Author(s): Prof Virginie Westeel, MD1;Pascal Foucher, MD2;Prof Arnaud Scherpereel, MD3;Jean Domas, MD4;Jean Trédaniel, MD5;Prof Marie Wislez, MD6;Patrick Dumont, MD7;Prof Elisabeth Quoix, MD8;Olivier Raffy, MD9;Denis Braun, MD10;Marc Derollez, MD11;François Goupil, MD12;Jacques Hermann, MD13;Etienne Devin, MD14;Hubert Barbieux, MD15;Eric Pichon, MD16;Didier Debieuvre, MD17;Gervais Ozenne, MD18;Prof Jean-François Muir, MD18;Stéphanie Dehette, MD19;Jérôme Virally, MD20;Michel Grivaux, MD21;Prof François Lebargy, MD22;Prof Pierre-Jean Souquet, MD23;Faraj Al Freijat, MD24;Prof Nicolas Girard, MD25;Emmanuel Courau, MD26;Reza Azarian, MD27;Michel Farny, MD28;Jean-Paul Duhamel, MD29;Alexandra Langlais, MSc30;Franck Morin, MSc30;Bernard Milleron, MD31;Prof Gérard Zalcman, MD32;Prof Fabrice Barlesi, MD33
Even after resection of early-stage non-small-cell lung cancer (NSCLC), patients have a high risk of developing recurrence and second primary lung cancer. We aimed to assess efficacy of a follow-up approach including clinic visits, chest x-rays, chest CT scans, and fibre-optic bronchoscopy versus clinical visits and chest x-rays after surgery for resectable NSCLC.
In this multicentre, open-label, randomised, phase 3 trial (IFCT-0302), patients aged 18 years or older and after complete resection of pathological stage I–IIIA NSCLC according to the sixth edition of the TNM classification were enrolled within 8 weeks of resection from 122 hospitals and tertiary centres in France. Patients were randomly assigned (1:1) to CT-based follow-up (clinic visits, chest x-rays, thoraco-abdominal CT scans, and fibre-optic bronchoscopy for non-adenocarcinoma histology) or minimal follow-up (visits and chest x-rays) after surgery for NSCLC, by means of a computer-generated sequence using the minimisation method. Procedures were repeated every 6 months for the first 2 years and yearly until 5 years. The primary endpoint was overall survival analysed in the intention-to-treat population. Secondary endpoints, also analysed in the intention-to-treat population, included disease-free survival. This trial is registered with ClinicalTrials.gov, NCT00198341, and is active, but not enrolling.
Between Jan 3, 2005, and Nov 30, 2012, 1775 patients were enrolled and randomly assigned to a follow-up group (888 patients to the minimal follow-up group; 887 patients to the CT-based follow-up group). Median overall survival was not significantly different between follow-up groups (8·5 years [95% CI 7·4–9·6] in the minimal follow-up group vs 10·3 years [8·1–not reached] in the CT-based follow-up group; adjusted hazard ratio [HR] 0·95, 95% CI 0·83–1·10; log-rank p=0·49). Disease-free survival was not significantly different between follow-up groups (median not reached [95% CI not estimable–not estimable] in the minimal follow-up group vs 4·9 [4·3–not reached] in the CT-based follow-up group; adjusted HR 1·14, 95% CI 0·99–1·30; log-rank p=0·063). Recurrence was detected in 246 (27·7%) of 888 patients in the minimal follow-up group and in 289 (32·6%) patients of 887 in the CT-based follow-up group. Second primary lung cancer was diagnosed in 27 (3·0%) patients in the minimal follow-up group and 40 patients (4·5%) in the CT-based follow-up group. No serious adverse events related to the trial procedures were reported.
The addition of thoracic CT scans during follow-up, which included clinic visits and chest x-rays after surgery, did not result in longer survival among patients with NSCLC. However, it did enable the detection of more cases of early recurrence and second primary lung cancer, which are more amenable to curative-intent treatment, supporting the use of CT-based follow-up, especially in countries where lung cancer screening is already implemented, alongside with other supportive measures.
French Health Ministry, French National Cancer Institute, Weisbrem-Benenson Foundation, La Ligue Nationale Contre Le Cancer, and Lilly Oncology.
Author Affiliations1Department of Pneumology, University Hospital of Besançon, INSERM UMR1098, Université de Bourgogne-Franche-Comté, Besançon, France;2Department of Pneumology, University Hospital Bocage, Dijon, France;3University of Lille, CHU Lille, Thoracic Oncology Department, CNRS, Inserm, Institut Pasteur de Lille, UMR9020—UMR-S 1277—Canther, Lille, France ;4Department of Pneumology, Institut Curie Montsouris, Paris, France;5Department of Pneumology, Saint Joseph Hospital, Paris, France;6Pneumology and Thoracic Oncology, Hôpital Tenon, Paris, France;7Pneumology Department, Hospital Centre – Chauny, Chauny, France;8Pneumology, Nouvel Hôpital Civil – Hôpitaux Universitaires de Strasbourg, Inserm UMR_S 1113, IRFAC, Strasbourg University, Strasbourg, France;9Department of Pneumology, Hospital of Chartres, Chartres, France;10Department of Pneumology, Maillot Hospital, Briey, France;11Department of Pneumology, Maubeuge Hospital, Maubeuge, France;12Department of Pneumology, University Hospital of Le Mans, Le Mans, France;13Department of Pneumology, Hospital Robert Schuman, Metz, France;14Department of Pneumology, Hospital of Evreux, Evreux, France;15Department of Oncology, Hospital of Auxerre, Auxerre, France;16Department of Pneumology, University Hospital of Tours, Tours, France;17Department of Pneumology, GHRMSA, Mulhouse, France ;18Department of Pneumology, University Hospital Rouen Bois-Guillaume, Rouen, France;19Department of Pneumology, Hospital of Compiegne, Compiegne, France;20Department of Pneumology, Hospital of Aulnay-Sous-Bois, Aulnay-Sous-Bois, France;21Department of Pneumology, Hospital of Meaux, Meaux, France;22Department of Pneumology, University Hospital of Reims, Reims, France;23Department of Pneumology, Hospital Lyon Sud, Lyon, France;24Department of Pneumology, Hospital of Belfort, Belfort, France;25Pneumology, Hôpital Cardio-Vasculaire and Pneumologique Louis Pradel, Bron, France;26Department of Pneumology, Clinique Pasteur, Toulouse, France;27Department of Pneumology, Hospital of Versailles, Versailles, France;28Pneumology Department, Hospital of Cahors, Cahors, France;29Department of Pneumology, Hospital of Le Havre, Le Havre, France;30Intergroupe Francophone de Cancérologie Thoracique, Paris, France;31Pneumology and Thoracic Oncology, Hôpital Tenon, Paris, France;32Université Paris Cité Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Institut du Cancer, Nord Paris, France;33Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, CNRS, INSERM, CRCM, APHM, Campus Timone, CHU NORD, Marseille, France