ОТБОР БОЛЬНЫХ РЕЗИСТЕНТНОЙ АРТЕРИАЛЬНОЙ ГИПЕРТЕНЗИЕЙ ДЛЯ ВЫПОЛНЕНИЯ РЕНАЛЬНОЙ ДЕНЕРВАЦИИ

Aim. To develop an optimized scientifically based approach to medical and diagnostic measures before renal denervation.Methods. 91 patients with a previously diagnosed primary arterial hypertension aged 54.2 (52.0, 69.3) yearshistory of arterial hypertension was 11.4±4.2 years. 57 (62.6%) patients had asymptomatic lesions of target or-gans. 34 (37.4%) were present with associated clinical conditions. The average number of classes of antihyper-tensive drugs taken by patients was 4±1.2. 18 patients (19.8%) received aldosterone antagonists. All patients were included in the study. The duration of the positive underwent standard clinical, laboratory and instrumental tests. The quality of life was assessed using the SF-36 questionnaire. Patients’ adherence to treatment was eval-uated using the Morisky-Green test. After therapy optimi-zation and a number of additional diagnostic procedures, true resistant arterial hypertension was detected in 19 pa-tients, of whom 9 were excluded from the study. 4 patients were excluded because of specific anatomy, and 5 patients were allergic to the contrast media.Results. Optimization of the diagnostic and medical algorithm for managing patients with arterial hy-pertension allowed identifying patients with secondary arterial hypertension, accounted to 8.8% of the study sample, as well as achieving significant reduction of blood pressure according to the 24-hour blood pressure monitoring findings: SBP by 34 ± 12 mm Hg, and DBP by 12 ± 4 mm Hg, compared to the initial values (p = 0.046). The obtained results are comparable in the groups with high and low adherence. 54 patients (77.1%) achieved blood pressure targets. The study groups demonstrated significant improvements of the quality of life and adherence to treatment. The proportion of patients with true resistant arterial hypertension has been identified.Conclusion. The presented algorithm of selecting patients for renal denervation allows to optimize the management strategy inpatients, who are suspected to suffer from resistant arterial hypertension, and to per-form targeted interventions.Цель. Разработка оптимизированного научно-обоснованного подхода к лечебно-диагностическим мероприятиям перед выполнением РД.Материалы и методы. В исследование включен 91 пациент с ранее диагностированной первичной АГ в возрасте 54,2 (52,0; 69,3) лет. Длительность анамнеза АГ составила 11,4±4,2 года. 57 (62,6%) пациентов имели признаки бессимптомного поражения органов-мишеней, 34 (37,4%) ассоциированные клинические состояния. Среднее количество классов принимаемых антигипертензивных средств составило 4±1,2; 18 человек (19,8%) получали антагонисты альдостерона. Всем пациентам выполнялись стандартные клинико-анамне-стические, лабораторные и инструментальные тесты, производилась оценка качества жизни с применением опросника SF-36 и оценка комплаенса с использованием теста Мориски-Грина. После оптимизации терапии и ряда дополнительных диагностических процедур, истинная резистентная АГ была выявлена у 19 пациентов, 9 из которых были исключены из дальнейшего исследования, 4 по анатомическому критерию, 5 ввиду наличия в анамнезе аллергических реакций на контрастное вещество.Результаты. Оптимизация диагностического и лечебного алгоритма ведения пациентов с АГ по-зволила выявить пациентов с вторичными вари-антами АГ, которые составили 8,8% в исследуемой выборке, а также достичь значимой динамики сни-жения АД по данным СМАД: САД на 34±12 мм рт. ст, ДАД на 12±4 мм рт. ст. от исходного (р=0,046). Результаты сопоставимы в группах с высоким и низким комплаенсом. У 54 человек (77,1%) удалось достичь целевых значений АД. Была выявлена до-стоверная динамика улучшения показателей каче-ства жизни и уровня приверженности к лечению в исследуемой группе. Также была выявлена целевая для выполнения РД группа пациентов с истинной резистентной АГ.Выводы. Представленный алгоритм отбора па-циентов для выполнения вмешательства позволяет оптимизировать тактику ведения пациентов, у ко-торых предполагается наличие резистентной АГ, и позволяет более целенаправленно применять ин-тервенционный подход

FALCON: A phase III randomised trial of fulvestrant 500 mg vs. anastrozole for hormone receptor-positive advanced breast cancer

Background: This Phase III, randomised, double-blind, multicentre trial (FALCON; NCT01602380) compared the selective estrogen receptor (ER) degrader (SERD) fulvestrant with anastrozole in patients with ER- and/or progesterone receptor-positive locally advanced or metastatic breast cancer who had not received prior hormonal therapy. Methods: Patients were randomised 1:1 to fulvestrant (500 mg IM on Days 0, 14, 28, then each 28 days) or anastrozole (1 mg daily). The primary endpoint was progression-free survival (PFS), assessed via RECIST 1.1, surgery/radiotherapy for disease worsening, or death. Secondary endpoints were: overall survival (OS); objective response rate (ORR, complete response [CR] or partial response [PR]); duration of response (DoR); expected DoR (EDoR); clinical benefit rate (CBR; CR, PR, or stable disease ≥24 weeks); duration of clinical benefit (DoCB); expected DoCB (EDoCB); health-related quality of life (HRQoL); and safety

ABOUT THE SPECIAL INVESTIGATIONS OF THE PROTECTION OF THE TECHNICAL SECURITY SYSTEMS AGAINST INFORMATION LEAKAGE DUE TO THE ACOUSTO-ELECTRICAL TRANSFORMATIONS

None of the critically important facilities can operate without the engineered safety system. Functionally varied security networks or a fire alarm system can refer to this system as well as safety and reliability which are provided by secured energy, water and heating supply. In the process of attestation according to the requirements of information security of information objects with such technical means, it is necessary to conduct special investigations of protection against leakage of acoustic speech information through the channels of the acousto-electrical transformations (AET). There are major aspects in the data leak via AET, which currently include the following: lack of and /or obtaining legal and safety norms to regulate specified parameters; lack of the automated hardware and software system for some AET variations to carry out measurements; lack of specified safety equipment for some AET variations; lack of shelter security units; high costs of AET measurement and control units; and low measurement repeatability

BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase [Corrigendum]

Larsen S, Butthongkomvog K, Manikhas A, et al. Breast Cancer: Targets and Therapy. 2014;6:179–189.On page 184 there is an error in Figure 3A. The error consists of a yellow bar at +16 days in the placebo group. Read the original articl

BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase

Stig Larsen,1 Kritiya Butthongkomvong,2 Alexey Manikhas,3 Ekaterina Trishkina,4 Elena Poddubuskaya,5 Marina Matrosova,6 Vichien Srimuninnimit,7 Steen Lindkær-Jensen81Department of Controlled Clinical Trials and Biostatistics, Centre for Epidemiology and Biostatistics, University of Life Science, Oslo, Norway; 2Udonthani Cancer Hospital, Udonthani, Thailand; 3Department of Oncology, City Clinical Oncology, Dispensary, St Petersburg, Russia; 4Department of Oncology, Leningrad Regional Oncology Centre, St Petersburg, Russia; 5Department of Oncology, Unit of Russian Academy of Medical Science, Moscow, Russia; 6Department of Oncology, N Novgorod Regional Oncology Dispensary, Novgorod, Russia; 7Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand; 8Department of Surgery and Cancer, Imperial College, Hammersmith Hospital, London, UKAbstract: The aims were to compare the efficacy and tolerability of a new benzene-poly-carboxylic acids complex with cis-diammineplatinum (II) dichloride (BP-C1) versus placebo and to investigate the long-term tolerability of BP-C1 in the treatment of patients with metastatic breast cancer.Material and methods: A randomized, double-blind, placebo-controlled multicenter study was performed with a semi-crossover design. Patients allocated to placebo switched to BP-C1 after 32 days of treatment. Patients who completed 32 days of BP-C1 treatment were offered the opportunity to continue on BP-C1 for an additional 32 days in an open-label extension. Patients were then followed up for another 28 days. Thirty patients were given daily intramuscular injections of 0.035 mg/kg of body weight BP-C1 or placebo for 32 days. Biochemistry, hematology, National Cancer Institute Common Terminology Criteria for Adverse Events (CTC-NCI), European Organisation for Research and Treatment of Cancer quality of life questionnaire (QOL-C30 and the breast-cancer–specific BR23) data were recorded at screening and after every 16 days of treatment. Computed tomography was performed at screening and every 32 days.Results: The sum of target lesions increased 2.4% in the BP-C1 group and 14.3% in the placebo group. Only the increase in the placebo group was significant (P=0.013). The difference between the groups was significant in favor of BP-C1 (P=0.04). There was a significant difference (P=0.026) in favor of BP-C1 regarding Response Evaluation Criteria In Solid Tumors (RECIST) classification. The sum of lesions increased slightly in the patients receiving 64 days of continuous BP-C1 treatment, of whom 68.4% were classified as responders. The sum CTC-NCI toxicity score increased nonsignificantly in the BP-C1 group but significantly in the placebo group (P=0.05). The difference in increase between groups did not meet the level of significance (P=0.12). The sum toxicity score was reduced in the patients receiving 64 days of BP-C1 from 9.2 at screening to 8.9 at Day 48, but it increased again to 10.1 by Day 64 and 10.6 during the 28-day follow-up. "Breast cancer-related pain and discomfort" and "Breast cancer treatment problem last week" were significantly reduced (P=0.02) in the BP-C1 group but increased slightly in the placebo group; between-group differences were significant in favor of BP-C1 (P=0.05). "Breast cancer related pain and discomfort", "Breast cancer treatment problem last week," and "Physical activity problem" were significantly reduced during the 64 days of BP-C1 treatment (P≤0.05).Conclusion: For patients suffering from stage IV metastatic breast cancer, treatment with BP-C1 reduces cancer growth, is well tolerated, improves quality of life, and produces few adverse events, which were mainly mild and manageable.Keywords: tumor growth reduction, improved Quality of Life, safe, few transient adverse effect

A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results

Background: The equivalent efficacy between SB3, a proposed trastuzumab biosimilar, and the trastuzumab reference product (TRZ) in terms of the breast pathologic complete response rate after neoadjuvant therapy in patients with early or locally advanced human epidermal growth factor receptor 2-positive breast cancer was demonstrated in the previous report. Here, we report the final safety, immunogenicity and survival results after neoadjuvant-adjuvant treatment. Patients and methods: Patients were randomised 1 : 1 to receive neoadjuvant SB3 or TRZ for 8 cycles concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5fluorouracil/epirubicin/cyclophosphamide). Patients then underwent surgery, followed by 10 cycles of adjuvant SB3 or TRZ as randomised. End-points included safety, immunogenicity, event-free survival (EFS) and overall survival through the adjuvant period. Results: Of 875 patients randomised, 764 (SB3, n = 380; TRZ, n = 384) completed the study. The median follow-up duration was 437 days in the SB3 group and 438 days in the TRZ group. The incidence of treatment-emergent adverse events was comparable between groups (SB3, 97.5%; TRZ, 96.1%) during the overall study period. Up to the end of study, the overall incidence of antidrug antibody was low in both treatment groups (3 patients each). EFS was comparable between groups with a hazard ratio (SB3/TRZ) of 0.94 (95% confidence interval, 0.59-1.51) and EFS rates at 12 months of 93.7% for SB3 and 93.4% for TRZ. Conclusions: Final safety, immunogenicity and survival results of this study further support the biosimilarity established between SB3 and TRZ. (C) 2018 Elsevier Ltd. All rights reserved