Abstract 87P
Background
Metastatic colorectal cancer (mCRC) remains a significant clinical challenge, with limited survival rates despite treatment advancements. In the SUNLIGHT pivotal study (Prager, et al., 2023), the combination of trifluridine/tipiracil (FTD/TPI) with bevacizumab vs FTD/TPI monotherapy showed a statistical and clinically significant increase in overall survival (OS) and progression-free survival (PFS) with improved HR-QoL. The current study aimed to evaluate the efficacy and clinicopathological factors associated with FTD/TPI in combination with bevacizumab in refractory mCRC patients, emphasizing survival outcomes and treatment responses in real clinical practice.
Methods
A recent retrospective, observational, multicenter study included 200 mCRC patients treated with FTD/TPI (Koumarianou et al., 2023). In this cohort, 151 patients were treated with FTD/TPI monotherapy and 49 patients were treated with 3-weekly bevacizumab as third-line therapy or beyond. Clinicopathological characteristics, treatment responses, and survival outcomes were assessed. Cox regression analysis was employed to identify prognostic factors.
Results
The median OS for patients receiving FTD/TPI with bevacizumab (n=49) was 14.2 months (95% CI: 8.9-19.5), compared to 11.1 months (95% CI: 8.1-14.2) for those receiving FTD/TPI alone (n=151). PFS was prolonged in the combination therapy group (median PFS: 5.1 months, 6-month PFS rate: 46.0%) compared to monotherapy (median PFS: 4.6 months, 6-month PFS rate: 39.3%). Clinicopathological analysis revealed no significant differences between treatment groups in primary tumor sites or molecular characteristics. However, patients receiving combination therapy demonstrated higher rates of metastatic disease at diagnosis (53.1%) compared to monotherapy (38.4%). Multivariate analysis identified KRAS mutation and ECOG performance status as significant prognostic factors for both PFS and OS.
Conclusions
Our real-world study highlights the potential benefits of FTD/TPI and bevacizumab combination therapy in refractory mCRC. Improved survival outcomes were observed, suggesting a potential delay in disease progression with combination therapy.
Clinical trial identification
NCT04965870.
Legal entity responsible for the study
The authors.
Funding
Servier.
Disclosure
A. Koumarianou: Financial Interests, Institutional, Research Grant: Merck. E. Res: Financial Interests, Invited Speaker: MSD. N. Androulakis: Financial Interests, Invited Speaker: BMS. I. Boukovinas: Financial Interests, Invited Speaker: BMS, MSD, AstraZeneca. G. Oikonomopoulos: Financial Interests, Invited Speaker: BMS, MSD. I. Souglakos: Financial Interests, Invited Speaker: Servier. M.V. Karamouzis: Financial Interests, Funding: LEO. All other authors have declared no conflicts of interest.