A randomized trial comparing adjuvant chemotherapy versus surgery alone for completely resected pN2 non-small cell...

The purpose of this study was to evaluate the efficacy of adjuvant chemotherapy with three courses of cisplatin and vindesine, in comparison to observation only, for N2 non-small cell lung cancer that had been completely resected. Patients with pathologically demonstrated mediastinal lymph node metastasis (N2), who had undergone complete resection, were randomized to observation or adjuvant chemotherapy (cisplatin 80 mg/m2 on day 1; vindesine 3 mg/m2 on days 1 and 8: x3 courses). Cycles started within 6 weeks after complete resection and were repeated every 4 weeks. This trial was terminated before accumulation of the planned numbers for registration because of a slow accrual rate. A total of 119 patients were randomized (59 patients in the adjuvant arm and 60 with surgery alone). The median survival was 36 months for both groups. Postoperative cisplatin with vindesine chemotherapy was not shown to be efficacious in cases of completely resected N2 non-small cell lung cancer in this setting of timing, dose and agents studied.