Ten-Year Progression-Free and Overall Survival in Patients With Unresectable or Metastatic GI Stromal Tumors: Long-Term Analysis of the European Organisation for Research and Treatment of Cancer, Italian Sarcoma Group, and Australasian Gastrointestinal Trials Group Intergroup Phase III Randomized Trial on Imatinib at Two Dose Levels.

Détails

ID Serval
serval:BIB_7389B430762C
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Ten-Year Progression-Free and Overall Survival in Patients With Unresectable or Metastatic GI Stromal Tumors: Long-Term Analysis of the European Organisation for Research and Treatment of Cancer, Italian Sarcoma Group, and Australasian Gastrointestinal Trials Group Intergroup Phase III Randomized Trial on Imatinib at Two Dose Levels.
Périodique
Journal of clinical oncology
Auteur(s)
Casali P.G., Zalcberg J., Le Cesne A., Reichardt P., Blay J.Y., Lindner L.H., Judson I.R., Schöffski P., Leyvraz S., Italiano A., Grünwald V., Pousa A.L., Kotasek D., Sleijfer S., Kerst J.M., Rutkowski P., Fumagalli E., Hogendoorn P., Litière S., Marreaud S., van der Graaf W., Gronchi A., Verweij J.
Collaborateur(s)
European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group, Italian Sarcoma Group, and Australasian Gastrointestinal Trials Group
ISSN
1527-7755 (Electronic)
ISSN-L
0732-183X
Statut éditorial
Publié
Date de publication
20/05/2017
Peer-reviewed
Oui
Volume
35
Numéro
15
Pages
1713-1720
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Résumé
Purpose To report on the long-term results of a randomized trial comparing a standard dose (400 mg/d) versus a higher dose (800 mg/d) of imatinib in patients with metastatic or locally advanced GI stromal tumors (GISTs). Patients and Methods Eligible patients with advanced CD117-positive GIST from 56 institutions in 13 countries were randomly assigned to receive either imatinib 400 mg or 800 mg daily. Patients on the 400-mg arm were allowed to cross over to 800 mg upon progression. Results Between February 2001 and February 2002, 946 patients were accrued. Median age was 60 years (range, 18 to 91 years). Median follow-up time was 10.9 years. Median progression-free survival times were 1.7 and 2.0 years in the 400- and 800-mg arms, respectively (hazard ratio, 0.91; P = .18), and median overall survival time was 3.9 years in both treatment arms. The estimated 10-year progression-free survival rates were 9.5% and 9.2% for the 400- and 800-mg arms, respectively, and the estimated 10-year overall survival rates were 19.4% and 21.5%, respectively. At multivariable analysis, age (< 60 years), performance status (0 v ≥ 1), size of the largest lesion (smaller), and KIT mutation (exon 11) were significant prognostic factors for the probability of surviving beyond 10 years. Conclusion This trial was carried out on a worldwide intergroup basis, at the beginning of the learning curve of the use of imatinib, in a large population of patients with advanced GIST. With a long follow-up, 6% of patients are long-term progression free and 13% are survivors. Among clinical prognostic factors, only performance status, KIT mutation, and size of largest lesion predicted long-term outcome, likely pointing to a lower burden of disease. Genomic and/or immune profiling could help understand long-term survivorship. Addressing secondary resistance remains a therapeutic challenge.

Mots-clé
Adult, Aged, Antineoplastic Agents/administration & dosage, Cross-Over Studies, Disease-Free Survival, Dose-Response Relationship, Drug, Female, Gastrointestinal Neoplasms/drug therapy, Gastrointestinal Neoplasms/pathology, Gastrointestinal Stromal Tumors/drug therapy, Gastrointestinal Stromal Tumors/pathology, Humans, Imatinib Mesylate/administration & dosage, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Metastasis, Prognosis
Pubmed
Web of science
Création de la notice
26/06/2017 16:59
Dernière modification de la notice
20/08/2019 14:31
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