Continuation versus discontinuation of first-line chemotherapy in patients with metastatic squamous cell oesophageal cancer: A randomised phase II trial (E-DIS)
- Others:
- Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM) ; CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)
- Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille) ; Université de Lille-UNICANCER
- Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO) ; UNICANCER
- Hôpital Privé des Côtes d'Armor (HPCA)
- Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL) ; UNICANCER-Université Côte d'Azur (UCA)
- Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC) ; Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)
- CRLCC Paul Strauss
- Service d'Hépato-Gastroentérologie [CHU Rouen] ; Hôpital Charles Nicolle [Rouen]-CHU Rouen ; Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN) ; Normandie Université (NU)
- Hôpital Morvan - CHRU de Brest (CHU - BREST )
- Service d'oncologie digestive et hépato-gastro-entérologie [Hôpital de la Timone - APHM] ; Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE)
- Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL) ; UNICANCER
- Département d'oncologie médicale [Centre Georges-François Leclerc] ; Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL) ; UNICANCER-UNICANCER
- Service d'Hépato-Gastro-Entérologie (CHU de Dijon) ; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)
- CRLCC Val d'Aurelle - Paul Lamarque
- Hôpital Claude Huriez [Lille] ; CHU Lille
- Centre de recherche en épidémiologie et santé des populations (CESP) ; Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)
Description
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.
Abstract
International audience
Additional details
- URL
- https://hal.umontpellier.fr/hal-02418932
- URN
- urn:oai:HAL:hal-02418932v1
- Origin repository
- UNICA