Esophageal Adenocarcinoma, Gastric Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma
Conditions
Keywords
Esophageal Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
Brief summary
This study uses existing cancer registry and health record data to understand how nivolumab is used in routine care in the Netherlands for adults with advanced cancers of the esophagus, gastroesophageal junction, or stomach.
Interventions
DRUGNivolumab
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Registered in the Netherlands Cancer Registry (NCR) * Diagnosed with Esophageal Adenocarcinoma (EAC), Gastro-esophageal Junction Adenocarcinoma (GEJAC), or Gastric Adenocarcinoma (GAC) from 01-Aug-2022 to 31-Jul-2024 * Age ≥18 years at diagnosis * Unresectable advanced (cT4B) or synchronous metastatic (cM1) disease at diagnosis * (Cohort 2) Programmed cell Death Ligand 1 (PD-L1) CPS ≥5 * (Cohort 3) Received nivolumab as part of first-line treatment
Exclusion criteria
* Neuro-endocrine carcinomas or non-epithelial cancers of esophagus/ gastroesophageal junction /stomach * Positive HER2 expression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) among participants treated with first-line nivolumab | Up to 24 months | Time from start of first-line nivolumab to death from any cause among participants in Cohort 3. Associations between baseline demographic, clinical, and treatment characteristics and overall survival will be evaluated using Cox proportional hazards models. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who underwent Programmed cell Death Ligand 1 (PD-L1) testing prior to treatment initiation | Baseline | Associations between baseline demographic and clinical characteristics and likelihood of PD-L1 testing will be evaluated using logistic regression models. |
| Number of participants by Programmed cell Death Ligand 1 (PD-L1) diagnostic antibody | Baseline | — |
| Number of participants tested for Programmed cell Death Ligand1 (PD-L1) who meet Combined Positive Score (CPS) thresholds | Baseline | — |
| Number of participants eligible for first-line nivolumab treatment | Baseline | — |
| Number of eligible participants who received first-line nivolumab treatment | Up to 24 months | Associations between baseline demographic and clinical characteristics and receipt of first-line nivolumab will be evaluated using logistic regression models. |
Countries
Netherlands
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed