DI-064 Evaluation of tas-102 as an expanded access in refractory colorectal cancer

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TAS-102 is an oral agent that combines trifluridine and tipiracil hydrochloride. Trifluridine is the active cytotoxic component with antitumour effects and tipiracil is an inhibitor that prevents the rapid degradation of trifluridine. The FDA authorised this drug in September 2015 for the treatment of patients diagnosed with colorectal cancer refractory to one or two previous chemotherapy regimens that contained fluoropyrimidine, platinum agents and taxanes or irinotecan, inhibitors of vascular endothelial growth factor and inhibitors of epidermal growth factor receptor in the case of wild RAS.


To evaluate the effectiveness and tolerability of TAS-102, based on overall survival (OS) and progression free survival (PFS) in the treatment of refractory colorectal cancer.

Material and methods

A retrospective study was conducted including patients diagnosed with advanced colorectal cancer authorised to receive TAS-102. The request forms were applied and evaluated between March and July 2016 by an expanded access to the drug, and the patients were followed until 15 October. Clinical data were obtained from the electronic history CernerMillenium and the variables were: age, gender, progression date, death date and adverse effects.


Treatment was requested for 32 patients; 30 were authorised to receive TAS-102. Of them, only 24 patients started treatment. 5 patients did not start treatment due to worsening of disease during the process of authorisation, and another 1 because of supply problems.


There were 15 men and 9 women, and median age was 66.3 years. Most patients progressed, and only 6 continued receiving TAS-102. Median PFS was 2.25 months (range 0.47–6.47). During treatment, 6 patients died. Median OS was 3.27 months (range 0.70–6.47). The toxicity profile showed haematologic effects such as: neutropenia (70.3%), anaemia (50%), leukopenia (37.5%) and thrombopenia (25%). Other adverse effects were less frequent: diarrhoea (8.3%), asthenia (8.3%), vomiting (8.3%) and neuropathy (4.2%).


Although treatments were approved and received for all patients, 20% never started TAS-102. OS was lower than in the pivotal study because the study was not long enough to achieve better results. On the other hand, PFS was higher than in the pivotal study which was 2.0 months. Adverse effects confirmed haematologic toxicity.

References and/or acknowledgements

N Engl J Med2015;372:1909–19. doi:10.1056/NEJMoa1414325.

References and/or acknowledgements

No conflict of interest

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