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

Herve LeCaer, Jean Yves Delhoume, Pascal Andre Thomas, Henri Berard, Dominique Paillotin, Jean Renaud Barriere, Celine Gimenez, Alain Vergnenegre, Pierre Muller, Pascal Auquier, Maurice Perol
Clinical Lung Cancer 2005, 7 (2): 114-20

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.

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