Metastatic Melanoma
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Novartis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 | Up to approximately 7 years | — |
| Point Prevalence per 100,000 Population | Up to approximately 7 years | 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). |
| 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 | Index date, defined as date of metastasis diagnosis | 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). |
| 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 | Index date, defined as date of metastasis diagnosis | Locations of metastatic sites at study entry: * lymph node * lung * skin/subcutaneous * liver * brain * bone * kidney * peritoneum/peritoneal cavity * spleen * pancreas * intestine |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Overall Survival (OS) | Up to approximately 7 years | 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. |
| Number of Healthcare Contacts and Associated Costs per Patient Year | Up to approximately 7 years | 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. |
| Number of Healthcare Contacts and Associated Costs per Patient | Up to approximately 7 years | 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. |
| Number of Healthcare Contacts and Associated Total Costs | Up to approximately 7 years | 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. |
| Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment | Up to approximately 7 years | — |
| Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment | Up to approximately 7 years | 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. |
| Duration of Treatment (DoT) | Up to approximately 7 years | DoT was defined as the time from initiation of a treatment line until the end of treatment, death, or end of study follow-up. |
| 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 | Index date, defined as date of metastasis diagnosis | 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). |
| 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 | Index date, defined as date of metastasis diagnosis | Locations of metastatic sites at study entry: * lymph node * lung * skin/subcutaneous * liver * brain * bone * kidney * peritoneum/peritoneal cavity * spleen * pancreas * intestine |
Countries
Switzerland
Outcome results
None listed