S-1/temozolomide versus S-1/temozolomide plus thalidomide in advanced pancreatic and non-pancreatic neuroendocrine tumors (STEM): A randomised, open-label, multicentre phase 2 trial

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Introduction: There are currently limited systemic treatment options for patients with advanced neuroendocrine tumors (NETS) and the efficacy of existing treatments is sub-optimal.

Aim(s): To evaluate the efficacy and safety of S-1/temozolomide with or without thalidomide for the treatment of NETS.

Materials and methods: A randomised, controlled, phase 2 trial conducted at eight hospitals in China. Adults (≥18 years) with unresectable/metastatic, pancreatic or non-pancreatic NETS, with an ECOG PS of 0−1, and progression on ≤2 previous therapies were randomised (1:1), stratified by pancreatic/non-pancreatic disease to receive S-1 40−60 mg orally twice daily on days 1−14 plus temozolomide 200 mg orally daily on days 10−14 in a 21-day cycle OR S-1 and temozolomide plus thalidomide orally nightly (100 mg on days 1−7,200 mg on days 8−14, and 300 mg from day 15). The primary endpoint was objective response rate (ORR). The study was registered at ClinicalTrials.gov: NCT03204019 (pancreatic group) and NCT03204032 (non-pancreatic group).

Conference:

Presenting Author:

Authors: Chi Y, Song L, Liu W, Zhou Y, Miao Y,

Keywords: S-1, temozolomide, thalidomide, neuroendocrine tumor,