A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
Purpose
This study aims to characterize current treatment patterns and clinical outcomes among newly diagnosed GEP-NET patients in the United States using open-source Longitudinal Prescription Claims (LRx) and Patient Centric Medical Claims (Dx) databases supplemented with mortality data.
Condition
- Gastroenteropancreatic Neuroendocrine Tumor
Eligibility
- Eligible Ages
- Between 18 Years and 110 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients with ≥1 International Classification of Diseases Clinical Modification, 10th revision (ICD-10-CM) diagnosis code for GEP-NET between 01 January 2018 and 31 December 2025. The date of the first such claim will be defined as the diagnosis date. 2. Initiation of first-line (1L) systemic therapy (i.e., somatostatin analogs [SSAs], targeted therapy, peptide receptor radionuclide therapy [PRRT], chemotherapy) indicated for GEP-NET on or after the date of diagnosis. The date of treatment initiation will be defined as the index date. 3. Patients ≥18 years of age on the index date 4. Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as: 1. ≥1 medical and pharmacy claim >12 months prior to the index date; AND 2. ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND 3. ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND 5. Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as: 1. ≥ 1 pharmacy dispensing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date 2. ≥ 1 provider prescribing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date
Exclusion Criteria
- Patients with evidence of GEP-NET prior to the diagnosis date within the study period 2. Patients with evidence of GEP-NET treatment prior to the index date within the study period 3. Patients with missing or invalid age or sex 4. Patients with other primary malignancies during the 12-month pre-index period 5. Patients with invalid death date (i.e., death date ≤ index date)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Overall GEP-NET Cohort | Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025. | |
| 1L Lutetium Lu 177 Dotatate Cohort | A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L lutetium Lu 177 dotatate. | |
| 1L Capecitabine + Temozolomide (CAPTEM) Cohort | A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L CAPTEM. | |
| 1L Cabozantinib Cohort | A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L cabozantinib. | |
| Lutetium Lu 177 Dotatate Cohort | A subgroup of the Overall GEP-NET Cohort. Patients receiving lutetium Lu 177 dotatate in 2L or later settings. | |
| CAPTEM Cohort | A subgroup of the Overall GEP-NET Cohort. Patients receiving CAPTEM in 2L or later settings. | |
| Cabozantinib Cohort | A subgroup of the Overall GEP-NET Cohort. Patients receiving cabozantinib in 2L or later settings. |
Recruiting Locations
Novartis
East Hanover, New Jersey 07936
East Hanover, New Jersey 07936
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals