Final results of a trial comparing two neoadjuvant chemotherapy (CT) regimens followed by surgery in patients with resectable non-small cell lung cancer (NSCLC): A phase II randomized study by the European Lung Cancer Working Party

7055 Background: (Neo)adjuvant cisplatin-based CT demonstrated its activity in improving survival in resectable NSCLC. We aimed to determine if a combination of cisplatin with second-generation drugs (GNP) and a standard neoadjuvant chemotherapy with first-generation drugs (MIP) can be performed in patients with initially resectable stage I-IIIA NSCLC, without reducing the resectability rate. Final results are presented. Methods: Patients with previously untreated pathologically proven stage I-IIIA resectable NSCLC, Karnofsky performance status ≥ 60, adequate haematological, hepatic, renal, lung and cardiac functions were eligible. After central randomisation, patients received three courses of MIP (ifosfamide 3g/m2, mitomycine 6 mg/m2, cisplatin 50 mg/m2) or GNP (gemcitabine 1g/m2 D1-8, vinorelbine 25 mg/m2 D1-8, cisplatin 50 mg/m2). The conclusion of feasibility of each regimen will be drawn if, at least, 50 patients per arm within a sample size of 67 can be completely resected (α 5%, β 20%). Results: F...