Clinical trial NCT05714371: Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
Official title: Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients on first systemic adjuvant therapy with adverse avents (AEs)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation.
timeFrame: Up to approximately 5 years
measure: Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy
timeFrame: Up to approximately 5 years
measure: Healthcare costs associated with AEs on first systemic adjuvant therapy
timeFrame: Up to approximately 5 years
measure: HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation
timeFrame: Up to approximately 5 years
measure: Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: