BRAF-positive Metastatic Melanoma
Conditions
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.
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 (ICD-9 172x & ICD-10 C43 or D03x) * ≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011 * Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011 * Diagnosis of MM after 01 January 2011 * Evidence of a BRAF-positive result at any point in time * Treatment with one of the following 1L therapies on or after 01 January 2014: * IO (nivolumab, pembrolizumab, or ipilimumab + nivolumab) * TT (dab/tram) * At least 18 years of age at the time of initiation of 1L therapy * At least 6-months of continuous follow-up from the time of initiation of 1L therapy
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean age of 1L dab/tram-treated BRAF+ MM patients | Baseline | — |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex | Baseline | — |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category | Baseline | — |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category | Baseline | — |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region | Baseline | — |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice | Baseline | — |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type | 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 | 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). |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site | Baseline | — |
| Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients | Baseline | — |
| Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients | Baseline | — |
| Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients | Baseline | — |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy | Up to approximately 2 years | — |
| Time from the start of 1L dab/tram therapy until the start of 2L therapy | Up to approximately 2 years | — |
| Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients | 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. |
| Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients | Up to approximately 2 years | OS was defined as the time from the start of 1L dab/tram therapy until death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time patients remained on 1L IO therapy following disease progression | 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 | rwPFS was defined as the time from the first disease progression until next progression or death from any cause. |
| Time from the first disease progression until the start of 2L therapy | Up to approximately 2 years | — |
| Time from the start of 1L IO until the start of 2L therapy | Up to approximately 2 years | — |
| Mean age of 1L IO-refractory patients with BRAF+ MM | Baseline | — |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex | Baseline | — |
| 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 | — |
| 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 | — |
| OS for 1L IO-refractory patients with BRAF+ MM | Up to approximately 2 years | OS was defined as the time from the first disease progression until death from any cause. |
| 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 with an ECOG score of 0, 1, 2, 3, or 4 | 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). |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site | 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 | — |
| 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 proportion of patients remaining on 1L IO therapy following disease progression | Up to approximately 2 years | — |
Countries
United States
Outcome results
None listed