Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

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.

Study Overview

• Status: Completed
• Conditions: Neuroendocrine Tumor
• Intervention / Treatment: Drug: Lutetium-177 DOTATATE

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77042
      • Excel Diagnostics & Nuclear Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Initial treatment; Patients who received initial treatment with lutetium-177 DOTATATE	Drug: Lutetium-177 DOTATATE; Intravenous administration; Other Names: Lutathera®
Re-treatment; Patients who received re-treatment with lutetium-177 DOTATATE	Drug: Lutetium-177 DOTATATE; Intravenous administration; Other Names: Lutathera®
Additional re-treatment; Patients who received additional re-treatment with lutetium-177 DOTATATE	Drug: Lutetium-177 DOTATATE; Intravenous administration; Other Names: Lutathera®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Lutetium Lu 177 dotatate
• Other Study ID Numbers: CAAA601A1US08