Gemcitabine as second-line treatment for advanced non-small-cell lung cancer: A phase II trial

Purpose: To investigate the activity and toxicity of gemcitabine as a singl e agent in patients with advanced non-small cell lung cancer (NSCLC) after recurrence or failure of previous treatment with a platinum-containing regi men, Patients and Methods: From November 1995 to October 1997, 83 patients with stage IIIB or IV NSCLC received gemcitabine 1,000 mg/m(2) once a week for 3 weeks every 28 days. Responses were assessed every two treatment courses. The median age of the patients was 63 years; Eastern Cooperative Oncology G roup performance status was 0 to 1 in 62 patients and 2 in 21 patients. The predominant histology war squamous (39 patients); 49 patients had stage IV disease and 34 patients had stage III disease (33 stage IIIB and one stage IIIA). Results: Sixteen patients (19%) achieved a partial response to treatment; t he median duration of response was 29 weeks (range, 6 to 50 weeks). Treatme nt was well tolerated: grade 2 to 3 (World Health Organization standardized response criteria) leukopenia and thrombocytopenia occurred in 23% and 20% of patients, respectively Mild asthenia was observed in 16% of patients, a nd peripheral edema in 5% of patients. Nausea and vomiting were present in 16% of patients. Conclusion: In this experience, gemcitabine showed significant activity wit hout relevant toxicity, mainly in patients who were previously responsive t o chemotherapy, This suggests a possible role for gemcitabine as a second-l ine treatment in patients who had a previous response or achieved stable di sease with a platinum-containing regimen, (C) 1999 by American Society of C linical Oncology.