Melanoma
Conditions
Keywords
Melanoma, Dab+Tram, Enco+Bini, Patient profile, Treatment patterns
Brief summary
The aim of this study was to describe the patient profile and treatment patterns of adult melanoma patients that were treated with either dabrafenib and trametinib (Dab+Tram) or encorafenib and binimetinib (Enco+Bini) between 01 January 2012 and 30 November 2021 in Japan.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients who met all of the following criteria were included: * Had a confirmed diagnosis of melanoma recorded during the identification period, and * Had at least 6 months of enrollment before the index date A, where index date A was defined as the first date of a confirmed diagnosis of melanoma recorded during the identification period, and * Were at least 18 years old at the time of initiation of the first line of treatment (LoT). The Adjuvant Dab+Tram Cohort included all patients who met all of the following criteria: * Satisfied all of the general inclusion criteria, and * Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and * Had at least 6 months of follow-up after the index date B, where index B was defined as the first date of a prescription recorded at or after index date A, and * Had the first dabrafenib or trametinib prescription claim recorded within 12 weeks of an excision surgery, and * Did not have a confirmed metastasis diagnosis recorded within 1 month before, at, or within 12 weeks after the index date A. The Non-adjuvant Dab+Tram Cohort included all patients that met all of the following criteria: * Satisfied all of the general inclusion criteria, and * Had a dabrafenib prescription claim and a trametinib prescription claim recorded after or at the index date A, and * Had at least 6 months of follow-up after the index date B, and * Not included in the Adjuvant Dab+Tram Cohort. The Cohort Enco+Bini included all patients that met all of the following criteria: * Satisfied all of the general inclusion criteria, and * Had an encorafenib prescription claim and a binimetinib prescription claim recorded after or at the index date A, and * Had at least 6 months of follow-up after the index date B. The Overall Cohort included all patients that met all of the following criteria: • Included in either the Adjuvant Dab+Tram Cohort, the Non-adjuvant Dab+Tram Cohort, or the Enco+Bini Cohort. A patient could be considered in multiple cohorts and was considered once only in analysis of the Overall Cohort.
Exclusion criteria
* Had a prescription claim with a melanoma treatment recorded within 6 months before the index date A, or * Had a confirmed diagnosis of a non-small cell lung cancer recorded any time before the index date A for the Adjuvant Dab+Tram Cohort and the Non-adjuvant Dab+Tram Cohort, or * Had a confirmed diagnosis of a colorectal cancer recorded any time before the index date A for the Enco+Bini Cohort.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Age at Date of Treatment Initiation | Throughout the study identification period, approximately 9 years, 6 months | Age at date of treatment initiation (index date B) stratified by LoT. |
| Number of Patients by Clinical Characteristics at the Date of Treatment Initiation | Throughout the study identification period, approximately 9 years, 6 months | Clinical characteristics at the date of treatment initiation (index date B) stratified by LoT. Clinical Characteristics included: * Index calendar year * Age group * Body mass index (BMI) category * Charlson comorbidity index (CCI) category * Tumor, Node, Metastases (TNM) stage * Type of surgery before treatment initiation |
| Weight at Date of Treatment Initiation | Throughout the study identification period, approximately 9 years, 6 months | Weight at the date of treatment initiation (index date B) stratified by LoT. |
| Height at Date of Treatment Initiation | Throughout the study identification period, approximately 9 years, 6 months | Height at the date of treatment initiation (index date B) stratified by LoT. |
| BMI at Date of Treatment Initiation | Throughout the study identification period, approximately 9 years, 6 months | BMI at the date of treatment initiation (index date B) stratified by LoT. |
| CCI Score at Date of Treatment Initiation | Throughout the study identification period, approximately 9 years, 6 months | CCI score at the date of treatment initiation (index date B) stratified by LoT. CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2). |
| Time From Diagnosis to First Targeted Therapy Initiation | Throughout the study identification period, approximately 9 years, 6 months | Time from diagnosis to treatment initiation stratified by LoT. |
| Time From Diagnosis to First Surgery | Throughout the study identification period, approximately 9 years, 6 months | Time from diagnosis to first surgery stratified by LoT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age at Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | Age at the date of melanoma diagnosis (index date A). |
| Number of Patients by Gender at Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | Gender at the date of melanoma diagnosis (index date A). |
| Number of Patients by Clinical Characteristics at the Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | Clinical characteristics at the date of melanoma diagnosis (index date A). Clinical Characteristics included: * Index calendar year * Age group * BMI category * CCI category * TNM stage |
| Weight at Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | Weight at the date of melanoma diagnosis (index date A). |
| Height at Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | Height at the date of melanoma diagnosis (index date A). |
| BMI at Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | BMI at the date of melanoma diagnosis (index date A). |
| CCI Score at Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | CCI score at the date of melanoma diagnosis (index date A). CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2). |
| Number of Patients by Hospital Size at Date of Melanoma Diagnosis | Throughout the study identification period, approximately 9 years, 6 months | Number of patients by hospital size at the date of melanoma diagnosis (index date A). |
| Proportion of Patients by Most Common Treatment Regimens (Top 5) in Each LoT | Up to approximately 10 years, 5 months | — |
| Among Patients who Initiatied Dab+Tram at the First LoT, Proportion of Patients Switching to Either Another Targeted Therapy or Immunotherapy | Up to approximately 10 years, 5 months | — |
| Among Patients who Initiatied Enco+Bini at the First LoT, Proportion of Patients Switching to Either Another Targeted Therapy or Immunotherapy | Up to approximately 10 years, 5 months | — |
| Proportion of Patients who Discontinued Treatment | Up to approximately 10 years, 5 months | — |
Countries
Japan
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed