RT Journal Article
T1 Dovitinib in patients with gastrointestinal stromal tumour refractory and/or intolerant to imatinib.
A1 Joensuu, Heikki
A1 Blay, Jean-Yves
A1 Comandone, Alessandro
A1 Martin-Broto, Javier
A1 Fumagalli, Elena
A1 Grignani, Giovanni
A1 Del Muro, Xavier Garcia
A1 Adenis, Antoine
A1 Valverde, Claudia
A1 Pousa, Antonio Lopez
A1 Bouché, Olivier
A1 Italiano, Antoine
A1 Bauer, Sebastian
A1 Barone, Carlo
A1 Weiss, Claudia
A1 Crippa, Stefania
A1 Camozzi, Maura
A1 Castellana, Ramon
A1 Le Cesne, Axel
AB This multicentre phase II trial (DOVIGIST) evaluated the antitumour activity of dovitinib as second-line treatment of patients with gastrointestinal stromal tumour (GIST) refractory to imatinib or who do not tolerate imatinib. Patients received oral dovitinib 500 mg day-1, 5 days on/2 days off, until GIST progression or unacceptable toxicity, with an objective to evaluate efficacy, assessed as the disease control rate (DCR) at 12 weeks. Tumour assessment and response to dovitinib therapy were evaluated by Response Evaluation Criteria In Solid Tumours (RECIST v1.1) and the Choi criteria. Secondary objectives included assessment of progression-free survival (PFS), safety and tolerability, and DCR at the end of treatment. Thirty-eight of the 39 patients enrolled had histologically confirmed GIST. The DCR at 12 weeks was 52.6% (90% confidence interval (CI), 38.2-66.7%) meeting the preset efficacy criterion for the primary end point. The objective response rate (complete response+partial response) was 2.6% (1 of 38; 90% CI, 0.1-11.9%), and 5.3% (n=2; 90% CI, 0.9-15.7%) at the end of the study. The median PFS was 4.6 months (90% CI, 2.8-7.4 months). Dose interruption was required in 26 patients (66.7%), of which 18 (69.2%) were due to adverse events. The most frequently observed grade 3 adverse events included hypertension (n=7), fatigue (n=5), vomiting (n=4), hypertriglyceridaemia (n=4), and γ-glutamyltransferase increase (n=4). Dovitinib is an active treatment for patients with GIST who are intolerant to imatinib or whose GIST progresses on imatinib.
YR 2017
FD 2017-08-29
LK http://hdl.handle.net/10668/11536
UL http://hdl.handle.net/10668/11536
LA en
DS RISalud
RD Apr 10, 2025