Esophageal Cancer, Gastroesophageal Junction Cancer
Conditions
Keywords
Esophageal Cancer (EC), Gastroesophageal Junction Cancer (GEJC)
Brief summary
The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) in China.
Interventions
DRUGNivolumab
As per product label, as prescribed by treating physician
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
* Participants aged 18 years or older at the index date * All patients must have Stage II or Stage III carcinoma of the esophagus or gastroesophageal junction and have histologically or cytologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer at the time of initial diagnosis. * Participants initiated nivolumab in adjuvant Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) treatment within the index window.
Exclusion criteria
* Participation in a clinical trial of an investigational drug concurrently during the adjuvant nivolumab treatment. * From the date of diagnosis of EC or GJEC to data end period, patients were diagnosed with a primary diagnosis of a cancer other than EC or GJEC that requires systemic or other treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant disease-free survival (DFS) | Up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Date of nivolumab treatment completion/discontinuation | Up to 1 year | — |
| Nivolumab treatment regimen | Up to 1 year | — |
| Participant concomitant treatment(s) | Baseline and up to 1 year | — |
| Participant socio-demographics | Baseline and up to 1 year | — |
| Date of tumor initial diagnosis | Baseline | — |
| Tumor location at initial diagnosis | Baseline | — |
| Tumor histology at initial diagnosis | Baseline | — |
| Resected tumor margins status | Baseline | Negative (clear), positive (involved), close margins |
| Eastern Cooperative Oncology Group (ECOG) performance status | Baseline and up to 1 year | — |
| Pathological lymph-node status | Baseline and up to 1 year | — |
| Pathological tumor status | Baseline and up to 1 year | — |
| Participant biomarkers (if available) | Baseline and up to 1 year | Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis |
| Participant systemic treatment(s) | Up to 1 year | — |
| Participant medical history | Baseline and up to 1 year | — |
| Participant cancer treatment history | Baseline | — |
| Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation | Day 1 | — |
| Indication for nivolumab treatment | Day 1 | — |
| Nivolumab treatment duration | Up to 1 year | — |
| Time from surgery to nivolumab initiation | Day 1 | — |
| Reasons for treatment discontinuation/cessation | Up to 1 year | — |
| Subsequent treatment after nivolumab discontinuation | Up to 1 year | — |
| Time to next treatment (TTNT) | Up to 1 year | — |
| Nivolumab treatment modifications in relation to the management of adverse events (AE) | Up to 1 year | — |
| Participant distant metastasis-free survival (DMFS) | Up to 1 year | — |
| Participant distant metastasis-free survival (DMFS) rates | Up to 1 year | — |
| Participant outcomes after nivolumab treatment | Baseline and up to 1 year | Including disease stage, recurrence, disease progression, medical imaging test result, and death information |
Countries
China
Outcome results
None listed