Clinical outcomes and safety of trifluridine–tipiracil with or without bevacizumab in metastatic colorectal cancer: A real-world study from Saudi Arabia.

Abstract

e23415 Background: Trifluridine–tipiracil (TAS-102) is an established later-line therapy for metastatic colorectal cancer (mCRC). However, real-world data describing clinical outcomes and prognostic factors—particularly from Middle Eastern populations—remain limited. Our aim was to assess the safety and efficacy of TAS-102 with or without bevacizumab in patients with mCRC at a single center in Saudi Arabia. Methods: We conducted a retrospective cohort study of adults with mCRC treated with TAS-102, with or without bevacizumab, at King Fahad Medical City (KFMC), a tertiary care center in Saudi Arabia, between 2020 and 2025. Progression-free survival (PFS) was the primary endpoint. Secondary endpoints included overall survival (OS), safety, and identification of prognostic factors. Survival outcomes were estimated using the Kaplan–Meier method, and associations were evaluated using Cox proportional hazards regression. Results: A total of 111 patients were included (mean age 60.1 ± 11.8 years; 53.2% female). TAS-102 was administered as third-line therapy in 84.7% of patients, and 62.2% received concomitant bevacizumab. At a median follow-up of 8.8 months, median PFS was 2.9 months (95% CI, 2.3–3.5) and median OS was 12.3 months (95% CI, 10.9–14.8). Compared with TAS-102 alone, the addition of bevacizumab was associated with improved PFS (3.4 vs 2.1 months; p = 0.005) and OS (14.8 vs 9.0 months; p = 0.006). On multivariable analysis, liver metastases were independently associated with poorer OS (HR 2.50; 95% CI, 1.37–4.55; p = 0.003), while KRAS mutation was associated with shorter PFS (HR 1.76; 95% CI, 1.16–2.69; p = 0.008). Grade ≥3 neutropenia and anemia occurred in 18.0% and 9.9% of patients, respectively. Conclusions: In a real-world cohort of heavily pretreated patients with mCRC, TAS-102 demonstrated clinical outcomes comparable to those reported in clinical trials. The addition of bevacizumab was associated with improved survival without unexpected safety signals. KRAS mutation status and the presence of liver metastases were associated with prognosis and may support risk stratification and treatment decision-making in routine clinical practice.