Renal impairment is a risk factor for trifluridine/tipiracil-induced adverse events in metastatic colorectal cancer patients: An exploratory analysis of REGOTAS study

Abstract

Abstract Background Renal impairment increases the risk of hematologic events (AEs) in patients on trifluridine/tipiracil (FTD/TPI). This study aimed to clarify the specific types of AEs associated with renal impairment in patients with metastatic colorectal cancer (mCRC) on FTD/TPI, using a real-world dataset. Methods Among the patients included in the REGOTAS study (a retrospective study of FTD/TPI versus regorafenib), those treated with FTD/TPI were evaluated. Creatinine clearance (Ccr) values of <30, 30–60, 60–90, and >90 mL/min were defined as severe, moderate, mild renal impairment, and normal renal function, respectively. Renal impairment was analyzed as a risk factor for grade 3 or higher AEs using a logistic regression model. Overall survival (OS) and progression-free survival (PFS) based on renal impairment were evaluated. Results In all, 309 were included in the analysis, and 124, 130, and 55 patients were divided into the normal, mild, and moderate-to-severe groups, respectively. Risk of grade 3 or higher neutropenia was significantly higher in the moderate-to-severe group (odds ratio, 3.47; 95% confidence interval, 1.45–8.30; P=0.005), but the risk of non-hematologic AEs did not increase in any of the groups. The OS and PFS of the mild and moderate-to-severe groups were comparable to those in the normal group. Conclusion Patients with mCRC and moderate/severe renal impairment on FTD/TPI therapy may develop severe neutropenia; however, FTD/TPI is considered a treatment option because of its clinical benefit.