Phase II Study of Carboplatin–Paclitaxel Combination Chemotherapy in Elderly Patients with Advanced Non-small Cell Lung Cancer

Abstract

Background: More than 30% of cases of non-small cell lung cancer (NSCLC) arise in patients aged ≥70 years. The efficacy and safety of carboplatin–paclitaxel combination chemotherapy in elderly patients with advanced NSCLC were evaluated in a phase II trial. Methods: Twenty-five patients aged ≥70 years (median, 76; range, 70–83) with chemotherapy-naïve advanced NSCLC were enrolled between January 2001 and July 2003. Additional criteria included the presence of measurable lesions, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Patients received carboplatin at an area under the curve of 5 mg/ml/min and paclitaxel at 180 mg/m² on the first day of consecutive 3 week periods. Results: The patients included four with stage IIIB, 19 with stage IV and two with recurrent disease. The median number of treatment cycles was three (range, 1–4). One complete response and six partial responses, yielding an objective response rate of 28%, were obtained. The median survival time was 12.3 months and the 1-year survival rate was 52%. Hematological toxicities of grade 3 or 4 included leukopenia (40%), neutropenia (68%) and anemia (4%). Non-hematological toxicities of grade 3 included arthralgia–myalgia (16%) and neuropathy (12%). The objective response rate for patients aged ≥75 years (n = 15) was 26%, and no evidence of excessive toxicity in these patients was apparent compared with those aged Conclusion: The combination carboplatin–paclitaxel at these doses is a feasible treatment option with a favorable toxicity profile for fit elderly patients with advanced NSCLC.