Abstract
Background177Lu-DOTATATE peptide receptor radionuclide therapy is administered to patients on an inpatient and outpatient basis for the treatment of well-differentiated, metastatic neuroendocrine tumours. Following administration, these patients present an external radiation hazard due to the gamma emissions of lutetium-177. The purpose of this study was to determine precautions to be observed by 177Lu-DOTATATE patients to restrict the dose received by patients’ family members to less than 5 mSv in 5 years and members of the public to less than 1 mSv per year in line with the current UK legislation. Retrospective data from therapeutic administrations of 177Lu-DOTATATE (Mallinckrodt Pharmaceuticals) and Lutathera® (Advanced Accelerator Applications) were analysed to measure activity retention at discharge. Patient dose rate measurements were assumed to follow the same activity decay curve as that derived from a least squares fit of geometric mean counts in planar whole-body scans performed at four time points post-administration. Combining this with social contact times, the cumulative dose received through contact with the patient was estimated and an iterative process used to determine the length of contact restrictions to ensure the relevant dose constraints are not exceeded.ResultsOn average, 36% of the administered activity was retained at the time of discharge for inpatients receiving 177Lu-DOTATATE (Mallinckrodt). Retentions of 24% and 38% were measured for Lutathera® inpatients and outpatients respectively. Inpatients should restrict day contact and sleep separately from their partner for 15 days and remain off work for 5 days post-therapy. Contact with children for whom the patient is the main carer should be restricted for 16, 13 and 9 days for children below 2, 2–5 and 5–11 years respectively. One additional day is added to outpatient restriction periods, except for children aged 2–5 years which remains 13 days. No private transport restrictions are required. Patients should limit travel by public transport to 1 h on the day of discharge.ConclusionRestrictions are necessary to limit radiation dose to members of patients’ household and the public. Proposed precautions for inpatient and outpatient 177Lu-DOTATATE therapy protocols restrict the dose received to less than the limit imposed by the UK legislation.
Highlights
IntroductionFollowing administration, these patients present an external radiation hazard due to the gamma emissions of lutetium-177
177Lu-DOTATATE peptide receptor radionuclide therapy is administered to patients on an inpatient and outpatient basis for the treatment of welldifferentiated, metastatic neuroendocrine tumours
The 177Lu-DOTATATE binds to somatostatin receptors that are overexpressed on the surface of Neuroendocrine tumour (NET) cells, thereby providing a means of delivering targeted radiation directly to the tumour. 177Lu-DOTATATE has been shown to improve tumour response rates and progression-free survival compared with alternative treatments whilst resulting in few serious adverse effects [1, 2], which is consistent with the outcomes of Lutathera® treatment in the randomised phase 3 Neuroendocrine Tumours Therapy (NETTER-1) trial [3]
Summary
Following administration, these patients present an external radiation hazard due to the gamma emissions of lutetium-177. Whilst proving advantageous as a means of post-therapy imaging and dosimetry measurements, these γ emissions present an external radiation hazard to those who come into contact with the patient, hospital staff, family and members of the public Another source of risk arises from the biological excretion of the radiopharmaceutical that occurs primarily through the urine and the majority of which takes place in the first 2 days following treatment [4, 6]. Work by Calais and Turner [7] has shown that outpatient therapy is acceptable within Australia’s regulatory framework where this is routinely carried out, and Olmstead et al have demonstrated the safety and feasibility of an outpatient protocol in Canada [8]
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