В данном разделе указаны критерии оценки клинической значимости применения дорогостоящей противоопухолевой лекарственной терапии в соответствии со шкалой, разработанной экспертной группой (см. стр. 7). В тексте они обозначены, как магнитуда клинической значимости (МКЗ).

В данном разделе указаны критерии оценки клинической значимости применения дорогостоящей противоопухолевой лекарственной терапии в соответствии со шкалой, разработанной экспертной группой (см. стр. 7). В тексте они обозначены, как магнитуда клинической значимости (МКЗ).

Cutaneous melanoma (CM) — an extremely malignant tumor that needs to be diagnosed at the earliest stages. Dermoscopy is a highly effective method for early diagnosis of CM. This non-invasive method of skin epiluminescene microscopy using an optical device — dermoscope, provides images of the surface and internal structures of the skin. Knowledge of the dermoscopycal signs and algorithms helps to identify the CM among the other pigmented skin pathology. Application of dermoscope reduces the risk of unnecessary surgical procedures in the diagnosis of pigmented lesions of the skin. Considering the importance of early diagnosis of CM we developed a unique screening program, which was attended by a total of five oncologists. After a preliminary analysis of the on-line profiles with photos of pigmented lesions of the skin, experts internally examined only those patients, whose photographs of skin lesions were suspicious for CM. Dermoscopy was actively used during medical examination. As a result, the screening program has identified the patients with early stages of CM (IA—IIA). Thus dermoscopy is useful and necessary tool for early detection of MK, including the screening programs.

The expression of genes for 15 cancer-testis antigens and 4 melanoma differentiation antigens in 21 metastatic melanoma cell lines using a RT-PCR assay was analysed. The morphological examination allowed us to divide all analyzed cell lines into three groups with a high, intermediate, and low level of differentiation of tumour cells. Correlation analysis of gene expression and cell morphology demonstrated interrelation between increased expression of cancer-testis genes and differentiation grade of cancer cells. Data obtained can be used for the disease prognosis and promote optimization of medical treatment.

Immunotherapy of tumor is considered to be a promising approach for cancer treatment. The precise methods of immune response efficacy assessment are not fully characterized. We have conducted phase I single center open study to assess applicability of ELISpot method for immune response assessment in 15 melanoma patients treated with dendritic cells-based anticancer vaccine. Immune response was detected in 33 % (5) of patients. Here we show that the activation of immune response did not correlate to clinical response but to delayed hypersensitivity reaction development. Our observations indicate that ELISpot-detected immune response was more common in patients who had initially low S-100 marker level.

The study assessed response of immune system of patients with recurrent skin melanoma to vaccination by antitumor vaccine Allogen in phase I clinical trial. Vaccine 'Allogen is prepared from irradiated melanoma cells Mel-Pol [1] that were transitorily transfected by gene Tag-7. Patients' blood lymphocyte subpopulation contents was determined by the panel of monoclonal antibodies against lymphocyte differentiation antigens before the initial vaccination and prior to every following vaccination. CD3, CD4, CD8, CD5, CD7, CD11b, CD16, CD25, CD38, CD71, CD95, CD56 antigen expression was analyzed. CD38/CD4, CD38/CD8, CD16b/CD16, CD11b/CD8, CD11b/CD56 antigen expression was assessed by double staining technique. The results showed that vaccination led to increased percentage of positive cells with activation antigens CD25, CD71, CD38, CD95.

The effectiveness of traditional chemotherapy (with temozolomide, fotemustine, lomustine) alone or in combination with whole brain radiotherapy in melanoma patients with cerebral metastases does not exceed 7–10  % with no significant impact on survival, which is around 2–4  months. Targeted therapy helped to improve survival of patients with disseminated melanoma and BRAF V600 mutations. The use of targeted drugs in patients with brain metastases allows to control the tumor process and to succeed in treatment of cerebral metastases. According to currently available research data and our own results, the effectiveness of targeted therapy with vemurafenib in melanoma patients positive for BRAF V600 mutations with brain metastases reaches 18.0–44.5  % with median survival of 5.3–8.0  months. Evidences suggest that the use of vemurafenib in melanoma patients with brain metastases ensure effective disease control in most of the cases and has a significant advantage comparing to conventional chemotherapy and whole brain radiotherapy. According to the results of these studies vemurafenib can be recommended as a 1st line targeted drug for treatment of melanoma patients with BRAF V600 mutations and brain metastases. Despite the existence of blood-brain barrier and efflux systems, new targeted drugs showed promising results in treatment of brain metastases. Over the last few years we have enhanced our understanding of brain metastasis mechanisms, principles of blood-brain barrier functioning, and  ways  of  cancer  drugs penetration into  the  central  nervous system.  Targeted  therapy  is  constantly developing and  will play an increasing role in treatment of melanoma cerebral metastases in the future with finding of new targets.