Open, Randomized, Phase II Study of Single-Agent Gemcitabine and Docetaxel as First- and Second-Line Treatment in Patients with Advanced Non–Small-Cell Lung Cancer

BackgroundChemotherapy has been widely accepted as standard for palliation in advanced non–smallcell lung cancer. Gemcitabine and docetaxel are active as single agents. Our previous experience indicates that single-agent therapy, if given sequentially, could be an alternative to doublet combination chemotherapy and that sequence and schedule matter.Patients and MethodsChemotherapy-naive patients with stage IIIB-IV non–small-cell lung cancer were randomized to receive first-line 3-weekly gemcitabine or docetaxel. At progression, patients received second-line therapy with the other agent. Treatment was considered feasible if 30% of the evaluable patients had ≥ 2 cycles of first-line and 2 cycles of second-line therapy and patient survival was ≥ 7 months from the start of treatment. For efficacy, time to progression, overall survival, response, and quality of life were analyzed.ResultsThree hundred thirty patients received gemcitabine followed by docetaxel or docetaxel followed by gemcitabine. Treatment was feasible for 60 patients (38%) with gemcitabine followed by docetaxel and for 80 patients (49%) with docetaxel followed by gemcitabine; treatment favored docetaxel followed by gemcitabine (P = 0.03539). Median survival for gemcitabine followed by docetaxel and docetaxel followed by gemcitabine was 6.3 months and 8.6 months, and 1-year survival rate was 28% and 31%, respectively. Objective response rates were ≤ 10% for both treatment strategies. Quality of life was significantly better in gemcitabine followed by docetaxel (P = 0.005).ConclusionSingle-agent gemcitabine and docetaxel are feasible as defined for both sequences but treatment favors docetaxel followed by gemcitabine. Thus, it is reasonable to state that single-agent therapy given sequentially might be a candidate for palliation and therefore should be investigated in comparison with combination therapy.