Prospective phase II trial of a combination of gemcitabine and UFT as first-line treatment in elderly patients with advanced non-small cell lung cancer

Background: The standard regimen in elderly patients with non-small-cell lung cancer (NSCLC) is still uncertain. Gemcitabine is one of the most widely used drugs for the treatment of NSCLC, and several phase II trials specifically designed for elderly patients with advanced NSCLC have confirmed the role of gemcitabine in this setting. In addition, oral uracil-tegafur (UFT) was associated with a survival advantage in the adjuvant setting. Therefore, we performed a phase II study using the combination of gemcitabine and UFT as first-line therapy in elderly patients with advanced NSCLC. Methods: Chemotherapy-naive, elderly (>= 70 years) patients who had histologically or cytologically confirmed with stage IIIB or IV NSCLC with a performance status of 1-2 were enrolled. Patients received gemcitabine (1250 mg/m(2) on days 1 and 8, respectively) and UFT (400 mg/day on days 1-14) every 3 weeks for up to four cycles. Patients who had not progressed after four cycles continued UFT monotherapy until progression. Primary endpoint was overall response rate and secondary endpoints were overall survival, time to progression and safety profiles. Results: Between March 2008 and November 2010, 48 patients were enrolled. The median age was 74.5 years (range: 70-84 years), and there were 29 males. The performance status was 1 in 41 and 2 in 7 patients. Thirty-one (64.6%) patients were stage IV and seventeen (35.4%) patients were stage IIIB. Thirty-patients (62.5%) completed four cycles of chemotherapy. Response was evaluated in 44 patients. Partial response was achieved in twelve (25.0%) patients and stable disease in 23 (47.9%) patients. Disease control rate was 72.9%. The median survival time was 6.1 months (95% confidence interval [CI]; 5.1-7.0 months), the 1-year survival rate was 29.1% and the median time to progression was 4.6 months (95% CI; 3.7-5.5 months). Toxicities were mild and mostly hematological adverse events. Grade 3/4 neutropenia occurred in 8.3% of patients and one patients experienced febrile neutropenia. Grade 3/4 anemia and thrombocytopenia occurred in 2.1% and 2.1% of patients, respectively. Non-hematological toxicities were tolerable. Conclusions: The combination of gemcitabine and UFT was effective in disease control and well tolerated first-line regimen in elderly patients with advanced NSCLC. (c) 2011 Elsevier Ireland Ltd. All rights reserved.