Amino Acid Solutions for (177)Lu-Oxodotreotide Premedication: A Tolerance Study

SIMPLE SUMMARY: [(177)Lu]oxodotreotide (Lutathera(®)) was approved by the European Medical Agency in 2017 and the Food and Drug Administration in 2018 for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors as the first radiopharmaceutical for peptide receptor radionuclide therapy (PRRT). PRRT premedication using an amino acid solution is the standard regimen for renal protection. In this way, our nuclear medicine department used two types of amino acid perfusion. Firstly, a commercial solution containing a mixture of amino acids and, next, a lysine–arginine preparation. We aimed to estimate the tolerance profile and risk factors of adverse events with both solutions. In our large cohort of patients (76 patients for 236 cycles), we confirmed the better tolerance of the lysine–arginine preparation. The risk factors identified were being of the female sex and the use of the commercial solution. To our knowledge, this is the first study to evaluate the tolerance of amino acid solutions with real-life patient data in a large cohort. ABSTRACT: Background: The co-infusion of amino acid solutions during peptide receptor radionuclide therapy reduces the tubular reabsorption of (177)Lu-oxodotreotide, thus minimizing nephrotoxicity. In our nuclear medicine department, the patients received two different types of amino acid perfusion over time: a commercial solution (CS) containing 10% amino acids, and a 2.5% lysine–arginine (LysArg) hospital preparation, produced by a referral laboratory. The aim of the present study was to analyze the tolerance of the two amino acid solutions. Methods: The patient files were analyzed and double-checked. The study parameters comprised the gender, age, primary tumor site, type of amino acid perfusion, adverse events (AE) and WHO AE grades, antiemetic premedication, creatinine, and serum potassium level. Results: From February 2016 to February 2019, 76 patients were treated, for a total 235 cycles. AEs occurred in 71% of the CS cycles (n = 82/116), versus 18% (n = 21/119) in the LysArg group (p < 0.0001). In the CS group, the AEs were mostly WHO grade 4 (n = 24/82), and mostly grade 1 in the LysArg group (n = 13/21). Poisson regression showed a higher risk of AE overall and of grades 3 and 4 in the females and with CS. The mean creatinine clearance was identical before and after the PRRT cycles, whichever amino acid perfusion was used. Conclusions: The lysine–arginine preparation showed better tolerance than the commercial solution. The change to LysArg reduced the antiemetic premedication from four molecules to one.