Many lung cancers are diagnosed in patients over 70 years of age, but there are little published data on chemotherapy in elderly patients. We therefore activated a phase II study in order to assess the tolerance and activity of carboplatin (80 mg/m(2)) and vinorelbine (25 mg/m(2)) administered weekly in patients aged greater than or equal to 70 with advanced non-small cell lung cancer. Twenty-five patients (22 males, 3 females; performance status ECOG, 0-2; median age, 75 years, range 70-85) were included in the study and are assessable for response and side effects. A total of 162 cycles of therapy have been delivered (median/patient, 6 cycles). Seven partial remissions (28%; 95% confidence interval 5-36%), 8 disease stabilizations, and 10 progressions have been observed. Median time to disease progression was 4 months, and median survival was 5 months (range, 2-25+). Grade III/IV toxicity consisted mainly of leukopenia and neutropenia observed respectively in 5 and 7 patients. In conclusion, the schedule demonstrated activity and good tolerability in this subset of patients. Elderly patients with good performance status and adequate organ function can be safely treated with systemic chemotherapy.

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