Bevacizumab Added to Trifluridine and Tipiracil Improved Tumor Response Among Patients With Metastatic Colorectal Cancer

According to post hoc analysis results from the phase 3 SUNLIGHT trial, trifluridine and tipiracil plus bevacizumab improved tumor response compared to trifluridine and tipiracil alone among previously treated patients with metastatic colorectal cancer (mCRC). 

Study results demonstrated that trifluridine and tipiracil plus bevacizumab improved outcomes compared to trifluridine and tipiracil alone via RECIST v 1.1. “It has been suggested that tumor evaluation using RECIST may not capture the full spectrum of response to treatment, and there is a need to explore different parameters to assess response to treatment in mCRC clinical trials, with a focus on dynamic changes of the target lesion,” stated Julien Taieb, MD, PhD, CARPEM Comprehensive Cancer Center, Paris, France, and coauthors.

In this study, 492 patients who experienced disease progression on or after ≤ 2 prior lines of treatment were randomized to receive 35 mg/m² of twice daily trifluridine and tipiracil either alone (n = 246) or in combination with 5 mg/kg of bevacizumab (n = 246) in 28-day cycles. Primary end points for this analysis included rate of tumor shrinkage, rate of early tumor shrinkage, median duration of tumor shrinkage, and depth of response. 

At analysis, the rate of tumor shrinkage was 48% in the trifluridine and tipiracil plus bevacizumab arm and 21% of patients in the trifluridine and tipiracil arm. The rate of early tumor shrinkage was 39% and 17%, respectively. In patients who achieved early tumor shrinkage, the median duration of tumor shrinkage was 3.8 months in the trifluridine and tipiracil plus bevacizumab arm and 2.1 months in the trifluridine and tipiracil arm (hazard ratio [HR] 0.34; 95% confidence interval [CI], 0.22 to 0.53; P < .0001). The magnitude of the depth of response was greater in the trifluridine and tipiracil plus bevacizumab arm. 

“This analysis suggests that the previously observed survival benefit of treatment with [trifluridine and tipiracil] + bevacizumab compared to [trifluridine and tipiracil] in SUNLIGHT is accompanied by improvement of the more refined metrics of tumor response,” concluded Dr Taieb et al. 

Source:

Taieb J, Modest DP, Fakih M, et al. Impact of trifluridine/tipiracil plus bevacizumab on tumor shrinkage and depth of response in refractory metastatic colorectal cancer: analysis of the SUNLIGHT trial. Eur J Cancer. Published online: July 12, 2025. doi: 10.1016/j.ejca.2025.115644