CHICAGO, IL— Apatinib, an investigational oral, small-molecule selective tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2 (VEGFR2), was associated with prolonged survival among patients with advanced gastric cancer, according to findings from a multicenter randomized, double-blind, placebo-controlled phase 3 study presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.
The study offers “new hope” for development of additional treatment options for this frequently aggressive malignancy, according to the study’s authors.
“This study further confirmed the efficacy and safety of apatinib in patients with advanced gastric cancer,” said Jin Li, MD, of the Fudan University Cancer Hospital in Shanghai, China.
A total of 273 patients with advanced gastric cancer for whom second-line chemotherapy had failed were randomly assigned 2:1 to receive placebo (n=92) or oral 850 mg apatinib daily, for 28-day cycles (n=181). Patients who had prior VEGFR inhibitor treatment were not eligible to participate in the study.
Fourteen patients in the placebo group crossed over to the apatinib group after disease progression.
Median overall survival (OS) was significantly prolonged among patients in the apatinib group, compared to those in the placebo group (6.5 months vs. 4.7 months; hazard ratio [HR], 0.709; 95% CI: 0.537-0.937); P < 0.0149), Dr. Li reported.
Apatinib was also associated with longer progression-free survival (PFS; median PFS, 2.6 months vs. 1.8 months; P < 0.0001).
Objective response rates for apatinib and placebo were 2.84% and 0%. Disease control rate was 42.05%, compared to 8.79% in the control group.
Apatinib was “generally well tolerated,” Dr. Li reported.
AEs included hypertension, proteinuria, hand-foot syndrome, bleeding, cardiac and liver toxicities, but in most cases, these were “manageable and reversible,” he said. Grade 3/4 adverse events reported in 5% or more of patients taking apatinib included hand-foot syndrome (8.5%), transaminase elevations (7.95%), hyperbilirubinemia (7.39%), and hypophosphatemia (5.1%).
- Qin S. Abstract 4003. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.