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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion criteria
Exclusion criteria
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This was a retrospective, noninterventional cohort study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Basel | 4056 | Switzerland |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 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:
| 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 |
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:
| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |