Introduction/Objective The purpose of this study was to assess the effectiveness of different approaches
in the treatment of metastatic melanoma in daily clinical practice in a situation with limited and late
availability of new drugs in a resource-limited country and to compare these parameters with those
reported in clinical studies and from other real-world data.
Methods Main methods included assessment of overall survival (OS) and progression-free survival (PFS).
Patients were included in the study if they were treated with first or second-line systemic therapy for radiologically/pathologically confirmed metastatic melanoma. Patients were divided into four groups based on
the type of therapy they received: chemotherapy (dacarbazin), BRAF inhibitor (vemurafenib), BRAF/MEK
inhibitors (vemurafenib/cobimetinib and trametinib/dabrafenib) and anti PD-1 therapy with pembrolizumab.
Results Regardless of the line of therapy, the calculated median OS in chemotherapy and vemurafenib
group was nine months. The median OS in the BRAF/MEK inhibitor group was 14 months and 15 months
in the pembrolizumab group. Median PFS in the chemotherapy group was four months, seven months
for vemurafenib, in the BRAF/MEK inhibitor group nine months and in the pembrolizumab group six
months. There was a statistically significant difference in survival between first and second-line therapy
in the pembrolizumab group.
Conclusion Our results showed lower median OS and PFS in comparison to reported data from clinical
trials. Compared to other real-world data from countries with similar problems related to the late reimbursement of new drugs, our research has shown similar results.
