Trifluridine-tipiracil and bevacizumab improve survival in colorectal cancer: NEJM

A new study by Gerald Prager and team showed that treatment with trifluridine-tipiracil (FTD-TPI) with bevacizumab led to a longer overall survival in patients with refractory metastatic colorectal cancer than FTD-TPI alone. The findings of this study were published in the New England Journal of Medicine.

Trifluridine-tipiracil therapy improved overall survival in patients with metastatic colorectal cancer in a prior phase 3 study. Initial findings from single-group and randomized phase 2 studies show that the addition of FTD-TPI to bevacizumab therapy may increase survival.

Adult patients with advanced colorectal cancer who had received no more than two prior chemotherapy regimens were randomly allocated, in a 1:1 ratio, to receive either FTD-TPI plus bevacizumab (combination group) or FTD-TPI alone (FTD-TPI group). Overall survival was the main goal. The time until the Eastern Cooperative Oncology Group (ECOG) performance-status score worsened from 0 or 1 to 2 or more (on a scale from 0 to 5, with higher scores indicating more impairment) were secondary end goals for progression-free survival and safety.

The key findings of this study were:

1. Each group received 246 patients in total. In the combination group, the median overall survival was 10.8 months, but in the FTD-TPI group, it was 7.5 months (hazard ratio for death, 0.61; 95% confidence interval [CI], 0.49 to 0.77; P 0.001).

2. In the combination group, the median progression-free survival was 5.6 months, whereas in the FTD-TPI group, it was 2.4 months (hazard ratio for progression of the disease or death, 0.44; 95% CI, 0.36 to 0.54; P0.001).

3. Neutropenia, nausea, and anemia were the most frequent side effects in both groups. There were no known treatment-related fatalities.

4. In the combination group, it took an average of 9.3 months before the ECOG performance-status score worsened from 0 or 1 to 2 or greater, whereas in the FTD-TPI group, it took an average of 6.3 months.

Reference:

Prager, G. W., Taieb, J., Fakih, M., Ciardiello, F., Van Cutsem, E., Elez, E., Cruz, F. M., Wyrwicz, L., Stroyakovskiy, D., Pápai, Z., Poureau, P.-G., Liposits, G., Leger, C., Vidot, L., & Tabernero, J. (2023). Trifluridine–Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. In New England Journal of Medicine (Vol. 388, Issue 18, pp. 1657–1667). Massachusetts Medical Society. https://doi.org/10.1056/nejmoa2214963