obtained in the SUNLIGHT clinical trial which may be due to the high percentage of patients with ECOG 0–1, in addition to a with a safety profile in line with what was observed in that trial. Studies with a larger population and a longer follow-up period would be necessary to know the real-life effectiveness of this regimen. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest