An open multicenter phase II trial of weekly docetaxel for advanced-stage non-small-cell lung cancer in elderly patients with significant comorbidity and/or poor performance status: The GFPC 02-02b study.

CONTEXT: The objective of this study was to evaluate the feasibility and activity of weekly docetaxel monotherapy in frail elderly patients with advanced-stage non-small-cell lung cancer, selected on the basis of their precise age, general condition, and number of comorbid disorders (Charlson score). METHODS: Analysis of the response rate, toxicity, quality of life, median survival and 1-year survival rates after 1-3 six-week cycles of docetaxel 30mg/m(2) weekly. RESULTS: Fifty patients were enrolled and 42 were assessable. Five patients (10%, [3.7-22.6]) had objective responses, 14 (28%, [16.9-41.6]) had stable disease, and 23 (46%, [32.6-52.8]) progressed. The main grade 3-4 toxicity was fatigue (30%). Quality of life remained stable during treatment. The median survival time was 4.3 months, and the 1-year survival rate was 21.8%. CONCLUSION: In frail elderly patients selected on the basis of their age, general condition and comorbidity, weekly docetaxel monotherapy has acceptable toxicity and does not negatively affect quality of life. In contrast, it has only moderate activity.

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 Francais de Pneumo-Cancerologie 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 >OR= 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.