TAS-102 in metastatic colorectal cancer (mCRC): efficacy, tolerability, and quality of life in heavily pretreated elderly patients: a real-life study

Giuseppe Cicero MD PhD, Raffaele Addeo MD, Rossella De Luca PhD, Giuseppe Lo Re MD PhD, Leonardo Gulotta MD, Pierenrico Marchesa MD, Gaspare Gulotta MD PhD


Background: TAS-102 is an oral monotherapy, combining trifluridine and tipiracil hydrochloride, indicated for the treatment of pretreated metastatic colorectal cancer (mCRC). The aim of this real-life study is to evaluate the efficacy and safety of TAS-102 in heavily pretreated elderly patients with mCRC whose disease has progressed with standard therapies.

Methods: In this retrospective observational study, we enrolled 50 elderly patients >70 years of age (median age 78 years) with a diagnosis of mCRC who were previously treated or were not considered candidates for treatment with other available therapies. Patients aged >70 years with advanced colorectal cancer and with an ECOG performance status of grade 0 (n=18) or grade 1 (n=32) were included. Overall survival and progression-free survival were the primary endpoints, whereas objective response rate, tolerability, and quality of life were the secondary endpoints.

Results: Treatment with TAS-102 appeared to be well tolerated and side effects were generally mild, achieving disease control and a benefit on quality of life. The median overall survival was 6.7 (95% CI 5.7–11.3) and the median progression-free survival was 2.1 months (95% CI 1.2–3.2), estimated using the Kaplan– Meier method.

Conclusion: TAS-102 represents a manageable and effective therapeutic opportunity and appeared to be well tolerated with generally mild side effects in elderly patients with mCRC who were heavily pretreated with standard therapies.

Article Details

Article Type

Original Research



Publication Dates

Accepted: ; Published: .


Cicero G, Addeo R, De Luca R, Lo Re G, Gulotta L, Marchesa P, Gaspare G. TAS-102 in elderly patients with mCRC: a real-world study. Drugs in Context 2020; 9: 2020-6-3. DOI: 10.7573/dic.2020-6-3

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