Melanoma
Conditions
Brief summary
This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy \[IO\], or targeted therapy \[TT\] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.
Interventions
DRUGNivolumab
Patients receiving nivolumab
Patients receiving ipilimumab + nivolumab
DRUGPembrolizumab
Patients receiving pembrolizumab
Dabrafenib + trametinib
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
* Patients with at least one diagnosis of malignant melanoma of skin anytime from the start of data collection until the start of study period. * Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy. * The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma. * Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib. * At least 18 years of age at the time of adjuvant treatment initiation. * Patients with at least 6 months of continuous enrollment prior to the index date. * Patients with at least 6 months of continuous enrollment after the index date. * If necessary, there were additional criteria of absence of secondary malignancy (including metastatic site).
Exclusion criteria
* Patients with a diagnosis of non-melanoma primary malignancy during the 6 months pre-index period. * Patients with chemotherapy or interferon alpha before index date. * Patients with pregnancy any time during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients on first systemic adjuvant therapy with adverse avents (AEs) | Up to approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation. | Up to approximately 5 years |
| Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy | Up to approximately 5 years |
| Healthcare costs associated with AEs on first systemic adjuvant therapy | Up to approximately 5 years |
| HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation | Up to approximately 5 years |
| Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation | Up to approximately 5 years |
Countries
United States
Outcome results
None listed