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- Title
Vandetanib (100 mg) in patients with locally advanced or metastatic hereditary medullary thyroid cancer.
- Authors
Robinson, Bruce G; Paz-Ares, Luis; Krebs, Annetta; Vasselli, James; Haddad, Robert
- Abstract
<bold>Purpose: </bold>Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor-2 and epidermal growth factor receptor tyrosine kinases that also inhibits rearranged during transfection kinase activity. Vandetanib (300 mg/d) has previously demonstrated antitumor activity in patients with advanced hereditary medullary thyroid cancer (MTC). This study investigated the efficacy and safety of 100 mg/d vandetanib in patients with advanced hereditary MTC.<bold>Patients and Methods: </bold>Eligible patients with unresectable, measurable, locally advanced, or metastatic hereditary MTC received 100 mg/d vandetanib. Upon disease progression, eligible patients could enter postprogression treatment with 300 mg/d vandetanib until a withdrawal criterion was met. The primary objective was to assess the objective response rate by response evaluation criteria in solid tumors.<bold>Results: </bold>The study comprised 19 patients (13 males, six females; mean age 45 yr). Confirmed objective partial responses were observed in three patients, yielding an objective response rate of 16% (95% confidence interval 3.4-39.6). Stable disease lasting 24 wk or longer was reported in a further 10 patients (53%); the disease control rate was therefore 68% (95% confidence interval 43.4-87.4). Serum levels of calcitonin and carcinoembryonic antigen showed a sustained 50% or greater decrease from baseline in 16% (three of 19) and 5% (one of 19) of patients, respectively. Adverse events were predominantly grade 1 or 2 and consistent with previous vandetanib monotherapy studies.<bold>Conclusions: </bold>Vandetanib at a once-daily dose of 100 mg has clinically relevant antitumor activity in patients with locally advanced or metastatic hereditary MTC and an overall acceptable safety profile.
- Subjects
ANTINEOPLASTIC agents; CALCITONIN; CANCER cells; CLINICAL trials; COMPARATIVE studies; COMPUTED tomography; GENES; HETEROCYCLIC compounds; MAGNETIC resonance imaging; RESEARCH methodology; MEDICAL cooperation; METASTASIS; PIPERIDINE; RESEARCH; THYROID gland tumors; TUMOR antigens; EVALUATION research; BLIND experiment; PROTEIN kinase inhibitors; THERAPEUTICS
- Publication
Journal of Clinical Endocrinology & Metabolism, 2010, Vol 95, Issue 6, p2664
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/jc.2009-2461