TABLE 1:

Indications for Cessation of ¹⁷⁷Lu-DOTATATE or ¹⁷⁷Lu-Vipivotide Tetraxetan Therapy After Toxicity Develops

Therapy and Toxicity	Indication for Cessation
l77Lu- DOTATATEa
Thrombocytopenia	Recurrent grade 2, 3, or 4 AE after withholding of agent until complete or partial resolution (grade 0 or 1 AE) and restarting at a reduced dose Permanently discontinue if grade 2 or greater thrombocytopenia results in a delay of 16 wk or more
Anemia and neutropenia	Recurrent grade 3 or 4 AE after withholding of agent until complete or partial resolution (grade 0, 1, or 2 AE) and restarting at a reduced dose Permanently discontinue if grade 3 or greater anemia or neutropenia results in a delay of 16 wk or more
Renal toxicity	Recurrent renal toxicity after withholding of agent until complete resolution or return to baseline and restarting at a reduced dose Permanently discontinue if renal toxicity results in a delay 16 wk or more
Hepatotoxicity	Recurrent hepatotoxicity after withholding of agent until complete resolution or return to baseline and restarting at a reduced dose Permanently discontinue if hepatotoxicity results in a delay 16 wk or more
Any other possibly related CTCAE grade 3 or grade 4 AE	Recurrent grade 3 AE after dose reduction after withholding of agent until complete or partial resolution (grade 0, 1, or 2 AE) and restarting at a reduced dose Permanently discontinue for grade 3 or greater AE that results in a delay 16 wk or more
l77Lu–vipivotide tetraxetanb
Myelosuppression	Recurrent grade 3 or greater AE after one dose reduction
Renal toxicity	Grade 3 or greater AE Recurrent renal toxicity after one dose reduction
Xerostomia	Grade 3 or greater AE
Gastrointestinal toxicity	Grade 3 or greater AE (not amenable to medical intervention) Recurrent grade 3 or greater AE after one dose reduction
Transaminitis	Five times upper limit of normal, in the absence of hepatic metastases
Nonhematologic toxicity	Any unacceptable toxicity Any serious AE that delays therapy more than 4 wk Any grade 3 or 4 AE or persistent intolerable grade 2 AE after one dose reduction

Note—AE = adverse event, CTCAE = Common Terminology Criteria for Adverse Events.

^aInformation derived from [73].

^binformation derived from [35].