Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients

Non-interventional Register-based Study to Analyze Patient Characteristics, Treatment Patterns and Healthcare Resource Utilization in Adult Patients With Metastatic Melanoma

This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district.

Study Overview

• Status: Completed
• Conditions: Metastatic Melanoma

• Study Type: Observational
• Enrollment (Actual): 1795

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

Inclusion criteria

• Patients diagnosed with metastatic melanoma (C43) during 01 January 2014 and 31 December 2021.
• Adult (18 years or older) at the time of diagnosis of metastatic melanoma.
• Resident in the corresponding hospital district(s) at the time of diagnosis of metastatic melanoma.

Exclusion criteria

• Metastasis recorded prior to 01 January 2014 (i.e. prevalent case).
• Record of any other cancer (The International Classification of Diseases, 10th Revision [ICD-10] diagnosis code starting with C, excluding C43, C77, C78, and C79) as last cancer diagnosis before metastasis.
• Participated in COBRA (vemurafenib, temozolomide, lomustine, vincristine) trial.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Distant Metastasis Cohort; Adult patients diagnosed with stage 4 (distant) metastatic melanoma between 2014 and 2021.
Regional Metastasis Cohort; Adult patients diagnosed with stage 3 (regional) metastatic melanoma between 2014 and 2021.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021		Up to approximately 7 years
Point Prevalence per 100,000 Population	Point prevalence was defined as the number of metastatic melanoma patients alive at the end of 2021 divided by the total of hospital districts of Helsinki and Uusimaa hospital district (HUS), Pirkanmaa hospital district (PSHP), and Hospital district of Southwest Finland (VSSHP).	Up to approximately 7 years
Mean Age of Patients at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Mean Length of Follow-up at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Gender at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients with Negative BRAF Status at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District	CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2).	Index date, defined as date of metastasis diagnosis
Number of Patients by Number of Metastatic Organs at Index Date per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients by Location of Metastases at Index Date per Hospital District	Locations of metastatic sites at study entry: lymph node; lung; skin/subcutaneous; liver; brain; bone; kidney; peritoneum/peritoneal cavity; spleen; pancreas; intestine	Index date, defined as date of metastasis diagnosis
Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District		Index date, defined as date of metastasis diagnosis
Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication		5 years prior to index date, where index date was defined as date of metastasis diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival was defined as the time from the index date until death or to end of study follow-up. Index date was defined as date of metastasis diagnosis.	Up to approximately 7 years
Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment	TTNT was defined as the time from initiation of a treatment line until the initiation of the next treatment line, death, or end of study follow-up.	Up to approximately 7 years
Duration of Treatment (DoT)	DoT was defined as the time from initiation of a treatment line until the end of treatment, death, or end of study follow-up.	Up to approximately 7 years
Mean Age at Index Date per First-line (1L) Medication		Index date, defined as date of metastasis diagnosis
Length of Follow-up at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Time to Treatment at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Gender at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients with Negative BRAF Status at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication	CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2).	Index date, defined as date of metastasis diagnosis
Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients by Location of Metastases at Index Date per 1L Medication	Locations of metastatic sites at study entry: lymph node; lung; skin/subcutaneous; liver; brain; bone; kidney; peritoneum/peritoneal cavity; spleen; pancreas; intestine	Index date, defined as date of metastasis diagnosis
Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication		Index date, defined as date of metastasis diagnosis
Number of Patients that Received Radiotherapy During 1L Treatment		Index date, defined as date of metastasis diagnosis
Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment		Up to approximately 7 years
Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment		Up to approximately 7 years
Number of Patients Switched from TT 1L Treatment to IO 2L Treatment		Up to approximately 7 years
Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment		Up to approximately 7 years
Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment		Up to approximately 7 years
Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment		Up to approximately 7 years
Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment		Up to approximately 7 years
Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment		Up to approximately 7 years
Number of Patients Switched from TT 2L Treatment to IO 3L Treatment		Up to approximately 7 years
Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment		Up to approximately 7 years
Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment		Up to approximately 7 years
Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment		Up to approximately 7 years
Number of Healthcare Contacts and Associated Costs per Patient Year	Costs of outpatient visits, hospitalizations, and emergency room (ER) visits were estimated using unit costs and thus contain an average cost of performed procedures and operations, analyzed laboratory tests, and given medications (i.e. hospital inpatient medications) during the healthcare contact.	Up to approximately 7 years
Number of Healthcare Contacts and Associated Costs per Patient	Costs of outpatient visits, hospitalizations, and emergency room (ER) visits were estimated using unit costs and thus contain an average cost of performed procedures and operations, analyzed laboratory tests, and given medications (i.e. hospital inpatient medications) during the healthcare contact.	Up to approximately 7 years
Number of Healthcare Contacts and Associated Total Costs	Costs of outpatient visits, hospitalizations, and emergency room (ER) visits were estimated using unit costs and thus contain an average cost of performed procedures and operations, analyzed laboratory tests, and given medications (i.e. hospital inpatient medications) during the healthcare contact.	Up to approximately 7 years

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: CDRB436BFI02