Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Novartis

Status

Completed

Conditions

Melanoma

Treatments

Drug: Dabrafenib + trametinib

Drug: Ipilimumab + nivolumab

Drug: Nivolumab

Drug: Pembrolizumab

Study type

Observational

Funder types

Industry

Identifiers

NCT05714371

CTMT212AUS57

Details and patient eligibility

About

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.

Enrollment

618 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.