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5PSQ-026 Efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer

ejhpharm · 2026-03-18 · canonical JSON source

24 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance According to SUNLIGHT phase III trial, the combination of trifluridine/tipiracil (FTD-TPI) in addition to bevacizumab (BEV) has demonstrated to have the potential to extend progression-free survival (PFS) and overall survival (OS) more than FTD-TPI alone in patients with metastatic colorectal cancer (mCRC).Aim and Objectives To assess the efficacy and security of FTD-TPI plus bevacizumab versus FTD-TPI monotherapy in patients with mCRC.Material and Methods Retrospective and observational study of patients treated between January 2023 and September 2025.The following data were collected: demographics (sex, age), cancer localisation, presence of RAS/BRAF mutations, line of treatment, ECOG performance status at the beginning of treatment, number of chemotherapy cycles administered, adverse events (AEs) and their grade, PFS and OS.Data were analysed using SPSS statistical software.Results A total of 35 patients were included: 13 women and 22 men. Of these, 23 received FTD-TPI and 12 received FTD-TPI plus BEV. The mean age was 67 years, and the most prevalent tumour location was the sigmoid colon adenocarcinoma (49%), followed by the rectum, right colon, caecum, ascending colon, and transverse colon adenocarcinoma. Furthermore, only 22 patients had undergone genetic testing, standing out two cases of BRAF mutation and nine cases of RAF mutation.Both drug regimens were mainly used as a third-line treatment (89%) for patients with ECOG performance status of 0-1 (86%) primarily. The average number of cycles administered was 4 [1-21], and adverse events (AEs) grade 2-4 were reported in 65% of patients receiving monotherapy and 50% of those receiving combination therapy (predominantly asthenia and haematological toxicity, followed by nausea, hepatotoxicity, and skin toxicity). FTD-TPI treatment had to be discontinued due to adverse effects in two cases.For the FTD-TPI group, the median PFS was 4 months (95% CI: 2,8-5,2) and the median OS was 7 months (95% CI: 4,4-9,6). For the FTD-TPI+BEV group, the median PFS was 5 months (95% CI: 3,6-6,4) and the median OS was 8 months (95% CI: 4,3-11,7). At the end of the study, 25% of patients were still undergoing treatment.Conclusion and Relevance Better outcomes were found in the FTD-TPI + BEV, obtaining better PFS and OS results than monotherapy with FTD-TPI without interfering in therapy safety.Conflict of Interest No conflict of interest