Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Study Details
Study Description
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):
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Date of death - the date at which a patient was reported in the database as having died
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Last month active - the last recorded mention of the patient in the dataset
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Initial treatment Patients who received initial treatment with lutetium-177 DOTATATE |
Drug: Lutetium-177 DOTATATE
Intravenous administration
Other Names:
|
| Re-treatment Patients who received re-treatment with lutetium-177 DOTATATE |
Drug: Lutetium-177 DOTATATE
Intravenous administration
Other Names:
|
| Additional re-treatment Patients who received additional re-treatment with lutetium-177 DOTATATE |
Drug: Lutetium-177 DOTATATE
Intravenous administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion criteria
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Diagnosis of any NET
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Evidence of re-treatment with lutetium-177 DOTATATE
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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
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Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose
Exclusion criteria
• <18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Excel Diagnostics & Nuclear Oncology Center | Houston | Texas | United States | 77042 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAAA601A1US08