BACKGROUND:Chemotherapy has been widely accepted as standard for palliation in advanced non-small-cell 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 METHODS: Chemotherapy-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 > or = 2 cycles of first-line and 2 cycles of second-line therapy and patient survival was > or = 7 months from the start of treatment. For efficacy, time to progression, overall survival, response, and quality of life were analyzed. RESULTS:Three hundred thirty patients receivedgemcitabine 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 < or = 10% for both treatment strategies. Quality of life was significantly better in gemcitabine followed by docetaxel (P = 0.005). CONCLUSION:Single-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.
RCT Entities:
BACKGROUND: Chemotherapy has been widely accepted as standard for palliation in advanced non-small-cell 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 METHODS: Chemotherapy-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 > or = 2 cycles of first-line and 2 cycles of second-line therapy and patient survival was > or = 7 months from the start of treatment. For efficacy, time to progression, overall survival, response, and quality of life were analyzed. RESULTS: Three 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 < or = 10% for both treatment strategies. Quality of life was significantly better in gemcitabine followed by docetaxel (P = 0.005). CONCLUSION: Single-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.