Toxicity and Tolerability of ¹⁷⁷Lu-DOTA-TATE PRRT with a Modified Administered Activity Protocol in NETs of Variable Origin – A Phase 2 Registry Study

Title:Toxicity and Tolerability of ¹⁷⁷Lu-DOTA-TATE PRRT with a Modified Administered Activity Protocol in NETs of Variable Origin – A Phase 2 Registry Study

Volume: 15 Issue: 2

Author(s): Alireza Khatami *, Golmehr Sistani, Duncan E. K. Sutherland , Sarah DeBrabandere, Robert H. Reid and David T. Laidley

Affiliation:

• Division of Nuclear Medicine, Department of Medical Imaging, Western University, London, ON N645C1, Canada

Keywords: Toxicity, safety, neuroendocrine tumor, NET, PRRT, peptide receptor radionuclide therapy, DOTATAE, Lu-177.

Abstract:

Background: Peptide receptor radionuclide therapy (PRRT) has been recently approved for advanced, metastatic, or progressive neuroendocrine tumors (NETs).

Objective: This study reports the adverse events (AEs) observed with patient-tailored administered activity.

Methods: Fifty-two PRRT naive patients were treated with 177Lu-DOTATATE. The administered activity ranges between 2.78 and 5.55 GBq/cycle using the patient's unique characteristics (age, symptoms, blood work, and biomarkers).

Results: The protocol was well tolerated with the overwhelming majority of participants being forty- six (88%), completing all 4 induction therapy cycles. The median cumulative administered activity was 19.6 GBq (ranged 3.8-22.3 GBq). A total of 42/52 (81%) reported at least one symptom, and 43/52 (83%) had evidence of biochemical abnormality at enrollment that would meet grade 1 or 2 criteria for AEs. These symptoms only slightly increase with treatment to 50/52 (96%) and 51/52 (98%), respectively. The most common symptoms were mild fatigue (62%), shortness of breath (50%), nausea (44%), abdominal pain (38%), and musculoskeletal pain (37%). The most common biomarker abnormalities were mild anemia (81%), reduced estimated glomerular filtration rate (eGFR) (58%), increased alkaline phosphatase (ALP) (50%), and leukopenia (37%). Of critical importance, no 177Lu-DOTATATE related grade 3 or 4 AEs were observed.

Conclusion: Tailoring the administered activity of 177Lu-DOTATATE to the individual patient with a variety of NETs is both safe and well-tolerated. No patient developed severe grade 3 or 4 AEs. Most patients exhibit symptoms or biochemical abnormality before treatment and this only slightly worsens following induction therapy.

Cite this article as:

Khatami Alireza*, Sistani Golmehr, Sutherland E. K. Duncan, DeBrabandere Sarah, Reid H. Robert and Laidley T. David , Toxicity and Tolerability of ¹⁷⁷Lu-DOTA-TATE PRRT with a Modified Administered Activity Protocol in NETs of Variable Origin – A Phase 2 Registry Study, Current Radiopharmaceuticals 2022; 15 (2) . https://dx.doi.org/10.2174/1874471014666210810100435