A real-world study of dabrafenib combined with trametinib in the treatment of unresectable or metastatic mucosal malignant melanoma with BRAF-V600E mutations

A real-world study of dabrafenib combined with trametinib in the treatment of unresectable or metastatic mucosal malignant melanoma with BRAF-V600E mutations

The Mucosal melanoma is a rare type of skin cancer with unique features. About 12.5% of patients have a BRAF gene mutation. These patients tend to get the disease at a younger age, have a poorer outlook, and are more likely to have ulcers in the tumor. Targeted drugs for this mutation (BRAF inhibitors combined with MEK inhibitors) did not include mucosal melanoma patients in their initial studies. This type of melanoma is more common in Asian populations. However, there is still a lack of data on how well targeted therapies work for these patients. So, we urgently need effective, evidence-based treatments.This study is a real-world data analysis. Its main goal is to evaluate how well the combination of dabrafenib and trametinib works as a first treatment for patients with unresectable or metastatic BRAF V600-mutant mucosal melanoma, and how safe it is.The study will also have a control group. The control group will be made up of patients with BRAF V600-mutant non-mucosal melanoma who are treated with the same targeted drugs. Their data also come from real-world settings.The study plans to include patients with advanced mucosal and non-mucosal melanoma who started treatment with dabrafenib plus trametinib between May 1, 2020, and July 3, 2025.The main measure is the overall response rate - the percentage of patients whose tumors shrink significantly after treatment. Secondary measures include the disease control rate (percentage whose disease is controlled), progression-free survival (how long patients live without their disease getting worse), overall survival (how long patients live overall), and any side effects (including serious ones) that occur during treatment.This research aims to provide valuable real-world evidence for Chinese patients with BRAF-mutant mucosal melanoma.