Combination of Lanreotide Autogel and Temozolomide in Patients with Progressive Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET) - A Pilot-Study

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Introduction: Therapeutic options for patients with advanced progressive GEP-NET are still limited.

Aim(s): To evaluate the combination of Lanreotide and Temozolomide in progressive G1 or G2 GEP-NET.

Materials and methods: A total of 40 patients with advanced progressive G1 or G2 GEP-NET are to be treated with Lanreotide Autogel 120mg + Temozolomide for 6 months (combination phase). In case of clinical benefit defined as complete or partial response (CR, PR) or stable disease (SD) after combination phase patients are randomized to either Lanreotide alone (maintenance phase) or observation without specific intervention. Disease control rate (CR, PR, SD) after 6 months of combination treatment is the primary endpoint. After 15 patients have been treated for at least 4 months safety assessment is prespecified and provided to Data Safety Monitoring Committee.

Conference: 13th Annual ENETSConcerence (2016)

Presenting Author: Raderer M

Authors: Raderer M, Hörsch D, Lahner H, Rinke A, Denecke T,

Keywords: GEP-NET, Lanreotide, Temozolomide,