Dr Rocio Garcia-Carbonero (Hospital Universitario 12 de Octubre, Spain) presented the results of the randomised, double-blind phase 2 (n=106) and phase 3 (n=150) AXINET trial-GETNE-1107 (NCT01744249), which aimed to assess the efficacy of angiogenesis inhibitor axitinib in patients with advanced extra-pancreatic G1-G2 NETs.
Eligible patients (n=256; median age 61 years) were randomised to receive octreotide acetate long-acting release (30 mg every 4 weeks) with either axitinib (5 mg, twice daily; n=126) or placebo twice daily (n=130) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), time to progression, overall response rate (ORR), duration of response, biochemical response, and safety.
The primary endpoint was not met at this analysis; although median PFS favoured the axitinib arms, the difference did not reach statistical significance (17.2 vs 12.3 months; HR 0.816; P=0.169). However, ORR was significantly improved in axitinib- as opposed to placebo-treated patients (17.5% vs 3.8%; P=0.0004).
Adverse events occurred more frequently in the subjects receiving axitinib compared with placebo; grade 3-4 events occurred in 52% versus 13.8%, respectively. There were 3 treatment-related deaths, 1 in the axitinib arm (cardiac failure) and 2 in the placebo arm (myocardial infarction and hepatorenal syndrome).
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