Adding vandetanib to gemcitabine failed to significantly prolong overall survival among patients with advanced pancreatic cancer, according to a study published in The Lancet Oncology.1
The novel tyrosine kinase inhibitor (TKI), vandetanib, inhibits VEGFR2, RET, and EGFR, all of which are in involved in the pathogenesis of pancreatic cancer. Investigators evaluated the efficacy and safety of vandetanib in combination with gemcitabine in patients with advanced pancreatic cancer.
For the multicenter, double-blind, phase 2 ViP trial (ClinicalTrials.gov Identifier: NCT01601808), investigators enrolled 142 previously untreated adult patients diagnosed with locally advanced or metastatic pancreatic cancer. Participants were randomly assigned 1:1 to receive vandetanib plus gemcitabine or placebo plus gemcitabine until disease progression or unacceptable toxicity.
Results showed no statistically significant difference in overall survival between the 2 treatment groups (hazard ratio, 1.21; 80.8% CI, 0.95-1.53; P = .303). Median overall survival was 8.83 months (95% CI, 7.11-11.58) with vandetanib vs 8.95 months (95% CI, 6.55-11.74) with placebo.
The most frequently reported grade 3 to 4 adverse events in the vandetanib arm were neutropenia in 49% of the 72 patients, thrombocytopenia in 28%, fatigue in 24%, leukopenia in 17%, and hypertension in 13%. There were no treatment-related deaths in either arm.
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Although the findings demonstrated no survival benefit with vandetanib in this population, further research is needed to determine whether certain subgroups or patients with specific pancreatic cancer subtypes may benefit from TKI therapy.
- Middleton G, Palmer DH, Greenhalf W, et al. Vandetanib plus gemcitabine versus placebo plus gemcitabine in locally advanced or metastatic pancreatic carcinoma (ViP): a prospective, randomised, double-blind, multicentre phase 2 trial. Lancet Oncol. 2017 March 1. doi: 10.1016/S1470-2045(17)30084-0 [Epub ahead of print]