KEY TAKEAWAYS
- The phase 3 (SUNLIGHT) trial aimed to evaluate the effect of FTD-TPI treatment on overall survival in patients with metastatic colorectal cancer.
- Patients who had received no more than two cycles of chemotherapy were randomly assigned to receive either FTD-TPI plus bevacizumab.
- The combination group had a median overall survival of 10.8 months, compared to 7.5 months for the FTD-TPI group.
- The most common side effects were neutropenia, nausea, and anemia, and they occurred in both study groups.
- The study concluded that combining FTD-TPI with bevacizumab improved overall survival in patients with metastatic colorectal cancer, providing promising preliminary results for further investigation.
Trifluridine-tipiracil (FTD-TPI) treatment improved overall survival in a phase 3 trial for patients with metastatic colorectal cancer. Single-group and randomized phase 2 trials have shown promising preliminary results, suggesting that treatment with FTD-TPI and bevacizumab may increase survival. Patients with advanced colorectal cancer who had previously been treated with no more than two cycles of chemotherapy were randomly randomized to receive either FTD-TPI plus bevacizumab (combination group) or FTD-TPI alone (FTD-TPI group) at a 1:1 ratio. Overall survival was the critical measure of success. Time to worsening of Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 or 1 to 2 or more (on a scale of 0 to 5, with higher scores indicating more significant impairment) and safety were secondary end objectives.
The two groups each had 246 patients. The combination group had a median overall survival of 10.8 months, while the FTD-TPI group only had 7.5 months (hazard ratio for death, 0.61; 95% CI, 0.49 to 0.77; P<0.001). Median progression-free survival was 5.6 months for those who received the combination versus 2.4 months for those who received FTD-TPI alone (95% confidence interval [CI], 0.36 to 0.54; P<0.001). The most common side effects were neutropenia, nausea, and anemia, and they occurred in both study groups. No deaths were attributed to any aspect of the treatment. In the combination group, patients waited 9.3 months before their ECOG performance-status score worsened from 0 or 1 to 2 or more, while in the FTD-TPI group, patients waited 6.3 months (hazard ratio, 0.54; 95% CI, 0.43 to 0.67). Overall survival was improved when FTD-TPI was combined with bevacizumab in patients with resistant metastatic colorectal cancer.
Source:https://pubmed.ncbi.nlm.nih.gov/37133585/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT04737187
Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, Cruz FM, Wyrwicz L, Stroyakovskiy D, Pápai Z, Poureau PG, Liposits G, Cremolini C, Bondarenko I, Modest DP, Benhadji KA, Amellal N, Leger C, Vidot L, Tabernero J; SUNLIGHT Investigators. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023 May 4;388(18):1657-1667. doi: 10.1056/NEJMoa2214963. PMID: 37133585.
