Clinical trial NCT05816720: Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Official title: Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to approximately 11 years
measure: Overall survival
timeFrame: Up to approximately 11 years
measure: Percentage of patients with treatment response
timeFrame: Up to approximately 11 years
Secondary outcomes:
measure: Number of patients with adverse events (AEs)
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in white blood cell (WBC) count
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in hemoglobin
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in absolute neutrophil count (ANC)
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in lymphocyte count
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in platelet count
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in alkaline phosphatase (ALP)
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in alanine aminotransferase (ALT)
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in aspartate aminotransferase (AST)
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in albumin
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in bilirubin
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in creatinine
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in estimated glomerular filtration rate (eGFR)
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in cromogranin A
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in pancreatic polypeptide
timeFrame: Up to approximately 11 years
measure: Mean change from baseline in pancreastatin
timeFrame: Up to approximately 11 years
measure: Number of patients who received other treatments prior to initial treatment with lutetium-177 DOTATATE
timeFrame: Prior to initial treatment with lutetium-177 DOTATATE
measure: Number of patients who received lutetium-177 DOTATATE, categorized by number of doses
timeFrame: Up to approximately 11 years
measure: Number of patients who received lutetium-177 DOTATATE, categorized by treatment stage
timeFrame: Up to approximately 11 years
measure: Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage
timeFrame: Up to approximately 11 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Excel Diagnostics & Nuclear Oncology Center
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: