Results of the phase III IFCT-0302 trial assessing minimal versus CT-scan-based follow-up for completely resected non-small cell lung cancer (NSCLC)

Abstract

Background: Several guidelines recommend a follow‐up based on clinic visits and chest CT‐scans for completely resected NSCLC. However, evidence to support these recommendations is poor, in the absence of randomized data. The IFCT‐0302 trial is a randomized multicenter trial which compared 2 follow‐up programs for completely resected stage pI, II, IIIA and T4 (pulmonary nodules in the same lobe) N0‐2 NSCLC (TNM 6th edition). Methods: In the control arm (arm 1), follow‐up consisted of clinical examination and Chest X‐ray (CXR). In the experimental arm (arm 2), patients underwent clinical examination, CXR, thoraco‐abdominal CT‐scan (CT) plus bronchoscopy (optional for adenocarcinomas). In both arms, procedures were repeated every 6 months after randomization during the first 2 years, and yearly until 5 years. Supplementary procedures were allowed in case of symptoms. The primary endpoint was overall survival (OS). Results: Between January 2005 and November 2012, 1775 patients were randomized (arm 1: 888; arm 2: 887). Patient characteristics were well‐balanced between the two arms: males 76.3%, median age 63 years (range: 34‐88), squamous and large cell carcinomas 39.5%, stage I 68.1%, stage II 13.7%, stage III 18.3%, lobectomy or bilobectomy 86.6%, pre‐ and/or post‐operative radiotherapy 8.7%, and pre‐ and/or post‐operative chemotherapy 45%. Median follow‐up was 8.7 yrs (95% CI: 8.5‐9). OS was not significantly different between arms (HR=0.92, 95% CI: 0.8‐1.07; p=0.27). Median OS was 8.2 yrs (95% CI: 7.4‐9.6) and 10.3 yrs (95% CI: 8.5‐not reached) in arms 1 and 2, respectively. Three‐year disease‐free survival rates were 63.3% (95%CI: 60.2%‐66.5%), and 60.2% (95% CI: 57.0%‐63.4%), respectively. Eight‐year OS rates were 51.1% (95% CI: 47.2%‐55.1%) and 55.6% (95% CI: 51.7%‐59.4%) respectively. Conclusions: The IFCT‐0302 trial is the first randomized study of follow‐up in resected NSCLC. The primary endpoint was not met. A longer follow‐up is necessary not to miss a potential long‐term OS benefit of CT‐scan‐based surveillance.