Practical Considerations for Implementation of 177Lu-DOTATATE Neuroendocrine Tumor Treatment Programs

Abstract

The 2018 Food and Drug Administration approval of 177Lu-DOTA-TATE for the treatment of somatostatin receptor–positive neuroendocrine tumors (NETs) represents a paradigm-shifting approach to cancer treatments around the globe. Gastroenteropancreatic NETs overexpress the somatostatin subtype receptor 2, which is now exploited for receptor-based imaging and therapy, thus generating significant progress in the diagnosis and treatment of this orphan disease. The recent Food and Drug Administration approval of receptor-based PET radiopharmaceuticals and a new peptide receptor radiopharmaceutical therapy, 177Lu-DOTATATE, has dramatically impacted NET patient management. The focus of this paper is to review clinical considerations associated with implementing a 177Lu-DOTATATE program. We review receptor-based NET radiopharmaceuticals; 177Lu-DOTATATE patient selection criteria; administration methods; clinical, regulatory, and radiation safety considerations; technical factors; tissue dosimetry; and reimbursement guidelines.