| Added by | mollevi |
|---|---|
| Group name | EquipeMY |
| Item Type | Journal Article |
| Title | Dovitinib in patients with gastrointestinal stromal tumour refractory and/or intolerant to imatinib |
| Creator | Joensuu et al. |
| Author | Heikki Joensuu |
| Author | Jean-Yves Blay |
| Author | Alessandro Comandone |
| Author | Javier Martin-Broto |
| Author | Elena Fumagalli |
| Author | Giovanni Grignani |
| Author | Xavier Garcia Del Muro |
| Author | Antoine Adenis |
| Author | Claudia Valverde |
| Author | Antonio Lopez Pousa |
| Author | Olivier Bouché |
| Author | Antoine Italiano |
| Author | Sebastian Bauer |
| Author | Carlo Barone |
| Author | Claudia Weiss |
| Author | Stefania Crippa |
| Author | Maura Camozzi |
| Author | Ramon Castellana |
| Author | Axel Le Cesne |
| Abstract | BACKGROUND: 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. METHODS: 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. RESULTS: 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 ?-glutamyltransferase increase (n=4). CONCLUSIONS: Dovitinib is an active treatment for patients with GIST who are intolerant to imatinib or whose GIST progresses on imatinib. |
| Publication | British Journal of Cancer |
| Volume | 117 |
| Issue | 9 |
| Pages | 1278-1285 |
| Date | Oct 24, 2017 |
| Journal Abbr | Br. J. Cancer |
| Language | eng |
| DOI | 10.1038/bjc.2017.290 |
| ISSN | 1532-1827 |
| Library Catalog | PubMed |
| Extra | PMID: 28850565 PMCID: PMC5672922 |
| Tags | Adult, Aged, Benzimidazoles, Biomarkers, Tumor, clinic, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors, Humans, Imatinib Mesylate, Male, Middle Aged, Neoplasm Staging, Prognosis, Protein Kinase Inhibitors, Quinolones, Salvage Therapy |
| Date Added | 2018/11/13 - 17:30:20 |
| Date Modified | 2019/05/21 - 13:27:51 |
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