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

NCT05816720 | Completed

• 1 other identifier: CAAA601A1US08
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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. 1.Date of death - the date at which a patient was reported in the database as having died
2. 2.Last month active - the last recorded mention of the patient in the dataset
3. 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.

Conditions

Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (20)

• 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

Study Arms (3)

Initial treatment

Patients who received initial treatment with lutetium-177 DOTATATE

Drug: Lutetium-177 DOTATATE

Re-treatment

Patients who received re-treatment with lutetium-177 DOTATATE

Drug: Lutetium-177 DOTATATE

Additional re-treatment

Patients who received additional re-treatment with lutetium-177 DOTATATE

Drug: Lutetium-177 DOTATATE

Interventions

Lutetium-177 DOTATATE DRUG

Intravenous administration

Also known as: Lutathera®

Additional re-treatment; Initial treatment; Re-treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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

You may not qualify if:

• \<18 years of age

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: April 18, 2023
• Study Start: September 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)