Titre :

Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib.

Auteur(s) :

Gronchi, Alessandro [Auteur]
Fondazione IRCCS Istituto Nazionale Tumori - National Cancer Institute [Milan]
Bonvalot, Sylvie [Auteur]
Institut Curie [Paris]
Poveda Velasco, Andres [Auteur]
Kotasek, Dusan [Auteur]
University of Adelaide
Rutkowski, Piotr [Auteur]
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology [MCMCC]
Hohenberger, Peter [Auteur]
University Hospital Mannheim | Universitätsmedizin Mannheim
Fumagalli, Elena [Auteur]
IRCCS Istituto Nazionale dei Tumori [Milano]
Judson, Ian R. [Auteur]
Italiano, Antoine [Auteur]
Institut Bergonié [Bordeaux]
Gelderblom, Hans J. [Auteur]
Leiden University Medical Center [LUMC]
Van Coevorden, Frits [Auteur]
Netherlands Cancer Institute [NKI]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Kopp, Hans-Georg [Auteur]

Duffaud, Florence [Auteur]
Hôpital de la Timone [CHU - APHM] [TIMONE]
Goldstein, David [Auteur]
Prince of Wales Hospital
Broto, Javier Martin [Auteur]
Hospital Universitario Virgen del Rocío [Sevilla]
Wardelmann, Eva [Auteur]
University Hospital Münster - Universitaetsklinikum Muenster [Germany] [UKM]
Marréaud, Sandrine [Auteur]
European Organisation for Research and Treatment of Cancer [Bruxelles] [EORTC]
Smithers, Mark [Auteur]
The University of Queensland [UQ [All campuses : Brisbane, Dutton Park Gatton, Herston, St Lucia and other locations]]
Le Cesne, Axel [Auteur]
Institut Gustave Roussy [IGR]
Zaffaroni, Facundo [Auteur]
European Organisation for Research and Treatment of Cancer [Bruxelles] [EORTC]
Litière, Saskia [Auteur]
European Organisation for Research and Treatment of Cancer [Bruxelles] [EORTC]
Blay, Jean-Yves [Auteur]
Centre Léon Bérard [Lyon]
Casali, Paolo G. [Auteur]
Università degli Studi di Milano = University of Milan [UNIMI]

Titre de la revue :

JAMA SURGERY

Nom court de la revue :

JAMA Surg

Pagination :

e200397

Date de publication :

2020-04-04

ISSN :

2168-6262

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Importance The association between quality of surgery and overall survival in patients affected by localized gastrointestinal stromal tumors (GIST) is not completely understood. Objective To assess the risk of death ...
Lire la suite >Importance The association between quality of surgery and overall survival in patients affected by localized gastrointestinal stromal tumors (GIST) is not completely understood. Objective To assess the risk of death with and without imatinib according to microscopic margins status (R0/R1) using data from a randomized study on adjuvant imatinib. Design, Setting, and Participants This is a post hoc observational study on patients included in the randomized, open-label, phase III trial, performed between December 2004 and October 2008. Median follow-up was 9.1 years (IQR, 8-10 years). The study was performed at 112 hospitals in 12 countries. Inclusion criteria were diagnosis of primary GIST, with intermediate or high risk of relapse; no evidence of residual disease after surgery; older than 18 years; and no prior malignancies or concurrent severe/uncontrolled medical conditions. Data were analyzed between July 17, 2017, and March 1, 2020. Interventions Patients were randomized after surgery to either receive imatinib (400 mg/d) for 2 years or no adjuvant treatment. Randomization was stratified by center, risk category (high vs intermediate), tumor site (gastric vs other), and quality of surgery (R0 vs R1). Tumor rupture was included in the R1 category but also analyzed separately. Main Outcomes and Measures Primary end point of this substudy was overall survival (OS), estimated using Kaplan-Meier method and compared between R0/R1 using Cox models adjusted for treatment and stratification factors. Results A total of 908 patients were included; 51.4% were men (465) and 48.6% were women (440), and the median age was 59 years (range, 18-89 years). One hundred sixty-two (17.8%) had an R1 resection, and 97 of 162 (59.9%) had tumor rupture. There was a significant difference in OS for patients undergoing an R1 vs R0 resection, overall (hazard ratio [HR], 2.05; 95% CI, 1.45-2.89) and by treatment arm (HR, 2.65; 95% CI, 1.37-3.75 with adjuvant imatinib and HR, 1.86; 95% CI, 1.16-2.99 without adjuvant imatinib). When tumor rupture was excluded, this difference in OS between R1 and R0 resections disappeared (HR, 1.05; 95% CI, 0.54-2.01). Conclusions and Relevance The difference in OS by quality of surgery with or without imatinib was associated with the presence of tumor rupture. When the latter was excluded, the presence of R1 margins was not associated with worse OS. Trial Registration ClinicalTrials.gov Identifier: NCT00103168Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Date de dépôt :

2023-11-15T09:05:08Z
2023-12-06T09:17:04Z