Continuation versus discontinuation of first-line chemotherapy in patients with metastatic squamous cell oesophageal cancer: A randomised phase II trial (E-DIS).


Journal

European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373

Informations de publication

Date de publication:
04 2019
Historique:
received: 09 10 2018
revised: 17 01 2019
accepted: 18 01 2019
pubmed: 25 2 2019
medline: 27 5 2020
entrez: 25 2 2019
Statut: ppublish

Résumé

The role of chemotherapy has not been established in the treatment of metastatic squamous cell oesophageal cancer (mESCC). 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. 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 (HR 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.

Identifiants

pubmed: 30798084
pii: S0959-8049(19)30037-1
doi: 10.1016/j.ejca.2019.01.016
pii:
doi:

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

12-20

Informations de copyright

Copyright © 2019 Elsevier Ltd. All rights reserved.

Auteurs

A Adenis (A)

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.

J Bennouna (J)

Département d'Oncologie Médicale, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.

P L Etienne (PL)

Centre Armoricain Radiothérapie Imagerie Oncologie, Hôpital Privé des Côtes d'Armor, Plérin, France.

E Bogart (E)

Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France.

E Francois (E)

Département d'Oncologie Médicale, Centre Antoine Lacassagne, Nice, France.

M P Galais (MP)

Département d'Oncologie Médicale, Centre Francois Baclesse, Caen, France.

M Ben Abdelghani (M)

Département d'Oncologie Médicale, Centre Paul Strauss, Strasbourg, France.

P Michel (P)

Service d'Hépato-Gastroenterologie, Charles Nicolle University Hospital, Rouen, France.

J P Metges (JP)

Institut de Cancérologie et d'Hématologie, Morvan University Hospital, Brest, France.

L Dahan (L)

Service d'Oncologie Digestive et d'Hépato-Gastroentrologie, La Timone University Hospital, Marseille, France.

T Conroy (T)

Département d'Oncologie Médicale, Institut de Cancérologie de Lorraine, Université de Lorraine, Vandœuvre-lès-Nancy, France.

F Ghiringhelli (F)

Département d'Oncologie Médicale, Centre Georges-Francois Leclerc, Dijon, France.

A Drouillard (A)

Service d'Hépato-Gastroenterologie, Francois Mitterrand University Hospital, Dijon.

F El Hajbi (F)

Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France.

E Samalin (E)

Département d'Oncologie Médicale, Institut Régional du Cancer de Montpellier, Montpellier, France.

S Hiret (S)

Département d'Oncologie Médicale, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.

S Delaine-Clisant (S)

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.

C Mariette (C)

FREnch EsoGastric Tumor (FREGAT) Working Group, Lille, France; Univ. Lille, Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France.

N Penel (N)

Département d'Oncologie Médicale, Centre Oscar Lambret, Lille, France; Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France.

G Piessen (G)

FREnch EsoGastric Tumor (FREGAT) Working Group, Lille, France; Univ. Lille, Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France.

M C Le Deley (MC)

Direction de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France; CESP, INSERM, Paris-Sud, Paris-Saclay University, 94805 Villejuif, France.

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