1273O - 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)

Date 09 September 2017
Event ESMO 2017 Congress
Session Presidential Symposium I
Topics Cancer in Adolescents
Non-Small-Cell Lung Cancer, Early Stage
Imaging, Diagnosis and Staging
Lung and other Thoracic Tumours
Surgery and/or Radiotherapy of Cancer
Presenter Virginie Westeel
Citation Annals of Oncology (2017) 28 (suppl_5): v449-v452. 10.1093/annonc/mdx378
Authors V. Westeel1, F. Barlesi2, P. Foucher3, J. Lafitte4, J. Domas5, P. Girard6, J. Tredaniel7, M. Wislez8, P. Dumont9, E. Quoix10, O. Raffy11, D. Braun12, M. Derollez13, F. Goupil14, J. Hermann15, E. Devin16, E. Pichon17, J. Gury18, F. Morin19, P. Souquet20
  • 1Pneumologie, CHRU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 2Multidisciplinary Oncology & Therapeutic Innovations, Aix Marseille University - Assistance Publique des Hôpitaux de Marseille, Marseille/FR
  • 3Pneumologie, CHU Le Bocage (Dijon), 21079 - Dijon/FR
  • 4Pneumologie, CHRU Lille - Hôpital Calmette, Lille/FR
  • 5Pneumologie, Centre Catalan d'Oncologie Clinique St. Pierre, 66000 - Perpignan/FR
  • 6Pneumologie, Institut Mutualiste Montsouris, Paris/FR
  • 7Pneumologie, Hopital St. Joseph, 75014 - Paris/FR
  • 8Pneumologie, APHP, CancerEst, Tenon University Hospital, 75020 - Paris/FR
  • 9Pneumologie, Centre Hospitalier, 2303 - Chauny/FR
  • 10Service De Pneumologie - Pôle De Pathologie Thoracique, NHC, CHU Strasbourg, Strasbourg/FR
  • 11Pneumologie, Centre Hospitalier, Chartres/FR
  • 12Pneumologie, Cabinet, Briey/FR
  • 13Pneumologie, Clinique de Val de Sambre, Maubeuge/FR
  • 14Pneumologie, Centre Hospitalier, Le Mans/FR
  • 15Pneumologie, HPMetz - Hôpital Robert Schuman, Metz/FR
  • 16Pneumologie, CHI EureSeine - Evreux, Evreux/FR
  • 17Pneumologie, CHRU Bretonneau, 37044 - Tours/FR
  • 18Pneumologie, Centre Hospitalier, Vesoul/FR
  • 19Clinical Research Unit, French Cooperative Thoracic Intergroup, 75009 - Paris/FR
  • 20Pneumologie, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR

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.

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.