LONG-TERM OUTCOMES OF SENTINEL LYMPH NODE BIOPSY VERSUS LYMPH NODE OBSERVATION IN MELANOMA PATIENTS. / ВІДДАЛЕНІ РЕЗУЛЬТАТИ БІОПСІЇ СТОРОЖОВОГО ЛІМФАТИЧНОГО ВУЗЛА В ПОРІВНЯННІ ЗІ СПОСТЕРЕЖЕННЯМ ЗА ЛІМФАТИЧНИМИ ВУЗЛАМИ У ПАЦІЄНТІВ З МЕЛАНОМОЮ.

OBJECTIVE: evaluating the influence of sentinel lymph node biopsy without following completion lymph node dissection independent on sentinel lymph node status on the outcome in patients with skin melanoma. MATERIALS AND METHODS: Three hundred nine patients with a primary skin melanoma were randomly assigned to wide excision of the primary tumor and sentinel lymph node biopsy without following completion lymph-node dissection independent on sentinel lymph node status or to wide excision of skin melanoma. Low-dose interferon was administrated in the adjuvant setting. RESULTS: 5-year disease-free survival rate was (85.1 ± 3.0) % in the wide excision and sentinel lymph node biopsy group and (78.4 ± 2.4) % in the wide excision group (hazard ratio, 0.69; p = 0.006). 5-year overall survival rates were similar in the two groups: (88.6 ± 3.0) % vs. (85.1 ± 2.4) %, respectively; hazard ratio, 0.97; p = 0.42. CONCLUSION: Sentinel lymph node biopsy in patients with skin melanoma increases disease-free survival rate without influence on overall survival, confirming the diagnostic, not therapeutical, value of this procedure.

PLASTIC SURGERY OF WOUND DEFECTS WITH FREE GRAFTS AFTER MALIGNANT SKIN TUMORS EXCISION: A PILOT STUDY.

AIM: To evaluate the effectiveness of applying negative pressure bandages (VAC bandage) in patients with malignant skin tumors after closing defects with free skin grafts and to compare it with fixation of skin grafts by the ordinary ointment bandages. MATERIALS AND METHODS: 61 patients with malignant skin tumors who underwent surgical treatment at the National Cancer Institute from 2019 to 2023 were included in the study. For the wound defects closure, the split skin grafts were applied in all patients. At the time of surgery, after closing a wound defect by a split skin graft, a negative pressure dressing (VAC bandage) was applied in 41 patients for 7 days (group 1). In 20 patients, a transplanted skin graft was fixed after surgery by an ordinary ointment pressure bandage (group 2). The immediate results were evaluated one week after surgery. RESULTS: Complete engraftment of the flap in group 1 was observed in 53.7 ± 7.8% cases, in group 2 this result was achieved in 5.0 ± 4.8% patients (p = 0.002). The complete graft necrosis occurred in 1 case in group 1 vs. 2 cases in group 2 (p = 0.496). CONCLUSION: The results of the engraftment in postoperative wounds were significantly better in the VAC-bandage group in terms of the number of the complete engraftments compared to the conventional pressure ointment bandage group.

Safety profile and clinical outcome of adjuvant radiation therapy and intermediate-dose interferon in comparison with intermediate-dose interferon alone in patients with melanoma metastases in regional lymph nodes and unfavorable prognostic factors.

AIM: To assess the safety profile and efficacy of adjuvant radiation therapy and intermediate-dose interferon in comparison with intermediate-dose interferon alone in patients with synchronous and metachronous skin melanoma metastases in regional lymph nodes with unfavorable prognostic factors. MATERIALS AND METHODS: 96 patients with synchronous and metachronous skin melanoma metastases in regional lymph nodes (stage III according to American Joint Committee on Cancer) and unfavorable prognostic factors were randomized in 2 groups: one of them (n = 45) received regional radiation therapy 50-55 Gy and intermediate dose of α2b-interferon (RT + IFN) in adjuvant setting and another one (n = 51) intermediate dose of α2b-interferon alone (IFN). RESULTS: The most common adverse events in both groups were pyrexia and fatigue but grades 3-4 were observed more frequently in the RT + IFN group than in the IFN group (24.4 and 42.2% vs 11.8 and 27.5% respectively). 3-year recurrence-free survival was 78.5% in the RT + IFN group and 73.8% in the IFN group (p = 0.72), 3-year progression-free survival was 63.2% in the RT + IFN group comparing with 57.2% in the IFN group (p = 0.59) and 3-year overall survival was 77.1% and 66.7%, respectively (p = 0.29). Median of recurrence-free, progression-free and overall survival was not reached in any group. CONCLUSIONS: Radiation therapy and intermediate-dose interferon in adjuvant setting tends to improve recurrence-free, progression-free and overall survival comparing with intermediate-dose interferon alone in patients with synchronous and metachronous skin melanoma metastases in regional lymph nodes and unfavorable prognostic factors but it needs further investigation in larger groups of patients.

In-laboratory quality control of nutrients for automatic bacteriology analyzer YUNON®Labstar 50.

The quality of culture media for blood culture was checked: nutrient medium for children with an antibiotic neutralizer for the cultivation of aerobes, nutrient medium with an antibiotic neutralizer for the cultivation of anaerobes, a nutrient medium with an antibiotic neutralizer for the cultivation of aerobes, nutrient medium for the cultivation of aerobes UNONA® used in the automatic bacteriological analyzer JUNONA ®Labstar 50 (SCENKER Biological Technology Co., Ltd. China). Used tenfold dilutions from 18-24 hour cultures of reference strains: ATCC 13124 Clostridium perfringens; ATCC 25285 Bacteroides fragilis; NCTC 194I8 Haemophilus influenzae; ATCC 49619 Streptococcus pneumoniae; ATCC 16615 Streptococcus pyogenes; ATCC 27853 Pseudomonas aeruginosa; ATCC 25923 Staphylococcus aureus; ATCC 25922 Escherichia coli; BKPGU-401/-885-653 Candida albicans; ATCC13813 Streptococcus agalactiae; No. 186 Enterobacter cloacae; ATCC 29212 Enterococcus faecalis; clinical isolates: Acinetobacter lwofii, Enterobacter cloacae, Candida tropicalis. All investigated reference strains were isolated on nutrient media in accordance with their biological properties when inoculated with 50 CFU / ml less than 72 hours later, as stated by the manufacturer. The study has shown that growth factors must be used to test the quality of the culture media with Haemophilus influenzae bacteria and this must be reflected in the manufacturer's instructions.

Burden of malignant melanoma in Ukraine in 2002-2013: incidence, mortality and survival.

BACKGROUND: The malignant melanoma (MM) incidence rates were increasing and later stabilizing in many regions of the world, while in South-Eastern Europe incidence rates are uniformly increasing and mortality rates are higher. AIM: To describe burden of MM in Ukraine in terms of incidence, mortality and survival by sex, age and stage for the period 2002-2013 and compare with European countries. MATERIALS AND METHODS: Database of the National Cancer Registry of Ukraine was used to extract MM incidence cases; number of MM deaths was obtained from the official mortality statistics. Age-standardised and age-specific incidence and mortality rates were calculated by sex, age groups (15-39, 40-59 and 60+); estimated annual percent of change was used to describe trends. Proportions of new cases by stage of disease and calendar period (2002-2007 vs 2008-2013) were compared as well as net survival estimates. RESULTS: In Ukraine, MM was more common in females (age-standardised 5.3 per 100,000 in 2013; annual percent of change 3.5%) than in males (5.1 per 100,000; 4.1%); around 50% of them diagnosed in the age group 60+. The observed increase in proportion of new cases with early stage (I-II) was due to stage II cases. The slight increase in mortality rates in males or stability in females were not accompanied with increase of survival. Net MM survival was consistently lower comparing to European countries. CONCLUSION: More resources should be targeted to increase the capacity of healthcare in diagnostics and treatment of malignant melanoma, but also in promoting healthcare and education in Ukraine.

Search for an optimal test algorithm and characteristic of carbapenemases in nosocomial strains.

Resistance of representatives of the order Enterobacterales to ertapenem 12.1%. The highest frequency of insensitivity to this antimicrobial drug was noted among isolates of K. pneumoniae 29.4%. Among all enterobacterial isolates, resistance to imipenem and meropenem was 17.2% and 20%. The proportion of P. aeruginosa strains is 50.9% resistant to meropenem and imipenem, respectively, and 45% to doripenem. In turn, A. baumannii is resistant to meropenem - 66.6%, imipenem - 63.6%, doripenem - 83.3%. The following resistance genes were found in K. pneumoniae: NDM (n=2), KPC (n=10), OXA (n=1); in P. aeruginosa: VIM (n=8), NDM (n=1), OXA (n=1); A. baumannii OXA (n=1). At present, it is optimal to use molecular methods, in particular real-time PCR, to effectively monitor the distribution of carbapenemase producers, which tend to be widely distributed in a hospital setting. Molecular methods allow you to quickly get the result (during the working day) and give an adequate decision on antibiotic therapy.

Access to innovative medicines for metastatic melanoma worldwide: Melanoma World Society and European Association of Dermato-oncology survey in 34 countries.

According to data from recent studies from Europe, a large percentage of patients have restricted access to innovative medicines for metastatic melanoma. Melanoma World Society and European Association of Dermato-oncology conducted a Web-based survey on access to first-line recommended treatments for metastatic melanoma by current guidelines (National Comprehensive Center Network, European Society for Medical Oncology [ESMO] and European Organization for Research and Treatment of Cancer/European Association of Dermato-oncology/European dermatology Forum) among melanoma experts from 27 European countries, USA, China, Australia, Argentina, Brazil, Chile and Mexico from September 1st, 2017 to July 1st, 2018. Data on licencing and reimbursement of medicines and the number of patient treated were correlated with the data on health expenditure per capita (HEPC), Mackenbach score of health policy performance, health technology assessment (HTA), ASCO and ESMO Magnitude of clinical benefit scale (ESMO MCBS) scores of clinical benefit and market price of medicines. Regression analysis for evaluation of correlation between the parameters was carried out using SPSS software. The estimated number of patients without access in surveyed countries was 13768. The recommended BRAFi + MEKi combination and anti-PD1 immunotherapy were fully reimbursed/covered in 19 of 34 (55.8%) and 17 of 34 (50%) countries, and combination anti-CTLA4+anti-PD1 in was fully covered in 6 of 34 (17.6%) countries. Median delay in reimbursement was 991 days, and it was in significant correlation with ESMO MCBS (p = 0.02), median market price (p = 0.001), HEPC and Mackenbach scores (p < 0.01). Price negotiations or managed entry agreements (MEAs) with national authorities were necessary for reimbursement. In conclusion, great discrepancy exists in metastatic melanoma treatment globally. Access to innovative medicines is in correlation with economic parameters as well as with healthcare system performance parameters. Patient-oriented drug development, market access and reimbursement pathways must be urgently found.

More than 5000 patients with metastatic melanoma in Europe per year do not have access to recommended first-line innovative treatments.

BACKGROUND: Despite the efficacy of innovative treatments for metastatic melanoma, their high costs has led to disparities in cancer care among different European countries. We analysed the availability of these innovative therapies in Europe and estimated the number of patients without access to first-line recommended treatment per current guidelines of professional entities such as the European Society for Medical Oncology (ESMO), the European Organisation for Research and Treatment of Cancer (EORTC), the European Association of Dermato-Oncology (EADO), and European Dermatology Forum (EDF). MATERIALS AND METHODS: Web-based online survey was conducted in 30 European countries with questions about the treatment schedules from 1st May 2015 to 1st May 2016: number of metastatic melanoma patients, registration and reimbursement of innovative medicines (updated data, as of 1st October 2016), percentage of patients treated and availability of clinical studies and compassionate-use programmes. RESULTS: The recommended BRAF inhibitor (BRAFi) + MEK inhibitor (MEKi) combination was both registered and fully reimbursed in 9/30 (30%) countries, and in 13/30 (43%) (all from Eastern Europe) not reimbursed. First-line immunotherapy with anti-PD1 antibodies was registered and fully reimbursed in 14/30 (47%) countries, while in 13/30 (43%) (all from Eastern Europe) not reimbursed. It was estimated that in Europe 19,600 patients with metastatic melanoma are treated, and 5238 (27%) do not have access to recommended first-line therapy. Significant correlation was found between human development index (HDI, UNDP report 2015), (r = 0.662; p < 0.001), health expenditure per capita (r = 0.695; p < 0.001) and the Mackenbach score of health policy performance (r = 0.765; p < 0.001) with the percentage of patients treated with innovative medicines and a number of reimbursed medicines. CONCLUSIONS: Great discrepancy exists in metastatic melanoma treatment across Europe. It is crucial to increase the awareness of national and European policymakers, oncological societies, melanoma patients' associations and pharma industry.

[TARTRAT-RESISTANT ACID PHOSPHATASE AS BONE'S RESORBTION MARKER IN PATIENTS WITH BONE METASTASES].

Determination of serum markets of bone resorption in patients, with renal cancer after radical surgery can improve the accuracy of early diagnosis of bone metastases, assess the extent of metastatic bone lesions, and monitoring of bisphosphonates treatment. These data suggest promising activity for tartrat-resistant acid phosphatase (TRAP-5b) of early detection of bone metastasis.

[Recombinant α-2 interferon in preventing the progression of melanoma].

A brief history of interferon application in the treatment of cutaneous melanoma is represented.

[Experience of microbiologic diagnostics of acute pneumonia cases arose in town Verkhnyaya Pyshma in July-August 2007].

Bacteriologic, serologic, and PCR tests of blood, sputum, serum and autopsy samples from 91 patients were performed during outbreak of pneumonia in town Verkhnyaya Pyshma in July-August 2007. Streptococcus pneumoniae was isolated from 20% of diagnostically meaningful samples of sputum and from 50% of autopsy samples. Diagnosis of Legionnaires' disease was confirmed in 48% of cases. It was shown that association of Streptococcus pneumoniae and Legionella pneumophila determined the affect during such pneumonia. Need for establishment of diagnostic procedure for patients with pneumonia including those caused by atypical agents was revealed.

[Primary multiple malignant neoplasms in patients with skin melanoma].

The problem of primary multiple malignant tumor (PMMT) of skin melanoma in Ukraine is analyzed. During the period from 2000 to 2006, 16760 cases of skin melanoma have been diagnosed, and in 873 patients from them PMMT has been registered. So, the part of the patients with multiple tumors among all patients with skin melanoma was 5.2%. Most often PMMT appears in the case of skin melanoma of head and neck (6.6 +/- 0.4%). Most commonly skin melanoma is accompanied by other skin malignant neoplasms (40.9 +/- 1.6% of all PMMT cases). Upon malignant skin melanoma, PMMT occurs more often in males (5.7 +/- 0.7%) than in females (4.9 +/- 0.7%). Most often the diagnosis of skin melanoma at PMMT is detected synchronously (48.3 +/- 1.6%), and simultaneous detection of PMMT predominates in all polyneoplasms and in all age groups. The most favourable course of skin melanoma is characteristic for metachronous cancer of II type when melanoma is diagnosed after manifestation of other malignant tumor.

[Cases of primary multiple metachronous skin melanoma].

The article presents medical cases of primary multiple metachronous skin melanoma, which is rarely come across in oncological practice and presents interest for oncologists.