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

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.

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.

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).

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.