Multicenter Phase II Trial of Carboplatin/Vinorelbine in Elderly Patients with Advanced Non-Small-Cell Lung Cancer-Efficacy and Impact on Quality of Life: Groupe Français de Pneumo-Cancérologie Study 9902

BACKGROUND: Approximately 30% of lung cancer cases are diagnosed in patients > 70 years of age. Standard chemotherapy regimens are generally considered too toxic for elderly patients. We conducted a multicenter phase II trial to determine the efficacy and safety of carboplatin combined with vinorelbine every 4 weeks as first-line treatment for advanced non-small-cell lung cancer (NSCLC) in elderly patients. PATIENTS AND METHODS: Patients were eligible if they were aged ≤ 70 years, had stage IIIB (with pleural effusion) or stage IV NSCLC, had a performance status of 0/1, had not previously received chemotherapy, and had normal organ function. Forty patients (31 men and 9 women) were enrolled and received 3-5 courses of treatment. Median age was 72 years (range, 70-82 years). Eighty percent of patients had stage IV NSCLC, with squamous cell (n = 21), adenocarcinoma (n = 12), and undifferentiated (n = 7) histologies. RESULTS: Forty patients were assessable for toxicity and 32 for treatment response. Among these 32 patients, 8 had a partial response (intent-to-treat response rate, 20%), and 10 (25%) had stable disease. The median survival was 7.8 months (range, 4-11.6 months). The 1- and 2-year survival rates were 25% and 7%, respectively; median time to progression was 4.3 months (range, 0.2-13.8 months). Grade 3/4 neutropenia was seen in 27 patients (68%), and grade 3/4 anemia was seen in 5 patients (13%). One patient died of febrile neutropenia during treatment. The main nonhematologic adverse effect was fatigue (grade 3/4 in 18% of patients). CONCLUSION: Carboplatin/vinorelbine is well tolerated by elderly patients with extensive-stage NSCLC. Efficacy is low but similar to that of other treatments used in this setting.