A Adenis1, J Bennouna2, P L Etienne3, E Bogart4, E Francois5, M P Galais6, M Ben Abdelghani7, P Michel8, J P Metges9, L Dahan10, T Conroy11, F Ghiringhelli12, A Drouillard13, F El Hajbi14, E Samalin15, S Hiret2, S Delaine-Clisant16, C Mariette17, N Penel18, G Piessen17, M C Le Deley19. 1. Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France; Département d'Oncologie Médicale, Institut Régional du Cancer de Montpellier, Montpellier, France; FREnch EsoGastric Tumor (FREGAT) Working Group, Lille, France. Electronic address: antoine.adenis@icm.unicancer.fr. 2. Département d'Oncologie Médicale, Institut de Cancérologie de l'Ouest, Saint-Herblain, France. 3. Centre Armoricain Radiothérapie Imagerie Oncologie, Hôpital Privé des Côtes d'Armor, Plérin, France. 4. Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France. 5. Département d'Oncologie Médicale, Centre Antoine Lacassagne, Nice, France. 6. Département d'Oncologie Médicale, Centre Francois Baclesse, Caen, France. 7. Département d'Oncologie Médicale, Centre Paul Strauss, Strasbourg, France. 8. Service d'Hépato-Gastroenterologie, Charles Nicolle University Hospital, Rouen, France. 9. Institut de Cancérologie et d'Hématologie, Morvan University Hospital, Brest, France. 10. Service d'Oncologie Digestive et d'Hépato-Gastroentrologie, La Timone University Hospital, Marseille, France. 11. Département d'Oncologie Médicale, Institut de Cancérologie de Lorraine, Université de Lorraine, Vandœuvre-lès-Nancy, France. 12. Département d'Oncologie Médicale, Centre Georges-Francois Leclerc, Dijon, France. 13. Service d'Hépato-Gastroenterologie, Francois Mitterrand University Hospital, Dijon. 14. Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France. 15. Département d'Oncologie Médicale, Institut Régional du Cancer de Montpellier, Montpellier, France. 16. Département d'Oncologie Médicale, Institut Régional du Cancer de Montpellier, Montpellier, France; Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France. 17. FREnch EsoGastric Tumor (FREGAT) Working Group, Lille, France; Univ. Lille, Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France. 18. Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France; Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France. 19. Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France; CESP, INSERM, Paris-Sud, Paris-Saclay University, 94805 Villejuif, France.
Abstract
PURPOSE: The role of chemotherapy has not been established in the treatment of metastatic squamous cell oesophageal cancer (mESCC). PATIENTS AND METHODS: E-DIS is a discontinuation trial, aimed at estimating efficacy, quality of life and safety of chemotherapy continuation (CT-CONT) in patients with mESCC who are free from progression after a selection phase of chemotherapy. The primary end-point was overall survival. RESULTS:Sixty-seven patients were randomised. The 9-month survival rate was 50% (85% confidence interval [CI]: 37-62%) and 48% (85% CI: 35-60%) in the CT-CONT arm and in the chemotherapy discontinuation (CT-DISC) arm, respectively. The time until definitive deterioration of the global health status (European Organisation for Research and Treatment of Cancer [EORTC] core quality of life questionnaire) was 6.6 months (95% CI: 3.3-12.4) for the CT-CONT arm and 4.2 months (95% CI: 2.9-6.3) for the CT-DISC arm, with a hazard ratio (HRCT-DISC/CT-CONT) = 1.44 (95% CI: 0.82-2.53). We observed a beneficial trend in favour of CT-CONT (HR > 1) for most dimensions, including an improvement for three dimensions (dysphagia, eating and oesophageal pain) of the EORTC Oesophageal Cancer Module QLQ-OES18. CONCLUSION:CT-CONT provides an overall survival rate that is similar to CT-DISC. E-DIS trial provides valuable data to support shared decision-making between physicians and patients regarding CT-CONT/DISC.
RCT Entities:
PURPOSE: The role of chemotherapy has not been established in the treatment of metastatic squamous cell oesophageal cancer (mESCC). PATIENTS AND METHODS: E-DIS is a discontinuation trial, aimed at estimating efficacy, quality of life and safety of chemotherapy continuation (CT-CONT) in patients with mESCC who are free from progression after a selection phase of chemotherapy. The primary end-point was overall survival. RESULTS: Sixty-seven patients were randomised. The 9-month survival rate was 50% (85% confidence interval [CI]: 37-62%) and 48% (85% CI: 35-60%) in the CT-CONT arm and in the chemotherapy discontinuation (CT-DISC) arm, respectively. The time until definitive deterioration of the global health status (European Organisation for Research and Treatment of Cancer [EORTC] core quality of life questionnaire) was 6.6 months (95% CI: 3.3-12.4) for the CT-CONT arm and 4.2 months (95% CI: 2.9-6.3) for the CT-DISC arm, with a hazard ratio (HRCT-DISC/CT-CONT) = 1.44 (95% CI: 0.82-2.53). We observed a beneficial trend in favour of CT-CONT (HR > 1) for most dimensions, including an improvement for three dimensions (dysphagia, eating and oesophageal pain) of the EORTC Oesophageal Cancer Module QLQ-OES18. CONCLUSION:CT-CONT provides an overall survival rate that is similar to CT-DISC. E-DIS trial provides valuable data to support shared decision-making between physicians and patients regarding CT-CONT/DISC.