Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- BRAF-positive Metastatic Melanoma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 785
- Locations
- 1
- Primary Endpoint
- Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x & ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the Flatiron Health database
- •Evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar)
- •Documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1L treatment
- •Presence of leptomeningeal disease (ICD-9 198.4 \& ICD-10 C79.32 or C79.49)
Outcomes
Primary Outcomes
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category
Time Frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category
Time Frame: Baseline
Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients
Time Frame: Baseline
Mean age of 1L dab/tram-treated BRAF+ MM patients
Time Frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice
Time Frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type
Time Frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site
Time Frame: Baseline
Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients
Time Frame: Up to approximately 2 years
OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.
Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex
Time Frame: Baseline
Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients
Time Frame: Up to approximately 2 years
rwPFS was defined as the time from the start of 1L dab/tram therapy until first progression or death from any cause.
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region
Time Frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, 3, or 4
Time Frame: Baseline
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients
Time Frame: Baseline
Time from the start of 1L dab/tram therapy until the start of 2L therapy
Time Frame: Up to approximately 2 years
Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients
Time Frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy
Time Frame: Up to approximately 2 years
Secondary Outcomes
- Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type(Baseline)
- Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site(Baseline)
- Time patients remained on 1L IO therapy following disease progression(Up to approximately 2 years)
- Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex(Baseline)
- Number and proportion of patients remaining on 1L IO therapy following disease progression(Up to approximately 2 years)
- Number and percentage of 1L IO-refractory patients with BRAF+ MM with an ECOG score of 0, 1, 2, 3, or 4(Baseline)
- Time from the start of 1L IO until the start of 2L therapy(Up to approximately 2 years)
- Time from the first disease progression until the start of 2L therapy(Up to approximately 2 years)
- OS for 1L IO-refractory patients with BRAF+ MM(Up to approximately 2 years)
- Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region(Baseline)
- Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice(Baseline)
- Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM(Up to approximately 2 years)
- Number and percentage of patients treated with 2L therapy, overall and by therapy type(Up to approximately 2 years)
- rwPFS for 1L IO-refractory patients with BRAF+ MM(Up to approximately 2 years)
- Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category(Baseline)
- Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category(Baseline)
- Mean age of 1L IO-refractory patients with BRAF+ MM(Baseline)
- Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM(Baseline)
- Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM(Baseline)
- Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM(Baseline)