LUGANO-MADRID – The optimal follow-up protocol for patients with completely resected non-small cell lung cancer (NSCLC) remains elusive after results of the IFCT-0302 trial, presented at the ESMO 2017 Congress in Madrid (1), did not show a difference in overall survival (OS) between patients who received computed tomography (CT) scans as part of their follow-up, and those who did not.
Indeed, the findings suggest regular CT scans, which many guidelines recommend, may not be necessary.
“Because there is no difference between arms, both follow-up protocols are acceptable,” said study investigator Prof. Virginie Westeel, from Centre Hospitalier Régional Universitaire, Hôpital Jean Minjoz in Besançon, France. “A conservative point of view would be to do a yearly CT-scan, which might be of interest over the long-term, however, doing regular scans every six months may be of no value in the first two post-operative years,” she said.
The suggestion is a departure from standard clinical practice, since the majority of medical societies and clinical practice guidelines (2) recommend follow-up visits in which chest CT is considered appropriate every three to six months in the first two years after surgery.
The multicenter study included 1775 patients with completely resected stage I–II-IIIA NSCLC who completed follow-up visits every 6 months for the first two years, and yearly until five years.
Patients were randomised to a control follow-up, that included clinical examination and chest X-ray (CXR), or an experimental follow-up that included the control protocol with the addition of thoraco-abdominal CT-scan plus bronchoscopy (optional for adenocarcinomas).
After a median follow-up of eight years and 10 months, overall survival (OS) was not significantly different between the groups (hazard ratio [HR] 0.95, 95% CI: 0.82-1.09; p=0.37) at a median of 99.7 months in the control arm and 123.6 months in the experimental arm.
Three-year disease-free survival rates were also similar, at 63.3% and 60.2% respectively, as were eight-year OS rates at 51.7% and 54.6%, respectively.
Commenting on the study, ESMO spokesperson Dr. Floriana Morgillo, from the University of Campania Luigi Vanvitelli, Naples, Italy, said that although the study does not demonstrate a significant benefit with CT-based follow-up, the trend towards better survival in the CT arm suggests longer follow-up may eventually reveal a benefit of this approach.
However, in the meantime, she says CT-based surveillance is still an appropriate option because of its potential for impacting second primary cancers. “A significant proportion of patients with early stage NSCLC develop second cancers between the second and fourth year after surgery, and early detection of these with CT-based surveillance beyond two years could allow curative treatment,” Morgillo said, adding that patients must also be informed of the radiation exposure with CT.
Notes to Editors
Please make sure to use the official name of the meeting in your reports: ESMO 2017 Congress
- Abstract 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)’ will be presented by Virginie Westeel during Presidential Symposium I on Saturday, 9 September 2017, 16:30 to 18:00 (CEST) in the Madrid Auditorium.
- ESMO guidelines for Early-Stage and Locally Advanced (Non Metastatic) Non-Small Cell Lung Cancer
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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)
V. Westeel1, F. Barlesi2, P. Foucher3, J.-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.-P. Gury18, F. Morin19, P.-J. Souquet20
1Pneumology, CHRU Jean Minjoz, Besançon/FRANCE, 2Multidisciplinary Oncology & Therapeutic Innovations, Aix Marseille University, Marseille/FRANCE, 3Pneumologie, CHU Le Bocage (Dijon), Dijon/FRANCE, 4Pneumologie, CHRU Lille - Hôpital Calmette, Lille/FRANCE, 5Pneumologie, Centre Catalan d'Oncologie Clinique St. Pierre, Perpignan/FRANCE, 6Pneumologie, Institut Mutualiste Montsouris, Paris/FRANCE, 7Pneumologie, Hopital St. Joseph, Paris/FRANCE, 8Pneumology, Tenon University Hospital, Paris/FRANCE, 9Pneumologie, Centre Hospitalier, Chauny/FRANCE, 10Service De Pneumologie - Pôle De Pathologie Thoracique, NHC, CHU Strasbourg, Strasbourg/FRANCE, 11Pneumologie, Centre Hospitalier, Chartres/FRANCE, 12Pneumologie, Cabinet, Briey/FRANCE, 13Pneumologie, Clinique de Val de Sambre, Maubeuge/FRANCE, 14Pneumologie, Centre Hospitalier, Le Mans/FRANCE, 15Pneumologie, HPMetz - Hôpital Robert Schuman, Metz/FRANCE, 16Pneumologie, CHI EureSeine - Evreux, Evreux/FRANCE, 17Pneumologie, CHRU Bretonneau, Tours/FRANCE, 18Pneumologie, Centre Hospitalier, Vesoul/FRANCE, 19Clinical Research Unit, French Cooperative Thoracic Intergroup, Paris/FRANCE, 20Department Of Pneumology, Centre Hospitalier Lyon Sud, Pierre Bénite/FRANCE
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
Funding: Ministère de la Santé (PHRC), Fondation de France, Laboratoire Lilly
Disclosure: E. Quoix: Non-financial support from AMGEN, non-financial support from Pfizer, personal fees from Abbvie, personal fees and non-financial support from Boehringer Ingelheim, non-financial support from BMS, personal fees from Clovis, personal fees from Lilly
All other authors have declared no conflicts of interest.