Cisplatin plus vinorelbine as induction chemotherapy followed by surgery in the treatment of stage IIIB non-small cell lung cancer. Final results of a multicenter phase II study.

BACKGROUND: The combination of cisplatin and vinorelbine has been shown to be effective in patients with advanced non-small cell lung cancer (NSCLC). Based on these data, we planned to treat patients with stage IIIB NSCLC without malignant pleural effusion and/or metastatic supraclavicular lymph nodes, in order to study the potential effectiveness of this association as neoadjuvant treatment. MATERIALS AND METHODS: Thirty patients entered into the study and were treated preoperatively with cisplatin 120 mg/m2 given on day 1 and vinorelbine 30 mg/m2 given on days 1 and 8, recycled every 3 weeks for a maximum of 3 cycles. The main characteristics of patients were: male/female 23/7, median age 61 years, performance status 0/1/2, 8/17/5. Only patients who achieved an objective response underwent surgery. RESULTS: A total of 82 (91.1%) cycles were administered with moderate toxicity: WHO grade (G) 2 and 3 neutropenia occurred in 20 (66.6%) patients, G 3 anaemia occurred in 4 (13.3%), G 3 nausea/vomiting in 20 (66.6%) and G 1-2 renal toxicity in 2 (6.6%). Eighteen (60%; exact 95% confidence limits, 40.6% to 77.3%) patients achieved a partial response and 14 (46.6%) underwent surgery. Complete resection (R0) was achieved in 11 (36.6% of all patients) and pathological complete resection in 5 (16.6%). No postoperative pulmonary complications were reported. The median survival for all patients was 25.5 (exact 95% confidence limits, 13 to 39) months. The median progression-free survival in responsive patients was 27 (exact 95% confidence limits, 13 to 33) months. CONCLUSION: The combination of cisplatin and vinorelbine is effective and safe as a neoadjuvant therapy in stage IIIB NSCLC, showing a high response rate (60%) and amenability to surgery.