Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients
- Conditions
- Metastatic Melanoma
- Registration Number
- NCT06369428
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1795
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 Up to approximately 7 years Gender at Index Date per Hospital District Index date, defined as date of metastasis diagnosis 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 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 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 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
* intestineNumber 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 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 Negative BRAF Status 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 by Number of Metastatic Organs at Index Date per Hospital District 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
- Secondary Outcome Measures
Name Time Method Time to Treatment 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 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.
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.
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.
Length of Follow-up at Index Date per 1L Medication Index date, defined as date of metastasis diagnosis Mean Age at Index Date per First-line (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 Negative BRAF Status at Index Date per 1L Medication 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 TT 1L Treatment to IO 2L Treatment Up to approximately 7 years Number of Patients Switched from TT 2L Treatment to IO 3L Treatment Up to approximately 7 years Gender at Index Date per 1L Medication 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 Switched from TT 1L Treatment to Chemo 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 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 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 Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication Index date, defined as date of metastasis diagnosis 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 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 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
* intestineNumber of Patients that Received Radiotherapy During 1L Treatment Index date, defined as date of metastasis diagnosis Number of Patients Switched from IO 1L Treatment to Chemotherapy (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 IO 2L Treatment to Chemo 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 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.
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland