Sunitinib (SU) in Patients with Advanced, Progressive Pancreatic Neuroendocrine Tumors (pNET): Final Overall Survival (OS) Results from a Phase III Randomized Study Including Adjustment for Crossover

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Introduction: This pivotal, Phase 3, double-blind study of SU in patients (pts) with advanced, progressive pNETs met its primary endpoint with median progression-free survival of 11.4 months (mo) for SU vs 5.5 mo for placebo (PBO; HR=0.42; 95% CI 0.26–0.66; p<0.001). OS difference favored SU (HR=0.41; 95% CI 0.19–0.89; p=0.02). At 2 years after study closure, median OS was 33.0 mo for SU vs 26.7 mo for PBO (HR=0.71; 95% CI 0.47–1.09; p=0.115).

Aim(s): To report final OS at 5 years follow-up since study closure.

Materials and methods: Pts were randomly assigned (1:1) to SU 37.5 mg/d (n=86) or PBO (n=85). Pts receiving PBO could crossover to SU at disease progression or study closure. OS was analyzed using the Kaplan-Meier method and Cox proportional hazards model in the intent-to-treat population. Also, OS data were analyzed using 3 different methods to adjust for the crossover effect.

Conference: 13th Annual ENETSConcerence (2016)

Presenting Author: Raymond E

Authors: Raymond E, Niccoli P, Castellano D, Valle J, Hammel P,

Keywords: sutent, OS,