BACKGROUND: Trifluridine/tipiracil (TAS-102, Lonsurf®), a novel oral anti-tumor 
agent combining an anti-neoplastic thymidine-based nucleoside analogue 
(trifluridine, FTD) with a thymidine phosphorylase inhibitor (tipiracil 
hydrochloride, TPI) presents a new treatment option for metastatic colorectal 
cancer (mCRC) patients refractory or intolerant to standard therapies. FTD/TPI 
was approved in the European Union (EU) in April 2016 and launched on the German 
market in August 15, 2016.
METHODS: We investigated the characteristics of patients (pts) with mCRC treated 
with FTD/TPI at 118 centers in Germany from January 12 to August 14, 2016 and 
analyzed the safety in a clinical real-world setting.
RESULTS: In Germany, a total of 226 mCRC patients were included into a 
compassionate-use-program (CUP) and received FTD/TPI. For 45.5% of patients 
(n = 101), 253 adverse events (AE) were documented, most of them drug-related 
(n = 135). From January 12 (2016) to March 2 (2017), 124 serious adverse events 
(SAE) were reported (74 drug related). The most common serious adverse drug 
reactions (SADR) were leukopenia (12 events), neutropenia (8 events), anemia (7 
events), diarrhea and nausea (5 events each) (observation period January 12 2016 
to October 7 2016). In total, 122 patients (54%) discontinued FTD/TPI treatment, 
mostly due to progression (n = 75) followed by AEs (n = 21), deaths (n = 16), 
and non-specified reasons (n = 16). Interestingly, 12 patients with ECOG PS ≥2 
achieved up to 3 cycles of FTD/TPI and in this patient population only 3 
treatment discontinuations due to AEs were documented and the safety profile was 
comparable to the entire population.
CONCLUSION: The patient characteristics as well as the safety profile of FTD/TPI 
documented in the German CUP were consistent with those reported in the pivotal 
trial RECOURSE without unexpected safety signals.