Sunitinib for the treatment of advanced pheochromocytomas/paragangliomas – A phase 2 clinical trial

#3869

Introduction: Malignant pheochromocytomas and paragangliomas (PPGLs) are rare neuroendocrine tumors with limited treatment options. Here, we report the preliminary results of SUTNET trial assessing safety and efficacy of sunitinib in advanced/unresectable PPGLs.

Aim(s): The primary endpoint was one-year progression-free survival (PFS) rate. Secondary endpoints included safety, overall response rate and overall survival.

Materials and methods: SUTNET is a single-arm, mono institutional, phase II study, in which patients (pts) with advanced/unresectable PPGLs diagnosis received sunitinib 50 mg/day (4-weeks-on/2-weeks-off) until progressive disease or unacceptable toxicity. To test a gain in PFS from 30% to 50%, the Simon's two stage design (alpha 10%, power 90%) required the assessment of 46 pts. The trial meets its primary endpoint if at least 18 pts will be alive without progression at 12 months.

Conference:

Presenting Author: Prinzi N

Authors: Prinzi N, Corti F, Capone I, Perrone F, Tamborini E,

Keywords: pheochromocytoma, paraganglioma, sunitinib, neuroendocrine,