177Lu-DOTATATE Plus 166Ho-Radioembolization in Patients with Neuroendocrine Tumours; A Single Center, Prospective, Interventional, Non-Comparative, Open Label, Phase II Study (HEPAR PLuS Study)

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Introduction: The liver is the most commonly affected organ in metastatic neuroendocrine disease and is the most incriminating factor for patient survival. Additional treatment of liver disease with radioembolization may improve outcome in NET patients with bulky residual liver disease after PRRT.

Aim(s): A phase 2 study (HEPAR PLuS) was initiated to assess effectiveness and toxicity of holmium-166 radioembolization (166Ho-RE) after PRRT with lutetium-177-DOTATATE.

Materials and methods: The HEPAR PLuS study included 30 patients with histologically confirmed grade 1 or 2 NET and >3 measurable residual liver metastases according to RECIST 1.1 received 166Ho-RE within 20 weeks after the 4th and last cycle of PRRT. Primary objectives: objective response rate (ORR = complete plus partial response) after 3 and 6 months according to RECIST 1.1 in the liver. Secondary endpoints included patient-based ORR, toxicity profile according to CTCAE v4.03 and quality of life assessments according to EORTC QLQ-C30 and GI.NET21 questionnaires.

Conference: 17th Annual ENETSConcerence (2020)

Presenting Author: Braat A

Authors: Braat A, Rutger B, Van Rooij R, Braat M, Wessels F,

Keywords: NET, PRRT, SIRT, Radioembolization, Ho-166, Neuroendocrine tumor,