Abstract
BackgroundNeuroendocrine tumors (NETs) are the second most common gastrointestinal malignancy after colon cancer. Up to 90% of patients with NETs develop liver metastases, which are a major determinant of symptoms and survival. Current guidelines recommend embolotherapy for progressive or symptomatic NET liver metastases, but the optimal technique among bland embolization, lipiodol chemoembolization, and drug-eluting bead chemoembolization remains unknown and controversial.Methods/designA prospective, open-label, multicenter randomized controlled trial will be conducted in patients with progressive or symptomatic unresectable NET liver metastases. Patients will be randomized to treatment with bland embolization, lipiodol chemoembolization, or drug-eluting microsphere chemoembolization, with 60 enrollees per arm. The primary endpoint will be hepatic progression-free survival (HPFS) following initial embolotherapy by RECIST criteria. The sample size is powered to detect an HR of 1.78 for HPFS following chemoembolization compared with bland embolization, which was estimated on the basis of existing retrospective studies. Secondary endpoints include overall progression-free survival, duration of symptom control, quality of life, rate of adverse events, and interval between embolotherapy cycles. Interim safety analyses will be performed at 10 and 30 patients per arm.DiscussionThe RETNET trial is a prospective, multicenter randomized controlled trial designed to determine the optimal embolotherapy technique for NET liver metastases.Trial registrationClinicalTrials.gov, NCT02724540. Registered on March 31, 2016.
Highlights
Neuroendocrine tumors (NETs) are the second most common gastrointestinal malignancy after colon cancer
Neuroendocrine tumors (NETs) are a heterogeneous family of neoplasms that arise from cells in the gastrointestinal (GI) tract, pancreas, and lung
Liver-directed embolotherapy encompasses distinct techniques, including “bland” embolization (BE) using embolic particles instilled via the hepatic artery to cut off tumor blood supply and transarterial chemoembolization (TACE) using either an ethiodized oil emulsion of chemotherapeutic drugs or drugs loaded onto embolic microspheres
Summary
Despite several decades of experience with embolotherapy for NET liver metastases, there remains uncertainty regarding the optimal treatment modality and a paucity of level I evidence. The Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET) will be the first multicenter prospective RCT aimed at elucidating these questions regarding optimal embolotherapy technique. The results of this study will help refine the role of embolotherapy for NET liver metastases by determining which, if any, embolotherapy technique confers superior HPFS and/or safety profile between BE, lipiodol TACE, and DEB-TACE. Author details 1Division of Interventional Radiology, University of Pennsylvania, Philadelphia, PA, USA. Author details 1Division of Interventional Radiology, University of Pennsylvania, Philadelphia, PA, USA. 2Department of Epidemiology & Biostatistics, University of Pennsylvania, Philadelphia, PA, USA. 3Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. 4Department of Radiology, Hospital of the University of Pennsylvania, 1 Silverstein, 3400 Spruce Street, Philadelphia, PA 19104, USA
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
