• Cancer investigation · Oct 2008

    Phase I clinical study of three times a day oral administration of TAS-102 in patients with solid tumors.

    • Michael J Overman, Scott Kopetz, Gauri Varadhachary, Masakazu Fukushima, Keizo Kuwata, Akira Mita, Robert A Wolff, Paulo Hoff, Henry Xiong, and James L Abbruzzese.
    • University of Texas, M.D. Anderson Cancer Center, Houston, Texas, USA. moverman@mdanderson.org
    • Cancer Invest. 2008 Oct 1;26(8):794-9.

    AbstractTAS-102 is a novel formulation of the fluorinated pyrimidine analogue trifluorothymidine (FTD) with an inhibitor of thymidine phosphorylase. The purpose of this study was to determine the MTD and DLT for TAS-102 administered three times a day on days 1-5 and 8-12 every 4 weeks. Fifteen patients were enrolled with two patients experiencing dose-limiting fatigue and granulocytopenia at the first dose level (80 mg/m2/day). Granulocytopenia was the primary toxicity: 7 patients experienced grade 3 or 4 granulocytopenia with the first course. No responses were noted, but nine patients demonstrated prolonged stable disease in this heavily pretreated 5-FU refractory population.

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