A phase II trial of single-agent vinflunine as second-line treatment for advanced non-small cell lung cancer (An International Oncology Network Study, #I-05–009)

19033 Background: Single-agent vinflunine has activity in a variety of tumors. This Phase II single-arm study was designed to evaluate the safety and efficacy of vinflunine given every 3 weeks to patients (pts) with advanced NSCLC who have progressed after prior treatment with a platinum-based doublet. The primary endpoint is 1-year survival. Methods: Pts ≥ 18 years with confirmed advanced NSCLC (stage IIIB with malignant pleural effusions or stage IV) who have progressed after receiving a platinum-based doublet as first-line therapy, received vinflunine (320 mg/m2) as a 20-min IV infusion on day 1 of each 21-day cycle. Results: At the time of analysis, 60 pts have received study treatment and 70 pts have been enrolled (of a planned total of 75). Pts characteristics include: male/female, 43/27; median age 65.1 years (range 42–86); ECOG PS 0/1/2, 27/40/3; and Caucasian/Black, 67/3. The median number of cycles was 2 (range 1–22). One-year survival is 25%. Median survival is 6.1 months (95% CI, 3.1 to 8.8). ...