Abstract
Regorafenib (REG) and trifluridine/tipiracil (FTD/TPI) showed survival benefits in metastatic colorectal cancer patients previously treated with standard chemotherapies; therefore, we compared the efficacy and safety of these two treatments. Patients with metastatic colorectal cancer treated with REG or FTD/TPI as a salvage-line therapy from May 2014 to December 2017 were included. We retrospectively analyzed long-term survival, safety, and clinical outcomes. Among 134 patients, 57 and 77 received REG and FTD/TPI, respectively. The REG group received more prior systemic chemotherapies and significantly more frequent additional chemotherapies than the FTD/TPI group did. The median follow-up was 6.2 months, whereas the median overall survival was 9.9 and 11.4 months in the REG and FTD/TPI groups, respectively (hazard ratio = 0.954, p = 0.837). The median progression-free survival was 2.0 and 3.3 months in the REG and FTD/TPI groups, respectively (hazard ratio = 0.52, p = 0.00047), indicating significant differences, whereas the objective response and disease control rates did not differ. The median overall survival of patients with additional subsequent chemotherapies after disease progression was longer than that of patients without additional chemotherapy. The most frequent grade ≥3 adverse events were hypertension and neutropenia in the REG and FTD/TPI groups, respectively. Our study suggested that sequential use of both drugs may prolong survival.
Highlights
Remarkable progress in the development of efficacious drugs for metastatic colorectal cancer has prolonged the median overall survival (OS) from first-line therapy up to 30 months [1]
We retrospectively collected the clinical data of 134 patients with metastatic colorectal cancer (mCRC) who were treated with REG or FTD/TPI as salvage-line therapy at two Japanese tertiary referral centers, Kobe City Medical Center General Hospital and Sano Hospital, from May 2014 to December 2017
In the FTD/TPI combination group, 24 patients were PS 0 and only one patient was PS 1, while in the FTD/TPI monotherapy group, 29 patients were PS 0, 18 patients were PS 1, and 5 patients were PS 2, which suggested that better PS may lead to the combination therapy
Summary
The aim of this study was to compare the real-world efficacy and safety of FTD/ TPI and REG in patients with mCRC refractory to standard chemotherapies, and to suggest predictive or prognostic factors for treatment with these two drugs
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