Practical Considerations for Implementation of 177Lu-DOTATATE Neuroendocrine Tumor Treatment Programs

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FIGURE 1.
¹⁷⁷Lu-DOTATATE PRRT administration time line.
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FIGURE 2.
¹⁷⁷Lu-DOTATATE Rotterdam secondary pump infusion method. IV = intravenous; Radio Rx = ¹⁷⁷Lu-DOTATATE; USP = U.S. Pharmacopeia.
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FIGURE 3.
Example of discordant uptake on ¹⁸F-FDG and ⁶⁸Ga-DOTATOC imaging. Two lesions are visualized: left inguinal node (¹⁸F-FDG–positive, minimal ⁶⁸Ga-DOTATOC uptake) and left ischium bone lesion (⁶⁸Ga-DOTATOC–positive, ¹⁸F-FDG–negative).
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FIGURE 4.
PET/CT imaging 1 h after injection of ⁶⁸Ga-DOTATATE, and SPECT/CT imaging 96 h after injection of ¹⁷⁷Lu-DOTATATE. p.i. = after injection.

TABLE 1.

PRRT Exclusion Criteria Considerations (19)

Parameter	Exclusion criterion
Serum creatinine	>150 μmol/L (>1.7 mg/dL) or creatinine clearance < 50 mL/min
Hemoglobin	<5.0 mmol/L (<8.0 g/dL)
White-cell count	<2,000/mm³ (2 × 10⁹/L)
Platelet count	<75,000/mm³ (75 × 10⁹/L)
Total bilirubin	>3 times upper limit of reference range
Serum albumin	<25 g/L and prothrombin time increased 1.5 times upper limit of reference range*

TABLE 2.

Classification and Grading Criteria for Neuroendocrine Neoplasms of Gastrointestinal Tract and Hepatopancreatobiliary Organs (21)

Terminology	Differentiation	Grade	Mitotic rate	Ki-67 index
NET, grade 1	Well differentiated	Low	<2	<3%
NET, grade 2	Well differentiated	Intermediate	2–20	3%–20%
NET, grade 3	Well differentiated	High	>20	>20%
NEC, small-cell type	Poorly differentiated	High^*	>20	>20%
NEC, large-cell type	Poorly differentiated	High^*	>20	>20%
MiNEN	Well or poorly differentiated	Variable^†	Variable^†	Variable^†

↵* Poorly differentiated neuroendocrine carcinomas are not formally graded but are considered high-grade.
↵† In most mixed neuroendocrine–nonneuroendocrine neoplasms, both neuroendocrine and nonneuroendocrine components are poorly differentiated, and neuroendocrine component has proliferation indices in same range as other neuroendocrine carcinomas, but this conceptual category allows for possibility that one or both components may be well differentiated; when feasible, each component should therefore be graded separately.
MiNEN = mixed neuroendocrine–nonneuroendocrine neoplasm; NEC = neuroendocrine carcinoma.
Mitotic rates are number of mitoses/2 mm² as determined by counting 50 fields of 0.2 mm² (i.e., in total area of 10 mm²); Ki-67 proliferation index value is determined by counting at least 500 cells in regions of highest labeling (hot spots), which are identified at scanning magnification; final grade is based on whichever of 2 proliferation indices places neoplasm in higher-grade category.