Abstract
Introduction
Regorafenib (R) and trifluridine/tipiracil (FTD/TPI) are of proven efficacy in metastatic
colorectal cancer (mCRC) patient's refractory to standard therapies. However, it remains
unclear which drug should be administered first.
Patients and Methods
This French observational study was prospectively conducted in 11 centers between
June 2017 and September 2019. All consecutive patients with chemorefractory mCRC and
receiving FTD/TPI and/or R were eligible. The aim was to evaluate the efficacy and
tolerability of FTD/TPI and/or R in real-world setting with adjusted analysis.
Results
A total of 237 mCRC patients (25% R and 75% FTD/TPI) were enrolled. As compared to
R, FTD/TPI patients were significantly older and with more metastatic sites. Median
OS and PFS were respectively 6.2 and 2.4 months in the FTD/TPI and 6.6 and 2.1 months
in the R group. After matching 46 paired patients according to a propensity score,
a trend to a longer OS (P = .58), and a significantly longer PFS (P = .048) were observed in the FTD/TPI group. In the 24% of patients receiving the
R/T or T/R sequence, median OS from first treatment was similar. Tolerability profiles
were similar to published data and dose reductions were more frequent in the R group.
Conclusion
Efficacy and safety results in this real-world prospective study are in line with
phase III trials. In a matched population, PFS was significantly longer in the FTD/TPI
group. Despite a limited number of patients, clinical outcomes seemed similar in patients
treated with the T/R or R/T sequence.
Keywords
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Article Info
Publication History
Published online: February 14, 2022
Accepted:
December 19,
2021
Received in revised form:
June 25,
2021
Received:
November 23,
2020
Identification
Copyright
© 2021 Elsevier Inc. All rights reserved.
