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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuroendocrine Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Initial treatment

Patients who received initial treatment with lutetium-177 DOTATATE

Lutetium-177 DOTATATE

Intervention Type DRUG

Intravenous administration

Re-treatment

Patients who received re-treatment with lutetium-177 DOTATATE

Lutetium-177 DOTATATE

Intervention Type DRUG

Intravenous administration

Additional re-treatment

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

Lutetium-177 DOTATATE

Intervention Type DRUG

Intravenous administration

Interventions

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Lutetium-177 DOTATATE

Intravenous administration

Intervention Type DRUG

Other Intervention Names

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Lutathera®

Eligibility Criteria

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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