Neuroendocrine Tumor
Conditions
Brief summary
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): 1. Date of death - the date at which a patient was reported in the database as having died 2. Last month active - the last recorded mention of the patient in the dataset 3. 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.
Interventions
DRUGLutetium-177 DOTATATE
Intravenous administration
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to approximately 11 years | Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death |
| Overall survival | Up to approximately 11 years | Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death |
| Percentage of patients with treatment response | Up to approximately 11 years | 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of patients with adverse events (AEs) | 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 |
| Mean change from baseline in creatinine | 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 |
Countries
United States
Outcome results
None listed