A Non-interventional and Retrospective Study Describing the Patient Profile and Treatment Patterns in Real-world Melanoma Patients Prescribed With Dab+Tram or Enco+Bini in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Age at Date of Treatment Initiation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
结局指标
主要结局
Age at Date of Treatment Initiation
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Throughout the study identification period, approximately 9 years, 6 months
Time from diagnosis to first surgery stratified by LoT.
次要结局
- Age at Date of Melanoma Diagnosis(Throughout the study identification period, approximately 9 years, 6 months)
- Number of Patients by Gender at Date of Melanoma Diagnosis(Throughout the study identification period, approximately 9 years, 6 months)
- Number of Patients by Clinical Characteristics at the Date of Melanoma Diagnosis(Throughout the study identification period, approximately 9 years, 6 months)
- Weight at Date of Melanoma Diagnosis(Throughout the study identification period, approximately 9 years, 6 months)
- Height at Date of Melanoma Diagnosis(Throughout the study identification period, approximately 9 years, 6 months)
- BMI at Date of Melanoma Diagnosis(Throughout the study identification period, approximately 9 years, 6 months)
- CCI Score at Date of Melanoma Diagnosis(Throughout the study identification period, approximately 9 years, 6 months)
- Number of Patients by Hospital Size at Date of Melanoma Diagnosis(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)