177Lu-Dotatate therapy for patients with metastatic gastrointestinal neuroendocrine tumors: How to prepare your practice for optimal administration.

Objectives Successful treatment options for patients with metastatic gastrointestinal neuroendocrine tumors remain an unmet clinical need. This trend could change based on the results of the phase 3 NETTER-1 trial, which demonstrated improved progression-free survival in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors treated with peptide receptor radionuclide therapy 177Lu-Dotatate compared with high dose octreotide (Strosberg et al. Abstract 6LBA, European Cancer Congress 2015). Given that 177Lu-Dotatate has now received FDA fast-track designation, we propose to share the lessons we learned while participating in the phase 3 trial to help prepare other nuclear medicine departments for the optimal 177Lu-Dotatate administration in a clinical setting.

Methods 177Lu-Dotatate was administered in 4 cycles, every 8 weeks, with 30 mg of octreotide acetate LAR depot every 4 weeks. Each treatment visit required coordination of laboratory testing, pre-medication, EKGs, antiemetics, and patient monitoring. A point-of-contact person was designated in nuclear medicine to coordinate efforts between nuclear medicine, the study team, pharmacy, the radiation safety office, nursing and respiratory therapy staff. A research Quality Management Program form was utilized for dose preparation and administration documentation.

Results The lessons learned included the need for several preparation steps in advance of patient arrival, such as scheduling the dose delivery the day prior to treatment, proper medication ordering, confirmation of contact information on the treatment day for all teams involved, radiation safety training, dose preparation/administration planning, and specific patient care procedures, with coordination of proper timing for all procedures.

Conclusions While planning for the provision of 177Lu-Dotatate treatment may pose challenging coordination and implementation of new workflows, proper departmental and institutional preparation has enabled high quality patient care and safe delivery of a novel therapy using an unsealed source within a nuclear medicine department setting that is addressing an unmet clinical need for this patient population.