Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

Study Overview
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Brief Summary
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This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics & Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment. The study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first): Date of death - the date at which a patient was reported in the database as having died Last month active - the last recorded mention of the patient in the dataset End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.

Official Title
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Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

Conditions
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Neuroendocrine Tumor

Intervention / Treatment
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* Drug: Lutetium-177 DOTATATE


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Diagnosis of any NET Evidence of re-treatment with lutetium-177 DOTATATE Documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 DOTATATE, followed by evidence of progression, and then ≥1 subsequent dose of lutetium-177 DOTATATE Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose Exclusion criteria • <18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Initial treatment<br>Patients who received initial treatment with lutetium-177 DOTATATE | Drug: Lutetium-177 DOTATATE<br>* Intravenous administration<br>* Other names: Lutathera®;|
| Re-treatment<br>Patients who received re-treatment with lutetium-177 DOTATATE | Drug: Lutetium-177 DOTATATE<br>* Intravenous administration<br>* Other names: Lutathera®;|
| Additional re-treatment<br>Patients who received additional re-treatment with lutetium-177 DOTATATE | Drug: Lutetium-177 DOTATATE<br>* Intravenous administration<br>* Other names: Lutathera®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death | Up to approximately 11 years | 
| Overall survival | Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death | Up to approximately 11 years | 
| Percentage of patients with treatment response | Best overall response was defined per Response Evaluation Criteria In Solid Tumors (RECIST), 1.1. Overall response: complete response (CR) + partial response (PR); CR; PR; stable disease (SD); and progressive disease (PD) | Up to approximately 11 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events (AEs) |  | Up to approximately 11 years | 
| Mean change from baseline in white blood cell (WBC) count |  | Up to approximately 11 years | 
| Mean change from baseline in hemoglobin |  | Up to approximately 11 years | 
| Mean change from baseline in absolute neutrophil count (ANC) |  | Up to approximately 11 years | 
| Mean change from baseline in lymphocyte count |  | Up to approximately 11 years | 
| Mean change from baseline in platelet count |  | Up to approximately 11 years | 
| Mean change from baseline in alkaline phosphatase (ALP) |  | Up to approximately 11 years | 
| Mean change from baseline in alanine aminotransferase (ALT) |  | Up to approximately 11 years | 
| Mean change from baseline in aspartate aminotransferase (AST) |  | Up to approximately 11 years | 
| Mean change from baseline in albumin |  | Up to approximately 11 years | 
| Mean change from baseline in bilirubin |  | Up to approximately 11 years | 
| Mean change from baseline in creatinine |  | Up to approximately 11 years | 
| Mean change from baseline in estimated glomerular filtration rate (eGFR) |  | Up to approximately 11 years | 
| Mean change from baseline in cromogranin A |  | Up to approximately 11 years | 
| Mean change from baseline in pancreatic polypeptide |  | Up to approximately 11 years | 
| Mean change from baseline in pancreastatin |  | Up to approximately 11 years | 
| Number of patients who received other treatments prior to initial treatment with lutetium-177 DOTATATE |  | Prior to initial treatment with lutetium-177 DOTATATE | 
| Number of patients who received lutetium-177 DOTATATE, categorized by number of doses |  | Up to approximately 11 years | 
| Number of patients who received lutetium-177 DOTATATE, categorized by treatment stage |  | Up to approximately 11 years | 
| Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage |  | Up to approximately 11 years |