Objective: We conducted a prospective phase II trial of single-agent salvage chemotherapy with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) after failure of chemotherapy and gefitinib to assess the efficacy and toxicity of docetaxel in this setting. Methods: Patients with histologically confirmed NSCLC who were failure of chemotherapy and gefitinib were given docetaxel 75 mg/m2 intravenously for 30 min every 3 weeks until the toxicity was unacceptable or disease progressed. The response evaluation criteria in solid tumors (RECIST) guidelines were used for the evaluation of antitumor activity. Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria version 2.0. Results: In total, 31 patients were enrolled in this phase II trial between February 2004 and December 2006, and 84 cycles (average 2.7 cycles) were given. We observed 4 partial responses (PRs) and 10 stable disease (SD) states in 31 eligible patients. The objective response rate was 12.9%, and the disease control rate was 45.2%. The median survival time (MST) was 10 months (95% CI, 5.05-15.08 months). The 1-year survival rate was 40.6%. The most common toxicities were neutropenia, anemia, and peripheral neuropathy that occurred as follows: 45% of the patients experienced grade 3 or 4 neutropenia, 29% experienced grade 3 anemia, and 25.8% had grade 3 peripheral neuropathy. No patient terminated docetaxel chemotherapy due to toxicity. Conclusion: Docetaxel is beneficial as salvage chemotherapy in patients with advanced NSCLC after failure of cytotoxic agents and gefitinib.
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