A randomized study of 6 vs 3 years of adjuvant imatinib in patients with localized GIST at high risk of relapse.

Adjuvant therapy Imatinib mesylate gastrointestinal stromal tumors randomized clinical trial

Journal

Annals of oncology : official journal of the European Society for Medical Oncology
ISSN: 1569-8041
Titre abrégé: Ann Oncol
Pays: England
ID NLM: 9007735

Informations de publication

Date de publication:
04 Sep 2024
Historique:
received: 19 07 2024
revised: 22 08 2024
accepted: 27 08 2024
medline: 7 9 2024
pubmed: 7 9 2024
entrez: 6 9 2024
Statut: aheadofprint

Résumé

The administration of adjuvant imatinib during three years is indicated after resection of primary localized GIST at high risk of recurrence, but many patients relapse afterwards. IMADGIST (NCT02260505) was a multicenter open-label, randomized phase III study evaluating the maintenance of imatinib for 3 more years (6-years arm) compared to Interruption (3-years arm) from the day of randomization, conducted in the French Sarcoma Group. The primary endpoint was intent-to treat disease-free survival (DFS). Secondary endpoints include overall survival, time to imatinib resistance, response after imatinib reintroduction at relapse, safety. From December 24 Three additional years of adjuvant imatinib reduces the risk of relapse in patients who have received 3 years of adjuvant imatinib with an acceptable tolerance.

Sections du résumé

BACKGROUND BACKGROUND
The administration of adjuvant imatinib during three years is indicated after resection of primary localized GIST at high risk of recurrence, but many patients relapse afterwards.
METHODS METHODS
IMADGIST (NCT02260505) was a multicenter open-label, randomized phase III study evaluating the maintenance of imatinib for 3 more years (6-years arm) compared to Interruption (3-years arm) from the day of randomization, conducted in the French Sarcoma Group. The primary endpoint was intent-to treat disease-free survival (DFS). Secondary endpoints include overall survival, time to imatinib resistance, response after imatinib reintroduction at relapse, safety.
RESULTS RESULTS
From December 24
CONCLUSIONS CONCLUSIONS
Three additional years of adjuvant imatinib reduces the risk of relapse in patients who have received 3 years of adjuvant imatinib with an acceptable tolerance.

Identifiants

pubmed: 39241959
pii: S0923-7534(24)03924-3
doi: 10.1016/j.annonc.2024.08.2343
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024. Published by Elsevier Ltd.

Auteurs

J-Y Blay (JY)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon. Electronic address: jean-yves.blay@lyon.unicancer.fr.

C Schiffler (C)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon.

Olivier Bouché (O)

CHU & Université de Reims, Reims.

Mehdi Brahmi (M)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon.

F Duffaud (F)

Hôpital La Timone, & Université Aix-Marseille, Marseille.

M Toulmonde (M)

Institut Bergonié, Bordeaux.

B Landi (B)

Hôpital Européen George Pompidou, Paris.

W Lahlou (W)

Hôpital Européen George Pompidou, Paris.

D Pannier (D)

Centre Oscar Lambret, & Université Lille, Lille.

E Bompas (E)

Institut Cancérologie de l'Ouest, Nantes.

F Bertucci (F)

Institut Paoli-Calmette & Université Aix-Marseille, Marseille.

L Chaigneau (L)

CHU Besançon.

O Collard (O)

Hôpital Privé de la Loire, Saint-Etienne.

M Pracht (M)

Centre Eugene Marquis, Rennes.

C Henon (C)

Institut Gustave Roussy, Villejuif.

I Ray-Coquard (I)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon.

K Armoun (K)

CHU & Université de Reims, Reims.

S Salas (S)

Hôpital La Timone, & Université Aix-Marseille, Marseille.

M Spalato-Ceruso (M)

Institut Bergonié, Bordeaux.

A Adenis (A)

Centre Oscar Lambret, & Université Lille, Lille; Institut Gustave Roussy, Villejuif.

B Verret (B)

Institut de Cancerologie de Montpellier & CLCC Val d'Aurelle.

N Penel (N)

Centre Oscar Lambret, & Université Lille, Lille.

C Moreau-Bachelard (C)

Institut Cancérologie de l'Ouest, Nantes.

A Italiano (A)

Institut Bergonié, Bordeaux.

A Dufresne (A)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon.

S Metzger (S)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon.

S Chabaud (S)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon.

D Perol (D)

Centre Léon Bérard & Université Claude Bernard Lyon I, Lyon.

A Le Cesne (A)

Institut Gustave Roussy, Villejuif.

Classifications MeSH