This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record.
Study Type
OBSERVATIONAL
Enrollment
90
Novartis
Shanghai, China
Real-world overall response rate (rwORR)
ORR was defined as the percentage of patients demonstrating a best overall response as complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or as documented per physician assessment, as available.
Time frame: Up to approximately 2.6 years
Mean Age
Time frame: Baseline
Percentage of patients per sex
Time frame: Baseline
Number of years of disease history at treatment initiation since initial melanoma diagnosis
Time frame: Baseline
Number and percentage of patients per anatomic sites of origin
Time frame: Baseline
Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis
Time frame: Baseline
Number and percentage of patients per tumor stage
Time frame: Baseline
Number and percentage of patients with occurrence of tumor metastasis
Time frame: Baseline
Number and percentage of patients per metastatic location
Time frame: Baseline
Number and percentage of patients per metastases
Time frame: Baseline
Lactate dehydrogenase (LDH) levels
Time frame: Baseline
Eastern Cooperative Oncology Group (ECOG) performance status
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Time frame: Baseline
Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment
Time frame: Baseline
Number and percentage of patients per type of surgery
Time frame: Baseline
Number and percentage of patients per name of surgery
Time frame: Baseline
Number and percentage of patients per surgical and medical procedure
Time frame: Baseline
Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment
Time frame: Baseline
Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent
Time frame: Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting
Time frame: Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment
Time frame: Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type
Time frame: Baseline
Number and percentage of patients per reason for immunotherapy discontinuation
Time frame: Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response
Time frame: Baseline
Number and percentage of patients per prior anti-neoplastic drug for melanoma
Time frame: Baseline
Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment
Time frame: Baseline
Number and percentage of patients with prior radiotherapy for melanoma per treatment intent
Time frame: Baseline
Number and percentage of patients with prior radiotherapy for melanoma per treatment setting
Time frame: Baseline
Number and percentage of patients per radiation site
Time frame: Baseline
Mean total dosage for all radiotherapy
Time frame: Baseline
Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response
Time frame: Baseline
Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment
Time frame: Up to approximately 2.2 years
Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent
Time frame: Up to approximately 2.2 years
Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting
Time frame: Up to approximately 2.2 years
Number and percentage of patients per type of D+T treatment change
Time frame: Up to approximately 2.2 years
Number and percentage of patients per reason for D+T treatment change
Time frame: Up to approximately 2.2 years
Mean duration of D+T, if not ongoing to end of study follow-up
Time frame: Up to approximately 2.2 years
rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS)
Time frame: Up to approximately 2.6 years
Real-world disease control rate (rwDCR) of D+T (FAS)
rwDCR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or non-CR or non-progressive disease (non-PD), per RECIST version 1.1 or as documented per physician assessment, as available.
Time frame: Up to approximately 2.6 years
Real-world duration of response (rwDOR) of dabrafenib plus trametinib
For the subset of patients with CR or PR, rwDORn was defined as the time from the date of the first documented CR or PR per RECIST version 1.1 or as documented per physician assessment as available, to the first disease progression or death due to any cause.
Time frame: Up to approximately 2.6 years
Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS)
rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Time frame: Up to approximately 2.6 years
Real-world overall survival (rwOS) since D+T initiation (FAS)
rwOS was defined as the time from start of treatment to death due to any cause.
Time frame: Up to approximately 2.6 years
Time to treatment discontinuation (FAS)
Time frame: Up to approximately 2.6 years
Number and percentage of patients with adverse events of special interest (AESIs) (FAS)
AESIs were defined based on the case retrieval strategy file available at the time of analysis.
Time frame: Up to approximately 2.6 years
Number and percentage of patients with serious adverse events (SAEs) (FAS)
Time frame: Up to approximately 2.6 years
rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use
rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Time frame: Up to approximately 2.6 years
rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use
rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Time frame: Up to approximately 2.6 years
rwOS since D+T initiation (MMS), by immunotherapy use
rwOS was defined as the time from start of treatment to death due to any cause.
Time frame: Up to approximately 2.6 years
rwOS since D+T initiation (NMS), by immunotherapy use
rwOS was defined as the time from start of treatment to death due to any cause.
Time frame: Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T
Time frame: Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment
Time frame: Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up
Time frame: Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type
Time frame: Up to approximately 2.6 years
Number and percentage of patients per reason for immunotherapy discontinuation
Time frame: Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response
Time frame: Up to approximately 2.6 years
Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment
Time frame: Up to approximately 2.6 years
Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication
Time frame: Up to approximately 2.6 years
Number and percentage of patients per concomitant medication
Time frame: Up to approximately 2.2 years
Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS)
Time frame: Up to approximately 2.6 years
Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use
Time frame: Up to approximately 2.6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.