作者
Sophie Leboulleux, Lars Bastholt, Thomas Krause, Christelle de la Fouchardiere, Jan Tennvall, Ahmad Awada, José Manuel Gómez, Françoise Bonichon, Laurence Leenhardt, Christine Soufflet, Muriel Licour, Martin J Schlumberger
发表日期
2012/9/1
期刊
The lancet oncology
卷号
13
期号
9
页码范围
897-905
出版商
Elsevier
简介
Background
No effective standard treatment exists for patients with radioiodine-refractory, advanced differentiated thyroid carcinoma. We aimed to assess efficacy and safety of vandetanib, a tyrosine kinase inhibitor of RET, VEGFR and EGFR signalling, in this setting.
Methods
In this randomised, double-blind, phase 2 trial, we enrolled adults (aged ≥18 years) with locally advanced or metastatic differentiated thyroid carcinoma (papillary, follicular, or poorly differentiated) at 16 European medical centres. Eligible patients were sequentially randomised in a 1:1 ratio with a standard computerised scheme to receive either vandetanib 300 mg per day (vandetanib group) or matched placebo (placebo group), balanced by centre. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population based on investigator assessment. This study is registered with ClinicalTrials.gov, number …
引用总数
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