Improved progression-free survival, disease control rate, objective and biochemical response
TUESDAY, Oct. 25 (HealthDay News) -- Administration of vandetanib to patients with advanced medullary thyroid carcinoma (MTC) improves progression-free survival (PFS) compared to placebo, according to a study published online Oct. 24 in the Journal of Clinical Oncology.
Samuel A. Wells Jr., M.D., from the National Institutes of Health in Bethesda, Md., and colleagues evaluated the use of vandetanib in patients with MTC. A total of 331 patients with advanced MTC were selected between December 2006 and November 2007 and assigned to receive either vandetanib 300 mg/day or placebo. The patients were able to choose to receive open-label vandetanib on objective disease progression. PFS, determined using independent central Response Evaluation Criteria in Solid Tumor assessments was the primary end point.
The investigators found that, at the data cut-off point, 15 percent of patients had died and 37 percent had progressed. PFS was significantly improved for vandetanib versus placebo (hazard ratio, 0.46). There was also a statistically significant improvement in objective response rate, disease control rate, and biochemical response. At data cut-off, the overall survival data were immature and will be analyzed when 50 percent of the patients have died. Compared to placebo, common adverse events, including diarrhea, rash, nausea, hypertension, and headache occurred more frequently with vandetanib.
"Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC," the authors write.
Several authors disclosed financial relationships with pharmaceutical companies, including AstraZeneca, which funded the study and manufactures vandetanib. The study was also partially funded by Mudskipper Bioscience.
Full Text (subscription or payment may be required)