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

The 2018 Food and Drug Administration approval of( 177)Lu-DOTA-TATE for the treatment of somatostatin receptor-positive neuroen-docrine 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,Lu- 177-DOTATATE, has dra-matically impacted NET patient management. The focus of this paper is to review clinical considerations associated with imple-menting a Lu-177-DOTATATE program. We review receptor-based NET radiopharmaceuticals;Lu- 177-DOTATATE patient selection cri-teria; administration methods; clinical, regulatory, and radiation safety considerations; technical factors; tissue dosimetry; and reimbursement guidelines.