Phase II randomized study of weekly docetaxel alone or plus UFUR treatment in non-small cell lung cancer patients who failed previous chemotherapy.

Purpose: This study aimed to assess the feasibility and efficacy of adding UFUR (UFT, tegafur/uracil) into weekly docetaxel treatment for non-small cell lung cancer (NSCLC) patients who failed previous platinum-based chemotherapy.

Methods: Patients were randomized into two arms: docetaxel 40mg/m(2) intravenous infusion (IV) on days 1 and 8 of every 3 weeks (arm D), and docetaxel 35mg/m(2) IV on days 1 and 8 plus daily oral UFUR 150mg/m(2) of every 3 weeks (arm DU), with arm D as a control arm. Treatment was given to a maximum of 6 cycles and carried out in the outpatient clinic.

Results: From January 2005 to March 2006, 48 patients were enrolled and randomized into the study, with 24 patients in each arm. The mean number of cycles of treatment was 4 in the D arm and 3.5 in the DU arm. Objective response rates were 29.2% in the D arm and 8.3% in the DU arm (p=0.067). Toxicities were few and mild in degree in both arms. Median time to disease progression was 4.5 months in the D arm and 2.1 months in the DU arm (p=0.4682). Median survival time was 10.9 months in the D arm and 15.2 months in the DU arm (p=0.8442).

Conclusions: The addition of UFUR to weekly docetaxel treatment did not improve response rate and time to disease progression in NSCLC patients who failed previous platinum-based chemotherapy.