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.