BRAF Positive Metastatic Melanoma
Conditions
Brief summary
This was a retrospective real-world evidence cohort study.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of melanoma (The International Classification of Diseases, 9th Revision \[ICD-9\] 172.x & 10th revision \[ICD-10\] C43 or D03x). * Pathologic stage IV at initial diagnosis on or after 01 January 2011. * First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014. * Evidence of a BRAF test. * Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation. * At least 18 years of age at the time of initiation of 1L treatment.
Exclusion criteria
* Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014. * Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of metastatic sites | Baseline | — |
| Eastern Cooperative Oncology Group performance status (ECOG PS) | Baseline | The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled. |
| Number of patients with study-related biomarkers | Baseline | Study-related biomarkers included BRAF and PD1/PDL1 test dates and results. |
| Mean age | Baseline | — |
| Number of male patients | Baseline | — |
| Race | Baseline | — |
| Mean Charlson comorbidity index (CCI) score | Baseline | Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 6 months and 1, 1.5, and 2 years | OS was defined as the time from the initiation of a line of therapy until death from any cause. |
| Progression-free survival (PFS) | 6 months and 1, 1.5, and 2 years | PFS was defined as the time from the initiation of a line of therapy until the date of progression or death. |
Countries
United States
Outcome results
None listed