TAS-102 improved survival, when contrasted with placebo, for patients with refractory colorectal cancer, though the drug showed no activity for the second-line treatment of patients with small cell lung cancer, according to a study published in the journal Lung Cancer.1

TAS-102 is an orally administered combination of a thymidine-based nucleic acid analogue, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil hydrochloride. TAS-102 has exhibited greater activity than cisplatin in small cell lung cancer xenograft mouse models; researchers therefore evaluated activity and tolerability of the combination drug in this multicenter, open-label, phase 2 study.

Investigators enrolled 18 patients with small cell lung cancer who were refractory or sensitive to frontline platinum-based chemotherapy and who required second-line treatment. Participants were randomly assigned to receive TAS-102 35 mg/m2 orally twice daily or chemotherapy with either topotecan or amrubicin.

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Of the 9 patients who received TAS-102, 8 discontinued treatment due to disease progression and 1 patient died as a result of clinical progression during the safety follow-up. In the control arm, 6 patients discontinued treatment for progressive disease and 1 due to an adverse event.

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The study was terminated early as it was unlikely that TAS-102 would be superior to chemotherapy. Median progression-free survival was 1.4 months with TAS-102, in contrast with 2.7 months with chemotherapy (hazard ratio, 3.76; 80% CI, 1.68-8.40).


  1. Scagliotti G, Nishio M, Satouchi M, et al. A phase 2 randomized study of TAS-102 versus topotecan or amrubicin in patients requiring second-line chemotherapy for small cell lung cancer refractory or sensitive to frontline platinum-based chemotherapy. Lung Cancer. 2016 Jun 27. doi: 10.1016/j.lungcan.2016.06.023 [Epub ahead of print]