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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Lines of Therapy (LOTs) | Up to approximately 8 years | |
| Number and Percentage of Patients by Treatment Regimen per LOT | Up to approximately 8 years | |
| Number and Percentage of Patients by Type of Therapy in Each LOT | Up to approximately 8 years | |
| Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen | Up to approximately 8 years | |
| Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation | Up to approximately 8 years | |
| Time to 1L Treatment Discontinuation | Up to approximately 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration Between GEP-NET Diagnosis and 1L Treatment | Baseline | |
| Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment | Up to approximately 8 years | |
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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.
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.
Patients ≥18 years of age on the index date
Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:
Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:
Exclusion criteria:
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Patients with evidence of a GEP-NET diagnosis between 01 January 2018 and 31 December 2025 and initiating a 1L treatment during this time period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Recruiting | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
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| Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy |
| Up to approximately 8 years |
| Time to Next Treatment (TTNT) | Up to approximately 8 years |
| Overall Survival (OS) | OS calculated as the number of weeks from the start of treatment until death. | Up to approximately 8 years |
| Number and Percentage of Patients by Demographics | Demographics include:
| Baseline |
| Age | Baseline |
| Duration of Follow-up | Up to approximately 8 years |
| Number and Percentage of Patients by Clinical Characteristics | Clinical characteristics include:
| Baseline |
| NCI Comorbidity Index Score | The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score (from 1 to 6) based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death. | Baseline |