According to a new study published in the journal Annals of Oncology, researchers have found that vandetanib did not improve progression-free survival in patients with advanced biliary tract cancer.
For the phase 2 multi center study, researchers sought to investigate the safety and efficacy of vandetanib alone compared with vandetanib with gemcitabine or gemcitabine plus placebo in patients with advanced biliary tract cancer.
Researchers enrolled 173 patients and randomly assigned them 1:1:1 to receive either vandetanib 300mg orally daily alone, vandetanib 100mg orally daily plus gemcitabine 1,000mg/m2 IV on days 1 and 8 of each 21-day cycle, or gemcitabine 1,000mg/m2 IV on days 1 and 8 of each 21-day cycle plus placebo.
Results showed that the median progression-free survival was 105 days (95% CI: 72 - 155) for vandetanib monotherapy, 114 days (95% CI: 91 - 193) for vandetanib plus gemcitabine, and 148 days (95% CI: 71 - 225) for gemcitabine plus placebo (P = 0.18).
In addition, the vandetanib plus gemcitabine combination provided a slightly higher objective response rate over the other interventions. In regard to safety, the incidence of adverse effects was similar across all three treatment arms.
This phase II multicenter study evaluated the efficacy and tolerability of vandetanib monotherapy compared to vandetanib plus gemcitabine or gemcitabine plus placebo in patients with advanced biliary tract cancer (BTC). Vandetanib treatment did not improve progression-free survival (PFS) in patients with advanced BTC.