No Overall Survival Benefit Observed with Second-Line Vandetanib in Advanced NSCLC
(ChemotherapyAdvisor) – In patients with advanced non–small-cell lung cancer (NSCLC) previously treated with an EGFR tyrosine kinase inhibitor and one or two chemotherapy regimens, vandetanib did not demonstrate an overall survival (OS) benefit vs. placebo, results of the multicenter, randomized, phase 3 ZEPHYR study reported in the Journal of Clinical Oncology online February 27.
The double-blind, placebo-controlled study randomly assigned patients 2:1 to receive vandetanib 300mg/day (n=617) or placebo (n=307); both groups also received best supportive care. Compared with placebo, no significant increase in OS, the primary end point, was detected in the vandetanib cohort (HR=0.95; P=0.527). Median OS was 8.5 months in the vandetanib group vs. 7.8 months for placebo.
For the secondary end points of progression-free survival and objective response rate, statistically significant advantages favored vandetanib, the investigators reported. Consistent with previous studies of the vandetanib 300mg dose in patients with NSCLC, some adverse events were higher with vandetanib than placebo; these included diarrhea (46% vs. 11%), rash (42% vs. 11%), and hypertension (26% vs. 3%).