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

Novartis

Status: Completed

Conditions: Neuroendocrine Tumor

Treatments: Drug: Lutetium-177 DOTATATE

Study type: Observational

Funder types: Industry

Identifiers

NCT05816720

CAAA601A1US08

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

31 participants in 3 patient groups

Initial treatment

Description:

Patients who received initial treatment with lutetium-177 DOTATATE

Treatment:

Drug: Lutetium-177 DOTATATE

Re-treatment

Description:

Patients who received re-treatment with lutetium-177 DOTATATE

Treatment:

Drug: Lutetium-177 DOTATATE

Additional re-treatment

Description:

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

Treatment:

Drug: Lutetium-177 DOTATATE