The primary objective for this non-interventional study is to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L questionnaire.The secondary study objectives are to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that start adjuvant treatment with dabrafenib and trametinib. In addition, this study aims to explore if treatment discontinuation affects clinical outcomes in real-world practice.
Name: dabrafenib + trametinib
Description: Health-related quality of life in melanoma patients defined as the mean difference in FACT-M (Functional Assessment of Cancer Therapy - Melanoma ) score. FACT-M is a specific version of FACT questionnaire validated for patients with any stage of melanoma and includes items related to physical, functional, social and emotional well-being, and specific concerns of melanoma patients and melanoma patients undergoing surgery. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172. Higher scores represent a better quality of life.
Measure: Change from baseline in FACT-M score Time: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16Description: Health-related quality of life in melanoma patients defined as the mean difference in EQ-5D-3L score. EQ-5D-3L is a descriptive questionnaire comprising five dimensions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels of severity: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions.
Measure: Change from baseline in EQ-5D-3L score Time: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16Description: Total duration of treatment defined as median time on adjuvant treatment (from start to end of treatment/permanent treatment discontinuation).
Measure: Total duration of treatment Time: months 12Description: Proportion of patients on treatment in each visit
Measure: Proportion of patients on treatment in each visit Time: Baseline, months 3-4, months 6-8, months 9-12, month 12Description: Rate of permanent study drug discontinuation due to any reason.
Measure: Rate of permanent study drug discontinuation due to any reason Time: month 12Description: Rate of permanent drug discontinuation due to pirexia over the course of adjuvant treatment.
Measure: Rate of permanent drug discontinuation due to pirexia Time: month 12Description: Rate of permanent drug discontinuation due to AEs over the course of adjuvant treatment
Measure: Rate of permanent drug discontinuation due to AEs Time: month 12Description: Reason of treatment discontinuation (death, relapse, AEs, significant change in FACT-M, significant change in EQ-5D-3L , withdrawal of consent, other).
Measure: Reason of treatment discontinuation Time: month 12Description: Average dose of dabrafenib and trametinib used during the treatment, including dose reductions.
Measure: Average dose of dabrafenib and trametinib used during the treatment Time: month 12Description: Percentage of patients with dose reduction during treatment, and in this case, reason for dose reduction
Measure: Proportion of patients who had dose reduction Time: month 12Description: RFS (Relapse Free Survival)
Measure: Relapse Free Survival rate Time: month 12Description: DMFS (distant-metastasis-free survival) rate
Measure: distant-metastasis-free survival rate Time: month 12Description: OS (Overall Survival) rate
Measure: Overall Survival rate Time: month 12Cohort
There is one SNP
Inclusion Criteria: - Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study - V600E/K mutation-positive cutaneous melanoma - Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) as indicated in the SmPC and by prescription, that has been started before inclusion of the patient into the study; - ≥ 18 years of age - Written informed consent signed. --- V600E ---