Experience of the use of combination of dabrafenib and trametinib in patients with metastatic skin melanoma in real clinical practice in Russia

Over the past 5 years, the treatment of metastatic and irresectable melanoma has undergone significant changes. Large clinical trials have shown high efficacy of new drugs. The experience of using a combination of dabrafenib and trametinib in the framework of the Program of expanded access to these drugs in Russia was analyzed. In the period from March 2015 to June 2015, the program included 14 patients. The median age was 45 years (range - 30-63), 38.5% male; BRAF V600Emutation was detected in the tumor in all patients. 84.6% of patients had ECOG performance status score of 0-1, M1c stage of disease was determined in 76.9% of patients. The elevated lactate dehydrogenase levels were detected in 46.2% of patients. 53.8% of patients received two or more lines of the previous therapy. The frequency of objective responses to treatment was 61.5%, stabilization - 15.4%, progression - 23.1%. The median progression-free survival was 7.29 months (95% CI 3.74-10.84), a 2-year progression-free survival rate - 22%. The median overall survival was 13.27 months (95% CI - 10.3-16.2 months), a two-year overall survival rate - 43%. During the study, there were no serious adverse events associated with medications. Also, there were no new adverse events. It was concluded that the combination of BRAF inhibitor and MEK inhibitor - dabrafenib and trametinib - is a highly effective and well tolerated treatment for metastatic or unresectable melanoma with a BRAF V600 mutation in the first and subsequent lines of therapy. The data of the above mentioned expanded access program are consistent with the results of previous randomized trials.

metastatic melanoma, BRAF inhibitors, MEK inhibitors, dabrafenib, trametinib