Safety of Imatinib Mesylate in a Multicenter Expanded Access Program in Adult Patients with Gastrointestinal Stromal Tumors in the Adjuvant Setting.
Adult
Aged
Aged, 80 and over
Chemotherapy, Adjuvant
Female
Gastrointestinal Neoplasms
/ drug therapy
Gastrointestinal Stromal Tumors
/ drug therapy
Humans
Imatinib Mesylate
/ administration & dosage
Male
Middle Aged
Protein Kinase Inhibitors
/ administration & dosage
Survival Analysis
Treatment Outcome
Young Adult
Adjuvant treatment
Gastrointestinal stromal tumor
Imatinib mesylate
Safety
Tolerability
Tyrosine kinase inhibitors
Journal
Oncology research and treatment
ISSN: 2296-5262
Titre abrégé: Oncol Res Treat
Pays: Switzerland
ID NLM: 101627692
Informations de publication
Date de publication:
2019
2019
Historique:
received:
19
12
2018
accepted:
14
08
2019
pubmed:
25
9
2019
medline:
14
4
2020
entrez:
25
9
2019
Statut:
ppublish
Résumé
Gastrointestinal stromal tumors (GISTs) are mesenchymal tumors most often caused by activating mutations of the KIT gene. KIT tyrosine kinase inhibitors provide targeted therapy for the underlying genetic mutation, and adjuvant therapy is indicated for patients who are at significant risk of relapse following GIST resection. This is a report of the safety of imatinib in patients with GIST in the adjuvant setting in an expanded access program. In this multicenter, open-label, single-arm trial, safety was assessed based on the frequency of adverse events (AEs). Three hundred patients were treated and analyzed; 40 patients discontinued treatment. Median overall exposure during the program was 181 days (range 9-420); most patients (260/300 treated) completed the study. Six patients had disease recurrence, 4 of whom discontinued. In line with previously published reports, the most frequent AEs were nausea, diarrhea, and periorbital edema. The AEs were mild to moderate in most cases (76%). These findings are in agreement with the known safety profile of imatinib and confirm the safety of imatinib at 400 mg/day in the adjuvant setting. The incidence of severe AEs was low.
Sections du résumé
BACKGROUND
BACKGROUND
Gastrointestinal stromal tumors (GISTs) are mesenchymal tumors most often caused by activating mutations of the KIT gene. KIT tyrosine kinase inhibitors provide targeted therapy for the underlying genetic mutation, and adjuvant therapy is indicated for patients who are at significant risk of relapse following GIST resection. This is a report of the safety of imatinib in patients with GIST in the adjuvant setting in an expanded access program.
METHODS
METHODS
In this multicenter, open-label, single-arm trial, safety was assessed based on the frequency of adverse events (AEs).
RESULTS
RESULTS
Three hundred patients were treated and analyzed; 40 patients discontinued treatment. Median overall exposure during the program was 181 days (range 9-420); most patients (260/300 treated) completed the study. Six patients had disease recurrence, 4 of whom discontinued. In line with previously published reports, the most frequent AEs were nausea, diarrhea, and periorbital edema. The AEs were mild to moderate in most cases (76%).
CONCLUSIONS
CONCLUSIONS
These findings are in agreement with the known safety profile of imatinib and confirm the safety of imatinib at 400 mg/day in the adjuvant setting. The incidence of severe AEs was low.
Identifiants
pubmed: 31550719
pii: 000502749
doi: 10.1159/000502749
doi:
Substances chimiques
Protein Kinase Inhibitors
0
Imatinib Mesylate
8A1O1M485B
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
629-635Informations de copyright
© 2019 S. Karger AG, Basel.