PMID- 31550719
OWN - NLM
STAT- MEDLINE
DCOM- 20200413
LR  - 20200413
IS  - 2296-5262 (Electronic)
IS  - 2296-5270 (Linking)
VI  - 42
IP  - 12
DP  - 2019
TI  - Safety of Imatinib Mesylate in a Multicenter Expanded Access Program in Adult 
      Patients with Gastrointestinal Stromal Tumors in the Adjuvant Setting.
PG  - 629-635
LID - 10.1159/000502749 [doi]
AB  - 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: In this 
      multicenter, open-label, single-arm trial, safety was assessed based on the 
      frequency of adverse events (AEs). 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: 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.
CI  - (c) 2019 S. Karger AG, Basel.
FAU - Reichardt, Peter
AU  - Reichardt P
AD  - Department of Oncology and Palliative Care, Sarcoma Center Berlin-Brandenburg, 
      Helios Klinikum Berlin-Buch, Berlin, Germany.
FAU - Schlemmer, Marcus
AU  - Schlemmer M
AD  - Department of Internal Medicine III, University Hospital Grosshadern, 
      Ludwig-Maximilians-Universitat Munchen, Munich, Germany, 
      Marcus.Schlemmer@barmherzige-muenchen.de.
FAU - Delgado Perez, Juan R
AU  - Delgado Perez JR
AD  - Department of Medical Oncology, University Hospital Virgen de las Nieves, 
      Granada, Spain.
FAU - Papai, Zsuzsanna
AU  - Papai Z
AD  - Department of Oncology, Medical Centre, Hungarian Defense Forces, Budapest, 
      Hungary.
FAU - Prausova, Jana
AU  - Prausova J
AD  - Department of Oncology, University Hospital Motol, 2nd Faculty of Medicine, 
      Charles University, Prague, Czechia.
FAU - Melichar, Bohuslav
AU  - Melichar B
AD  - Department of Oncology, Palacky University Medical School and Teaching Hospital 
      Olomouc, Olomouc, Czechia.
FAU - Fumagalli, Elena
AU  - Fumagalli E
AD  - Adult Mesenchymal Tumour and Rare Cancer Medical Oncology Unit, Cancer Medicine 
      Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
FAU - Barone, Carlo
AU  - Barone C
AD  - Division of Medical Oncology, University Hospital A. Gemelli, Rome, Italy.
FAU - Bauer, Sebastian
AU  - Bauer S
AD  - Department of Medical Oncology, Sarcoma Center, West German Cancer Center, 
      University Hospital, University of Duisburg-Essen, Essen, Germany.
FAU - Pustowka, Anette
AU  - Pustowka A
AD  - Novartis Pharma GmbH, Nuremberg, Germany.
FAU - Crippa, Stefania
AU  - Crippa S
AD  - Oncology Region Europe, Origgio, Italy.
FAU - Castellana, Ramon
AU  - Castellana R
AD  - Novartis Farmaceutica, Barcelona, Spain.
FAU - Quiering, Claudia
AU  - Quiering C
AD  - Novartis Pharma GmbH, Nuremberg, Germany.
FAU - Le Cesne, Axel
AU  - Le Cesne A
AD  - Department of Medical Oncology, Gustave Roussy Institute of Oncology, Villejuif, 
      France.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20190924
PL  - Switzerland
TA  - Oncol Res Treat
JT  - Oncology research and treatment
JID - 101627692
RN  - 0 (Protein Kinase Inhibitors)
RN  - 8A1O1M485B (Imatinib Mesylate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Chemotherapy, Adjuvant
MH  - Female
MH  - Gastrointestinal Neoplasms/*drug therapy/surgery
MH  - Gastrointestinal Stromal Tumors/*drug therapy/surgery
MH  - Humans
MH  - Imatinib Mesylate/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/*administration & dosage/adverse effects
MH  - Survival Analysis
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Adjuvant treatment
OT  - Gastrointestinal stromal tumor
OT  - Imatinib mesylate
OT  - Safety
OT  - Tolerability
OT  - Tyrosine kinase inhibitors
EDAT- 2019/09/25 06:00
MHDA- 2020/04/14 06:00
CRDT- 2019/09/25 06:00
PHST- 2018/12/19 00:00 [received]
PHST- 2019/08/14 00:00 [accepted]
PHST- 2019/09/25 06:00 [pubmed]
PHST- 2020/04/14 06:00 [medline]
PHST- 2019/09/25 06:00 [entrez]
AID - 000502749 [pii]
AID - 10.1159/000502749 [doi]
PST - ppublish
SO  - Oncol Res Treat. 2019;42(12):629-635. doi: 10.1159/000502749. Epub 2019 Sep 24.