Second-line treatment of non-small cell lung cancer by biweekly gemcitabine and docetaxel plus /- granulocyte-macrophage colony stimulating factor and low dose aldesleukine

Background: The antitumor activity of a novel biweekly gemcitabine (G) + docetaxel (D) regimen +/- granulocyte-macrophage colony stimulating factor (GM-CSF) and aldesleukine (IL-2) has been evaluated in a phase II trial in advanced pretreated non-small cell lung cancer (NSCLC). Results: The treatment was well tolerated. The 42.3% response rate exceeded the predefined target activity, while time to progression (TTP) and overall survival (OS) were 7 and 11.2 months, respectively. A greater objective response rate (58.3% vs. 28.6%) and an increased number of eosinophils, basophils and activated mononuclear blood cells were observed in those patients who also received cytokine administration. Methods: Twenty-six NSCLC patients received second line G (1,000 mg/m(2)) and D (75 mg/m(2)) every 15 days. 12/26 patients also received s.c. GM-CSF (100 mu g, days 2-6) and s.c. IL-2 (0.5 MIU/twice daily, days 7-14 and 16-29) by random selection. Conclusion: The biweekly GD regimen is a safe and active second-line treatment in NSCLC. Addition of immune-adjuvant cytokines' may enhance the activity of this therapeutic combination.