Trifluridine/tipiracil or regorafenib in refractory metastatic colorectal cancer patients: An AGEO prospective “real life” study.

Abstract

4036 Background: Regorafenib (R) and trifluridine/tipiracil (T) have proved their efficacy in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard chemotherapy and targeted therapies. However, it remains unclear which drug should be administered first. Methods: This observational study was prospectively conducted in 13 centers between 6/2017 and 9/2019 in France. All consecutive pts with chemoresistant mCRC and receiving T and/or R were eligible. The aim of this study was to describe efficacy and tolerability of T and/or R. Overall survival (OS) and progression-free survival (PFS) of pts receiving T then R (T/R) and the opposite sequence (R/T) were also assessed. Results: A total of 237 pts (25% R and 75% T) were enrolled (109 male, median age: 67 years (32-91), mean previous lines of treatment: 2.5 (1-7)). Baseline ECOG PS was 0-1 in 77% of pts. As compared to R pts, T pts were significantly older (68 years vs 63; p = 0.033) and with > 3 metastatic sites (44% vs 30%, p = 0.018). Median OS were 6.6 and 6.2. months in the T and R group, respectively (NS). Median PFS were 2.4 and 2.1 months in the T and R group, respectively (NS). After matching 46 paired pts according to primary tumor resection, age and number of metastatic sites, a trend to a longer OS (9.5 vs 6.8 months; p = 0.17) and a significantly longer PFS (2.8 vs 2 months; p = 0.048) were observed in the T group. Among the overall population, 24% of pts received R/T or T/R sequence. Median OS from first treatment were 10.7 months in the R/T group and 9.8 months in the T/R (NS). Treatment sequence was not an independent prognostic factor for OS or PFS in multivariable analysis. Tolerability profiles were similar to previously published data, but dose reductions were more frequent in the R group (44 vs 27%, p = 0.008). Conclusions: Efficacy and safety results in this real life prospective study are in line with those published phase III trials. Both treatments seem similar in term of efficacy favoring T for clinical use as shown by the higher number of patients receiving this drug.