RANDOMIZED TRIAL COMPARING POSTOPERATIVE CHEMOTHERAPY WITH VINDESINE AND CISPLATIN PLUS THORACIC IRRADIATION WITH IRRADIATION ALONE IN STAGE-III (N2) NONSMALL CELL LUNG-CANCER

This prospective randomized trial was performed to determine whether p ostoperative chemotherapy with vindesine and cisplatin could lengthen time to progression and overall survival in stage III (Tl-3N2M0) non-s mall cell lung cancer (NSCLC) patients. Seventy-two patients were ente red; 36 were randomized to receive chemotherapy. Patients were stratif ied by extent of resection (complete vs. incomplete) and histology (sq uamous vs. nonsquamous). All had surgery and mediastinal irradiation 6 -7 weeks post-thoracotomy. Incompletely resected patients had intraope rative I-125 and/or Ir-192 implantation. Vindesine (3 Mg/M2) weekly x 5, then every 2 weeks x 8, and cisplatin (120 Mg/M2) days 1, 29, 71, 1 13 were planned for those randomized to chemotherapy. No difference in time to progression (median 9.2 months for radiation + chemotherapy v s. 9.0 months for radiation, P = 0.35) or overall survival (16.3 month s for radiation + chemotherapy vs. 19.1 months for radiation, P = 0.42 ) was found. Postoperative vindesine and cisplatin did not prolong tim e to progression or survival in this population of stage III NSCLC. (C ) 1994 Wiley-Liss, Inc.