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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-adjuvant Dab+Tram Cohort | Adult melanoma patients who were prescribed non-adjuvant Dab+Tram. | ||
| Adjuvant Dab+Tram Cohort | Adult melanoma patients who were prescribed adjuvant Dab+Tram. | ||
| Enco+Bini Cohort | Adult melanoma patients who were prescribed Enco+Bini. | ||
| Overall Cohort | Adult melanoma patients who were prescribed Dab+Tram or Enco+Bini between 01 January 2012 and 30 June 2021. |
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| Measure | Description | Time Frame |
|---|---|---|
| Age at Date of Treatment Initiation | Age at date of treatment initiation (index date B) stratified by LoT. | Throughout the study identification period, approximately 9 years, 6 months |
| Number of Patients by Clinical Characteristics at the Date of Treatment Initiation | Clinical characteristics at the date of treatment initiation (index date B) stratified by LoT. Clinical Characteristics included:
| Throughout the study identification period, approximately 9 years, 6 months |
| Weight at Date of Treatment Initiation | Weight at the date of treatment initiation (index date B) stratified by LoT. | Throughout the study identification period, approximately 9 years, 6 months |
| Height at Date of Treatment Initiation | Height at the date of treatment initiation (index date B) stratified by LoT. | Throughout the study identification period, approximately 9 years, 6 months |
| BMI at Date of Treatment Initiation | BMI at the date of treatment initiation (index date B) stratified by LoT. | Throughout the study identification period, approximately 9 years, 6 months |
| CCI Score at Date of Treatment Initiation | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Age at Date of Melanoma Diagnosis | Age at the date of melanoma diagnosis (index date A). | Throughout the study identification period, approximately 9 years, 6 months |
| Number of Patients by Gender at Date of Melanoma Diagnosis |
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Inclusion criteria:
All patients who met all of the following criteria were included:
The Adjuvant Dab+Tram Cohort included all patients who met all of the following criteria:
The Non-adjuvant Dab+Tram Cohort included all patients that met all of the following criteria:
The Cohort Enco+Bini included all patients that met all of the following criteria:
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:
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Adult melanoma patients prescribed dabrafenib and trametinib or encorafenib and binimetinib between 01 January 2012 and 30 June 2021 in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharma K.K. | Tokyo | 105-6333 | Japan |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| Throughout the study identification period, approximately 9 years, 6 months |
| Time From Diagnosis to First Targeted Therapy Initiation | Time from diagnosis to treatment initiation stratified by LoT. | Throughout the study identification period, approximately 9 years, 6 months |
| Time From Diagnosis to First Surgery | Time from diagnosis to first surgery stratified by LoT. | Throughout the study identification period, approximately 9 years, 6 months |
Gender at the date of melanoma diagnosis (index date A).
| Throughout the study identification period, approximately 9 years, 6 months |
| Number of Patients by Clinical Characteristics at the Date of Melanoma Diagnosis | Clinical characteristics at the date of melanoma diagnosis (index date A). Clinical Characteristics included:
| Throughout the study identification period, approximately 9 years, 6 months |
| Weight at Date of Melanoma Diagnosis | Weight at the date of melanoma diagnosis (index date A). | Throughout the study identification period, approximately 9 years, 6 months |
| Height at Date of Melanoma Diagnosis | Height at the date of melanoma diagnosis (index date A). | Throughout the study identification period, approximately 9 years, 6 months |
| BMI at Date of Melanoma Diagnosis | BMI at the date of melanoma diagnosis (index date A). | Throughout the study identification period, approximately 9 years, 6 months |
| CCI Score at Date of Melanoma Diagnosis | 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). | Throughout the study identification period, approximately 9 years, 6 months |
| Number of Patients by Hospital Size at Date of Melanoma Diagnosis | Number of patients by hospital size at the date of melanoma diagnosis (index date A). | Throughout the study identification period, approximately 9 years, 6 months |
| 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 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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