Gastroenteropancreatic Neuroendocrine Tumor
Conditions
Keywords
Real-world evidence, Treatment patterns, Lutathera
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
1. 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
1. 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)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) | Up to approximately 8 years | OS calculated as the number of weeks from the start of treatment until death. |
| Number and Percentage of Patients by Demographics | Baseline | Demographics include: * Age group (18-34, 35-44, 45-54, 55-64, 65+ years) * Sex * Geographic region * Payer type * Race/ethnicity * Education level * Occupation * Marital status |
| Age | Baseline | — |
| Duration of Follow-up | Up to approximately 8 years | — |
| Number and Percentage of Patients by Clinical Characteristics | Baseline | Clinical characteristics include: * National Cancer Institute (NCI) comorbidity index category (0, 1, 2, 3+) * Comorbidities * Treating provider specialty * Metastatic sites (bone, visceral, lymph node, liver) * Number of distinct metastatic sites (0, 1, 2, 3, 4+) |
| NCI Comorbidity Index Score | Baseline | 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. |
Countries
United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed