ANITA: Phase III adjuvant vinorelbine (N) and cisplatin (P) versus observation (OBS) in completely resected (stage I-III) non-small-cell lung cancer (NSCLC) patients (pts): Final results after 70-month median follow-up. On behalf of the Adjuvant Navelbine International Trialist Association

7013 Background: Adjuvant chemotherapy demonstrated a 5–15% benefit in 5-year survival in the IALT, JBR10 and CALGB9633 trials. However, other trials were negative (ALPI, ECOG 3590) and the role of chemotherapy for each disease stage has not yet been completely clarified. The randomized, prospective phase III trial ANITA compared the effectiveness of adjuvant NP versus OBS in early NSCLC. Methods: Completely resected pts were randomized to receive adjuvant NP (N 30 mg/m2/week, 16 administrations plus P 100 mg/m2 d1 q4 weeks for 4 cycles) or OBS. Eligibility criteria included histologically proven NSCLC, age 18–75 years, post-operative stage I (T2N0), II or IIIA. Radiotherapy policy was predetermined by each center. Study design: open, multicenter, randomized (1:1), stratified by center, stage and histology. Main endpoint: overall survival. Assuming 5% alfa error and 90% power to demonstrate a 10% improvement in survival at 2 years, 400 patients per arm had to be included. Results: 840 patients (NP 407; OB...