The primary objective for this non-interventional study was 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 were to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that started adjuvant treatment with dabrafenib and trametinib. In addition, this study aimed to explore if treatment discontinuation affects clinical outcomes in real-world practice.
The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting was planned to be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience. Patients were recruited from participating centers in the routine setting. This was done only if the decision about starting treatment with dabrafenib and trametinib had already been made. All patients that complied with the inclusion criteria and that started treatment with dabrafenib+ trametinib during the recruitment period were considered to participate in the study, at investigator discretion. Health related quality of life had to be assessed by FACT-M and EQ-5D-3L questionnaires after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion.
Study Type
OBSERVATIONAL
Enrollment
3
There was no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that had started before inclusion of the patient into the study could be enrolled.
Novartis Investigative Site
Coimbra, Center, Portugal
Novartis Investigative Site
Porto, North, Portugal
Change from baseline in FACT-M score
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.
Time frame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
Change from baseline in EQ-5D-3L score
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 was asked to indicate his/her health state by checking the box next to the most appropriate response level of each of the five dimensions.
Time frame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16
Total duration of treatment
Total duration of treatment defined as median time on adjuvant treatment (from start to end of treatment/permanent treatment discontinuation).
Time frame: months 12
Proportion of patients on treatment in each visit
Proportion of patients on treatment in each visit
Time frame: Baseline, months 3-4, months 6-8, months 9-12, month 12
Rate of permanent study drug discontinuation due to any reason
Rate of permanent study drug discontinuation due to any reason.
Time frame: month 12
Rate of permanent drug discontinuation due to pirexia
Rate of permanent drug discontinuation due to pirexia over the course of adjuvant treatment.
Time frame: month 12
Rate of permanent drug discontinuation due to AEs
Rate of permanent drug discontinuation due to AEs over the course of adjuvant treatment
Time frame: month 12
Reason of treatment discontinuation
Reason of treatment discontinuation (death, relapse, AEs, significant change in FACT-M, significant change in EQ-5D-3L , withdrawal of consent, other).
Time frame: month 12
Average dose of dabrafenib and trametinib used during the treatment
Average dose of dabrafenib and trametinib used during the treatment, including dose reductions.
Time frame: month 12
Proportion of patients who had dose reduction
Percentage of patients with dose reduction during treatment, and in this case, reason for dose reduction
Time frame: month 12
Relapse Free Survival rate
RFS (Relapse Free Survival)
Time frame: month 12
distant-metastasis-free survival rate
DMFS (distant-metastasis-free survival) rate
Time frame: month 12
Overall Survival rate
OS (Overall Survival) rate
Time frame: month 12
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