Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
- Registration Number
- NCT05816720
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Re-treatment Lutetium-177 DOTATATE Patients who received re-treatment with lutetium-177 DOTATATE Initial treatment Lutetium-177 DOTATATE Patients who received initial treatment with lutetium-177 DOTATATE Additional re-treatment Lutetium-177 DOTATATE Patients who received additional re-treatment with lutetium-177 DOTATATE
- Primary Outcome Measures
Name Time Method 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
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)
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
- Secondary Outcome Measures
Name Time Method Mean change from baseline in alanine aminotransferase (ALT) Up to approximately 11 years Mean change from baseline in creatinine Up to approximately 11 years Mean change from baseline in hemoglobin Up to approximately 11 years Mean change from baseline in alkaline phosphatase (ALP) 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 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 lymphocyte count Up to approximately 11 years Mean change from baseline in platelet count 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 absolute neutrophil count (ANC) Up to approximately 11 years Mean change from baseline in aspartate aminotransferase (AST) 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 Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage Up to approximately 11 years Mean change from baseline in estimated glomerular filtration rate (eGFR) Up to approximately 11 years 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
Trial Locations
- Locations (1)
Excel Diagnostics & Nuclear Oncology Center
🇺🇸Houston, Texas, United States