Exploratory analysis of the effect of FTD/TPI in mCRC patients treated in RECOURSE by different prognostic factors: impact on ECOG PS

In the Phase III RECOURSE study, patients with metastatic colorectal cancer (mCRC) refractory to standard therapies demonstrated significantly extended overall survival and progression-free survival with trifluridine/tipiracil (FTD/TPI) compared with placebo, along with an acceptable safety profile.

This exploratory analysis of all patients treated in RECOURSE with FTD/TPI or placebo investigated Eastern Cooperative Oncology Group performance score (ECOG PS) shift from baseline to treatment discontinuation in patients with good prognosis.

Baseline characteristics were generally similar between the two treatment groups. For good prognosis patients treated with FTD/TPI (n = 256), 89.1% (96.2% and 78.0% of those with a baseline ECOG PS of 0 [n = 156] or 1 [n = 100], respectively), continued to have an ECOG PS 0–1 at treatment discontinuation. For good prognosis patients treated with placebo (n = 119), 83.2% (90.7% and 70.5% of those with a baseline ECOG PS of 0 [n = 75] or 1 [n = 44], respectively) continued to have an ECOG PS 0–1 at treatment discontinuation. For poor prognosis patients treated with FTD/TPI (n = 250), 78.4% (88.3% and 66.4% with a baseline ECOG PS of 0 [n = 137] or 1 [n = 113], respectively) continued to have an ECOG PS 0–1 at treatment discontinuation. For poor prognosis patients treated with placebo (n = 129), 75.2% (84.8% and 65.1% with a baseline ECOG PS of 0 [n = 66] or 1 [n = 63], respectively) continued to have an ECOG PS 0–1 at treatment discontinuation. Median time to deterioration to ECOG PS ≥ 2 in the ITT population was significantly longer in patients treated with FTD/TPI compared with placebo (5.7 months vs 4.0 months, respectively; HR 0.66; 95% CI: 0.56, 0.78; p < 0.001). For patients with good prognostic characteristics (n = 386), median time to deterioration to ECOG PS ≥ 2 was significantly longer in patients treated with FTD/TPI compared with placebo (7.8 months vs 4.7 months, respectively; HR 0.53; 95% CI: 0.41, 0.69; p < 0.0001). For patients with poor prognostic characteristics (n = 414), median time to deterioration to ECOG PS ≥ 2 was numerically longer in patients treated with FTD/TPI compared with placebo (4.2 months vs 3.4 months, respectively; HR 0.80; 95% CI: 0.64, 1.00; p = 0.049).

A higher percentage of good prognosis patients with mCRC at PS 0 or 1 at study entry remained at PS 0 or 1 at the end of the study when treated with FTD/TPI versus placebo for both good and poor prognosis. Time to treatment deterioration was prolonged by FTD/TPI in all prognostic subgroups versus placebo. Maintenance of ECOG PS may lead to further treatment lines and improved patient outcomes.