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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial treatment | Patients who received initial treatment with lutetium-177 DOTATATE |
| |
| Re-treatment | Patients who received re-treatment with lutetium-177 DOTATATE |
| |
| Additional re-treatment | Patients who received additional re-treatment with lutetium-177 DOTATATE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutetium-177 DOTATATE | Drug | Intravenous administration |
|
| 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 |
| 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 | |
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Inclusion criteria
Diagnosis of any NET
Evidence of re-treatment with lutetium-177 DOTATATE
Exclusion criteria
• <18 years of age
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This was a retrospective, noninterventional cohort study
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excel Diagnostics & Nuclear Oncology Center | Houston | Texas | 77042 | United States |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C447941 | lutetium Lu 177 dotatate |
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| 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 |
| D009380 | Neoplasms, Nerve Tissue |