A previous phase 3 trial showed that treatment with trifluridine–tipiracil (FTD–TPI) prolonged overall survival among patients with metastatic colorectal cancer. New preliminary data from a phase 2 trial, suggest that the addition of bevacizumab to FTD–TPI might even further extend the survival of these patients.
Previously, a randomized, double-blind, placebo controlled phase III trial, evaluated the safety and efficacy of trifluridine/tipiracil (FTD-TPI) for metastatic colorectal cancer (mCRC).1 In this trial, FTD-TPI was shown to significantly prolong the overall survival compared to placebo. The hazard ratio for death in the FTD-TPI group versus the placebo group was 0.68 (95% confidence interval [CI], 0.58 to 0.81; P<0.001).
In the current phase II study, treatment FTD-TPI was compared to FTD-TPI in combination with the VEGFR inhibitor bevacizumab.2 Adult patients who received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer were included. The patients were randomly assigned (1:1)to receive FTD-TPI plus bevacizumab (combination group) or FTD-TPI alone (FTD-TPI group). The primary endpoint was overall survival, with progression-free survival and safety as secondary objectives, including the time to worsening of the Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 or 1 to 2 or more (on a scale from 0 to 5, with higher scores indicating greater disability).
In total, 246 patients were assigned to each group. The median overall survival was reported at 10.8 months in the combination group as compared to 7.5 months with FTD-TPI alone (hazard ratio: 0.61; 95% confidence interval [CI], 0.49 to 0.77; P<0.001). The median progression-free survival was 5.6 months in the combination group, which is more than twice as long as the2.4 months median PFS seen with FTD-TPI alone (hazard ratio for disease progression or death, 0.44; 95% CI, 0.36 to 0.54; P<0.001). The most common adverse events in both groups were neutropenia, nausea, and anemia. No treatment-related deaths were reported. The median time to worsening of the ECOG performance-status score from 0 or 1 to 2 or more was 9.3 months in the combination group and 6.3 months in the FTD-TPI group (hazard ratio, 0.54; 95% CI, 0.43 to 0.67)
Among patients with refractory metastatic colorectal cancer, treatment with FTD-TPI plus bevacizumab resulted in longer overall survival than FTD-TPI alone.
Top
