Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 785
- 试验地点
- 1
- 主要终点
- Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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)
结局指标
主要结局
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category
时间窗: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category
时间窗: Baseline
Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients
时间窗: Baseline
Mean age of 1L dab/tram-treated BRAF+ MM patients
时间窗: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice
时间窗: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type
时间窗: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site
时间窗: Baseline
Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients
时间窗: 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
时间窗: Baseline
Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline
Time from the start of 1L dab/tram therapy until the start of 2L therapy
时间窗: Up to approximately 2 years
Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients
时间窗: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy
时间窗: Up to approximately 2 years
次要结局
- 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)