Thierry Le Chevalier (MD)     ASCO: 2003  (6) Session: Plenary Session (Scientific Program)

One third of NSCLC pts present with operable disease and this might increase with screening programs. The 1995 meta-analysis on adjuvant CT in NSCLC suggested a 5% improvement of survival at 5 years. On this rationale, IALT was designed to evaluate the impact on survival of 3 to 4 cycles of adjuvant cisplatin-based CT after complete resection of NSCLC. Each center predetermined cisplatin dose (total 300-400 mg/m2), combined drug (etoposide or a vinca-alkaloid) and radiotherapy (RT) policy. Tests were two-sided. Analyses were adjusted by center, surgery and pathological stage. Between 1995 and 2000, 1867 pts were randomized from 148 centers in 33 countries. On September 1st 2002, median follow-up was 56 months and <2% of pts had no follow-up in 2002. Median age was 59 yrs. There were 80% males; 47% squamous cell carcinoma, 40% adenocarcinoma, 12% other subtypes; 64% lobectomies, 35% pneumonectomies, 1% segmentectomies; 36% pStage I, 25% pStage II, 39% pStage III. There were 935 pts allocated to CT and 67% received at least 300 mg/m2 of cisplatin. The drug combined with cisplatin was etoposide (56%), vinorelbine (27%), vinblastine (11%) and vindesine (6%). There were 932 pts in the control arm.

Overall survival was significantly different between the 2 arms: 2 and 5-yr survival rates were 70% and 45 % in the CT arm vs 67% and 40% in the control arm respectively. Disease-free survival was also significantly different: 61 % and 39% in the CT arm vs 55% and 34% in the control arm at 2 and 5 yrs respectively. No significant interaction was observed with age, gender, PS, type of surgery, pStage, histology, cisplatin dose, combined drug, RT. In the CT arm, 23% of pts had at least one grade IV toxicity, mainly neutropenia (18%) and 7 (0.8%) died of CT toxicity. The present trial supports the use of adjuvant CT in resected NSCLC. It opens a large field of new questions including drugs, timing and biological considerations