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.
Doxorubicin (DOX) is one of the drugs necessary for the treatment of the 10 most common types of cancer. The leading adverse effect limiting clinical use of DOX is cardiotoxicity. Given that literature data indicate a protective role of carotenoids in doxorubicin-induced toxicity, in our study we compared the cardioprotective effect of a mixture of pumpkin carotenoids and a commercially available antioxidant preparation. Animals were distributed in 8 groups (Control -S; NADES -N; Doxorubicin -Dox; Carotenoids -Car; CardiofortIN -CF; NADES-Doxorubicin -N-Dox; Carotenoids-Doxorubicin -Car-Dox; CardiofortIN-Doxorubicin -CF-Dox). Histological sections were stained with the hematoxylin-eosin (HE) and analyzed for the presence of myocardial damage by doxorubicin damage score (DDS). From the heart tissue homogenate were determined the intensity of lipid peroxidation and specific antioxidative enzyme activity (superoxide dismutase; catalase; glutathione S-transferase; glutathione peroxidase). In Car-DOX and CF-DOX groups, lipid peroxidation is significantly reduced compared to DOX group. Pretreatment of animals with carotenoids and in lesser extent with CardiofortIN led to higher antioxidative enzymes activity, compared to DOX group. Pretreated with carotenoids, only 50 % of animals had some degree of myocardial damage, and no animals had extensive damage. CardiofortIN pretreatment showed less protective effect. Pretreatment with carotenoid extract, reduced DDS significantly, so Car-DOX group has changes equivalent to mild myocardial damage. Although CardiofortIN pretreatment lowered DDS score values, animals still had moderate level of myocardium damage. This in vivo study and its findings indicate that carotenoids extracted from pumpkin may be a promising cardioprotective agent against doxorubicin induced cardiotoxicity, at least in part mediated through inhibition of DOX-induced oxidative stress.
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