ESMO open · 2026
Clinical outcomes of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil or regorafenib in metastatic colorectal cancer: a multicenter cohort study.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Moik F, Huemer F, Doleschal B, Taghizadeh H, Reimann P, Kostmann S M, Wagner L, Abdel Hamid M, Zimmer K C, Suppé S A, Bachleitner C, Schaberl-Moser R, Amann A, Wolf D, Greil R, Jost P J, Winder T, Rumpold H, Weiss L, Gerger A, Seeber A, Riedl J M
Аннотация
BACKGROUND: In patients with pretreated metastatic colorectal cancer (mCRC), trifluridine/tipiracil (FTD-TPI) + bevacizumab has superior efficacy compared with FTD-TPI alone. However, real-world data on outcomes and comparisons with other established therapies including regorafenib are scarce. Additionally, evidence suggests that molecular alterations, such as KRASG12 mutations, may affect FTD-TPI efficacy. We aimed to compare clinical outcomes of patients with mCRC treated with FTD-TPI + bevacizumab, FTD-TPI, or regorafenib across molecular subgroups.
PATIENTS AND METHODS: This retrospective cohort study included 509 patients treated at six Austrian cancer centers between January 2015 and December 2022. The primary outcome was progression-free survival (PFS), with overall survival (OS) and disease control rate (DCR) as secondary outcomes. Between-group differences were analyzed using Cox and logistic regression. A propensity score analysis using inverse probability of treatment weighting (IPTW) was conducted. Flexible parametric models and restricted mean survival time (RMST) analyses were used to account for time-dependent differences in PFS/OS.
RESULTS: In propensity score analysis, patients treated with FTD-TPI + bevacizumab (n = 130) versus FTD-TPI (n = 227) alone or regorafenib (n = 152) had longer PFS [IPTW-adjusted hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.51-0.92, P = 0.012] and higher DCR (IPTW-adjusted odds ratio 3.35, 95% CI 1.81-6.20, P < 0.001). The IPTW-adjusted HR for OS was 0.80 (95% CI 0.58-1.12, P = 0.203). A modest OS benefit of FTD-TPI + bevacizumab was observed within the first 12 months. In RMST-analysis, OS was 12.1 months (95% CI 11.4-12.8 months) for FTD-TPI + bevacizumab compared with 10.6 months (95% CI 9.9-11.2 months) for the controls (P = 0.003). Outcomes were consistent across key molecular subsets, including KRAS and KRASG12 mutations.
CONCLUSIONS: In this large real-world cohort of patients with mCRC, FTD-TPI + bevacizumab was associated with improved PFS and DCR compared with FTD-TPI or regorafenib, with consistent benefit across most molecular subgroups, including KRASG12 mutations.
PATIENTS AND METHODS: This retrospective cohort study included 509 patients treated at six Austrian cancer centers between January 2015 and December 2022. The primary outcome was progression-free survival (PFS), with overall survival (OS) and disease control rate (DCR) as secondary outcomes. Between-group differences were analyzed using Cox and logistic regression. A propensity score analysis using inverse probability of treatment weighting (IPTW) was conducted. Flexible parametric models and restricted mean survival time (RMST) analyses were used to account for time-dependent differences in PFS/OS.
RESULTS: In propensity score analysis, patients treated with FTD-TPI + bevacizumab (n = 130) versus FTD-TPI (n = 227) alone or regorafenib (n = 152) had longer PFS [IPTW-adjusted hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.51-0.92, P = 0.012] and higher DCR (IPTW-adjusted odds ratio 3.35, 95% CI 1.81-6.20, P < 0.001). The IPTW-adjusted HR for OS was 0.80 (95% CI 0.58-1.12, P = 0.203). A modest OS benefit of FTD-TPI + bevacizumab was observed within the first 12 months. In RMST-analysis, OS was 12.1 months (95% CI 11.4-12.8 months) for FTD-TPI + bevacizumab compared with 10.6 months (95% CI 9.9-11.2 months) for the controls (P = 0.003). Outcomes were consistent across key molecular subsets, including KRAS and KRASG12 mutations.
CONCLUSIONS: In this large real-world cohort of patients with mCRC, FTD-TPI + bevacizumab was associated with improved PFS and DCR compared with FTD-TPI or regorafenib, with consistent benefit across most molecular subgroups, including KRASG12 mutations.