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)

      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.
      Clinical trial identification: NCT00198341
      Legal entity responsible for the study: Intergroupe Francophone de Cancérologie Thoracique (IFCT)
      Funding: Ministère de la Santé (PHRC), Fondation de France, Laboratoire Lilly
      Disclosure: E. Quoix: Non-financial support from AMGEN, Pfizer, BMS. Personal fees from Abbvie, Clovis and Lilly. Personal fees and non-financial support from Boehringer Ingelheim. All other authors have declared no conflicts of interest.