A Randomized Controlled Study Comparing Treatment of Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEPNET) with 177Lu-DOTATATE Alone and in Combination with Capecitabine

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Introduction: PRRT with 177Lu-DOTATATE (LuTate) is an effective treatment option in patients with metastatic or inoperable GEP-NETs.

Aim(s): The effects of adding the radiosensitiser capecitabine were explored in patients with metastatic or otherwise inoperable GEPNETs receiving treatment with 177Lu-DOTATATE.

Materials and methods: The study was a two-arm randomized controlled, prospective, non-blinded study protocol opening in 2006. Subjects were assigned to treatment arms of LuTate alone (‘control’) or in combination with capecitabine (‘investigational’). LuTate in both arms was administered as four equal administrations with an intended cumulative dose of 800 mCi (29.6 GBq). Capecitabine treatment comprised 1650 mg/m2/day in two divided doses for first two weeks of each cycle starting on the morning of the day of administration of LuTate. OS, PFS and haematological toxicity were assessed. Wider availability of LuTate therapy on compassionate grounds lead to increasing patient request for LuTate therapy alone. Trial recruitment was terminated in 2013.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author: van der Zwan W

Authors: Van der Zwan W, Wyld D, Brabander T, Teunissen J, Kam B,

Keywords: PRRT, 177Lu-DOTATATE, Capecitabine, Xeloda, PFS, OS, Toxicity, GEP-NET, RCT, Randomized,