Phase II study of paclitaxel and epirubicin as first-line treatment in patients with metastatic nonsmall cell lung carcinoma

BACKGROUND, The combination of paclitaxel and epirubicin has shown a favorable interaction in patients with advanced breast carcinoma. Therefore the efficacy and toxicity of this regimen was evaluated in a Phase II study of patients with metastatic nonsmall cell lung carcinoma (NSCLC). METHODS. Thirty-two chemotherapy-naive patients with AJCC Stage IV NSCLC and an Eastern Cooperative Oncology Group performance status of 0-1 were entered into the study. Patients received epirubicin, 90 mg/m(2), followed by paclitaxel, 175 mg/m(2) by 3-hour infusion, on Day 1. The treatment was repeated every 3 weeks. Granulocyte-colony stimulating factor (G-CSF) was not used routinely. RESULTS, A total of 116 treatment cycles was delivered. All patients could be assessed for response, toxicity, and survival. There were 16 partial responses and no complete responses, giving rise to an overall response rate of 50% (95% confidence interval, 31.9-68.1%). The median time to progression in responders was 7 months. The median survival was 8 months, and the 1-year survival rate was 37%. World Health Organization Grade 4 neutropenia occurred in 69% of patients, but could be managed easily with G-CSF, which was used in 35% of cycles. Cumulative peripheral neuropathy was the main nonhematologic toxicity and was observed in 7 of 8 patients who received 6 treatment courses (Grade 2-3 in 3 cases) and in 6 of 11 patients who received 4 cycles (Grade 2 in 2 patients). One patient died shortly after the first course of chemotherapy from a ventricular arrhythmia. CONCLUSIONS. The combination of paclitaxel and epirubicin was found to be effective and well tolerated in chemotherapy-naive patients with metastatic NSCLC and warrants further evaluation in a multicenter trial of a larger number of patients. Careful cardiac evaluation before treatment is indicated. (C) 2000 American Cancer Society.