177-Lu Dotatate Therapy Administration
- Perform procedure with patient in hospital for 24 h.
- Refer to Dose Estimation for the activity to give. Keep cumulative bone marrow radiation dose below 2 Gy and kidney's below 23 Gy (approximately with total maximun dose: 800 mCi or 30 GBq).
- Install iv line 1: In 4-8 h pass 8,5% aminoacid solution 1500 ml, plus 30 ml 10%. magnesium sulfate, plus 500 ml lactate ringer, starting 30-60 min before 177-Lu dotatate administration. At the beggining ondansetron 8 mg iv and dexamethasone 4 mg iv as well, must be given to diminish nausea and vomiting. For the latter in some patients is more effective and better tolerated, 100 ml saline plus 10 mg domperidone, every 8 h or 6 h to run in 1 h to 4 h.
- Install iv line 2: Saline solution. Thirty to sixty min after starting solution 1, administer labeled dotatate diluted in 250 ml saline in 30 min to 60 min, afterwards, keep solution 1 running till finishing.
- At 24 h and before discharge, obtain a whole body image and spect of thorax and abdomen, using 177Lu 208 keV and 113 keV photons window width 20% and parallel-hole medium-energy or high energy general-purpose collimator.
- Detail in written form radiation protection directions to patient.
- Non labeled somatostatin (e.g. Sandostatin) treatment may be resumed 3-5 days after this therapy, to ease carcinoid syndrome symptoms.
In the Strosberg J. et al. publication,
Key exclusion criteria were a serum creatinine level of more than 150 μmol per liter (1.7 mg per deciliter) or a creatinine clearance of less than 50 ml per minute; a hemoglobin level of less than 8.0 g per deciliter; a white-cell count of less than 2000 per cubic millimeter; a platelet count of less than 75,000 per cubic millimeter; a total bilirubin level of more than 3 times the upper limit of the normal range; a serum albumin level of less than 3.0 g per deciliter, unless the prothrombin time value was within the normal range; treatment with more than 30 mg of octreotide LAR within 12 weeks before randomization; peptide receptor radionuclide therapy at any time before randomization; and any surgery, liver directed transarterial therapy, or chemotherapy within 12 weeks before randomization.
In the 177 Lu-Dotatate group, 7.4 GBq (200 mCi) of 177 Lu-Dotatate was infused intravenously over a period of 30 minutes. Patients received four infusions every 8 weeks (cumulative radioactivity, 29.6 GBq [800 mCi]) unless unacceptable toxic effects occurred, centrally confirmed disease progression (according to RECIST) was present on imaging, the patient was unable or unwilling to adhere to trial procedures, the patient withdrew consent, or the patient died. For renal protection, an intravenous amino acid solution (Aminosyn II 10% [21.0 g of lysine and 20.4 g of arginine in 2 liters of solution] or VAMIN-18 [18 g of lysine and 22.6 g of arginine in 2 liters of solution]) was administered concomitantly for at least 4 hours, starting 30 minutes before infusion of the radiopharmaceutical. In the 177 Lu- Dotatate group, patients continued to receive supportive care with octreotide LAR, which was administered intramuscularly at a dose of 30 mg approximately 24 hours after each infusion of 177 Lu-Dotatate and then monthly after completion of all four treatments.
References:
1 Kwekkeboom Dik J et al. Treatment With the Radiolabeled Somatostatin Analog [177Lu-DOTA0,Tyr3]Octreotate: Toxicity, Efficacy, and Survival. J Clin Oncol 2008; 26: 2124-2130.
2 Reubi J. C. et al. Affinity profiles for human somatostatin receptor subtypes SST1–SST5 of somatostatin radiotracers selected for scintigraphic and radiotherapeutic use. Eur J Nucl Med 2000; 27:273–282.
3 Esser JP et al. Comparison of [177Lu-DOTA0,Tyr3]octreotate and [177Lu-DOTA0, Tyr3]octreotide: which peptide is preferable for PRRT ?. Eur J Nucl Med Mol Imaging (2006) 33:1346–1351.
4 Strosberg J. et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med 2017;376:125-35. DOI: 10.1056/NEJMoa1607427.
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