Overall Survival (OS) Analysis of Sunitinib (SU) After Adjustment for Crossover (CO) in Patients With Pancreatic Neuroendocrine Tumors (NET)

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Introduction: A recent phase 3 trial of SU in pancreatic NET showed an improvement in progression-free survival (PFS) and OS. However, the OS benefit was confounded by early CO from placebo (PBO) to SU treatment.

Aim(s): To estimate the effect of SU on OS after adjusting for treatment CO using the Rank-Preserving Structural Failure Time (RPSFT) model.

Materials and methods: A trial of SU v. PBO was conducted and was halted early due to a PFS benefit for SU and more serious AEs/death with PBO. Patients on PBO could receive SU on disease progression or on trial termination. The Cox model used for intent-to-treat (ITT) analysis for OS was adjusted using an RPSFT model to estimate OS had treatment CO not been permitted.

Conference: 8th Annual ENETSConcerence (2011)

Presenting Author:

Authors: Ishak J, Valle J, Van Cutsem E, Lombard-Bohas C, Ruszniewski P,

Keywords: overall survival, crossover, sunitinib, NET, Rank-Preserving Structural Failure Time model,