Initial experience and lessons learned with implementing Lutetium-177-dotatate radiopharmaceutical therapy in a radiation oncology–based program

Abstract

PURPOSE: To assist radiation oncology centers in implementing Lutetium-177-dotatate ( 177 Lu) radiopharmaceutical therapy for midgut neuroendocrine tumors. Here we describe our workflow and how it was revised based on our initial experience on an expanded access protocol (EAP). METHODS: A treatment team/area was identified. An IV-pump-based infusion technique was implemented. Exposure-based techniques were implemented to determine completion of administration, administered activity, and patient releasability. Acute toxicities were assessed at each fraction. A workflow failure modes and effects analysis (FMEA) was performed. RESULTS: A total of 22 patients were treated: 11 patients during EAP (36 administrations) and 11 patients after EAP (44 administrations). Mean 177 Lu infusion time was 37 min (range 26e65 min). Mean administered activity was 97% (range 90e99%). Mean patient exposures at 1 m were 1.9 mR/h (range 1.0e4.1 mR/h) post-177 Lu and 0.9 mR/h (range 0.4e1.8 mR/h) at discharge, rendering patients releasable with instructions. Treatment area was decontaminated and released same day. All patients in the EAP experienced nausea, and nearly half experienced emesis despite premedication with antiemetics. Peripheral IV-line complications occurred in six treatments (16.7%), halting administration in 2 cases (5.6%). We transitioned to peripherally inserted central catheter (PICC)-lines and revised amino acid formulary after the EAP. The second cohort of 11 patients after EAP were analyzed for PICC-line complications and acute toxicity. Nausea and emesis rates decreased (nausea G1þ 61%e27%; emesis G1þ 23%e7%), and no PICC complications were observed. FMEA revealed that a failure in amino acid preparation was the highest risk. CONCLUSION: 177 Lu-dotatate can be administered safely in an outpatient radiation oncology department.

177Lu-Dotatate administration using an infusion pump or a peristaltic pump: comparison of two methods

“…The injection protocol used must therefore be as safe as possible. In this regard, Maughan et al 21 developed a failure modes and effects analysis (FMEA) workflow of the entire PRRT patient management process, which identifies the critical points of vigilance during administration, independently of the method. Regardless of the infusion method, appropriate radiation protection precautions and aseptic technique must also be used during the preparation and administration of the TRT.…”

A Primer on Radiopharmaceutical Therapy

“…However, as the radiopharmaceutical space is rapidly expanding with likely increased reimbursement as well as dosimetry and treatment planning, more radiation oncology departments may choose to make capital investments to build their own RPT programs. Several radiation oncology departments have been early leaders in this area, including the group at Washington University in St. Louis who have described their experience implementing a [ 177 Lu]Lu-DOTATATE program within their existing outpatient radiation oncology clinic (61). For additional information, a comprehensive guide on how to initiate and operate a Theranostics program was recently published (62).…”

Clinical Best Practices for Radiation Safety During Lutetium-177 Therapy

“…Panelists noted that only the surfaces most likely to become contaminated need to be covered. This includes areas such as the floor and wall immediately surrounding the toilet, the toilet seat, and the sink handles ( Nelson and Sheetz 2019 ; Berry et al 2020 ; Maughan et al 2021 ). Paper or an absorbent pad should also be placed on the patient chair or bed in case of incontinence.…”

“…Many of the sites used an infusion pump for administration, placing the dose vial inline between a saline bag and the pump. This setup is described in further detail by Maughan et al (2021) . This infusion pump setup is advantageous from a radiation safety perspective because the vial containing the activity can sit in the base of a shielded pig, effectively limiting radiation fields to a small cone above the vial.…”