Objective: High-dose epirubicin was shown to be effective in the treatment of inoperable non-small cell lung cancer (NSCLC). Paclitaxel is synergistic to a conventional dose of anthracyclines in the treatment of advanced cancer. A phase II study was designed to test the effectiveness of combining paclitaxel with a conventional dose of epirubicin in inoperable NSCLC patients. Methods: Eligibility criteria included inoperable stage IIIB or IV NSCLC patients, Eastern Cooperative Oncology Group performance status of 0-2, measurable or evaluable disease and adequate organ function. Epirubicin 70 mg/m(2) intravenous infusion for 15 min was given on day 1. Paclitaxel 175 mg/m(2) intravenous infusion for 3 h was given on day 2. Cycles were repeated every 21 days. Tumor response was evaluated every two cycles. Patients received treatment until disease progression, unacceptable toxicity or stable disease after cycle 6. Results:Thirty-eight patients received a total of 185 cycles (median 6 cycles). Seventeen patients responded to treatment (response rate 44.7%). Twenty-six (68%) patients received second-line chemotherapy. All patients were followed until their death. Median survival was 11.9 months (95% confidence interval 9.0-14.9 months). Median time-to-treatment-failure was 4.6 months. Conclusion: Conventional dose epirubicin plus paclitaxel is effective as a first-line treatment for inoperable NSCLC patients.
