PURPOSE: Trifluridine/tipiracil (FTD/TPI; TAS-102, Lonsurf®), a novel form of 
chemotherapy for metastatic colorectal cancer (mCRC), has shown clinical benefit 
in the global, phase III RECOURSE trial, regardless of patient age. Here, we 
report the safety and tolerability profile of FTD/TPI from an expanded-access 
program (EAP) in the US patients with mCRC whose disease has progressed on the 
standard therapies.
METHODS: A total of 549 patients (≥ 18 years) with histologically confirmed mCRC 
following two or more regimens of standard therapy and an Eastern Cooperative 
Oncology Group performance status of 0 or 1 participated in this open-label EAP. 
During the 28-day treatment cycle, patients took FTD/TPI 35 mg/m2 twice daily 
for 5 days followed by 2 days of rest for 2 weeks, with a 14-day rest period. 
Data were collected for therapy duration, treatment discontinuation, and adverse 
events. Age-based post hoc analysis was performed to determine the safety of 
FTD/TPI in elderly (≥ 65 years) versus younger (< 65 years) patients.
RESULTS: FTD/TPI-treated patients in this EAP had a similar therapy duration and 
time to treatment discontinuation to those in the RECOURSE trial. The safety 
profile in elderly patients was consistent with that in younger patients, with 
no unexpected safety concerns.
CONCLUSIONS: This USA-based, open-label EAP has confirmed a similar safety and 
tolerability profile for FTD/TPI to that observed in the RECOURSE trial. 
Furthermore, FTD/TPI is well tolerated and can be considered as a treatment 
option in elderly patients with mCRC.
TRIAL REGISTRATION: NCT02286492.