Analysis of long-term treatment results of 101 primary gastric cancer patients at various stages of the tumor process followed during 1 - 41 months (median - 6,4 months) from the onset of specific treatment are presented depending on the levels of soluble forms (s) of PD-1 receptor and its ligand PD-L1 in blood plasma. Overall survival assessed by Kaplan-Meyer analysis and with the help of Cox multiparametric regression model was applied as the criterion of prognostic value. It was found that at high (≥ 35 pg/ml) sPD-L1 levels in blood plasma, the overall survival of patients with gastric cancer was statistically significantly lower than at the marker’s levels below 35 pg / ml (p <0.045): 1-year survival comprised 78 and 96%, 2-year - 52 and 78%; 3-year - 40 and 61% at high and low sPD-L1 respectively. Median survival of patients with high plasma sPD-L1 comprised 29 months, of those with low sPD-L1 was not achieved during the whole follow-up period. This trend was observed not only in the total group of stage I-IV gastric cancer patients, but also in patients at the early stages of the disease, though sPD-L1 did not show an independent prognostic value in multiparametric model. At the same time, the overall survival of patients with gastric cancer did not depend on the baseline levels sPD-1 in blood plasma. Thus, soluble ligand sPD-L1 can be considered as a potentially valuable factor for prognosis of gastric cancer patients’ survival, and, probably, of anti-PD-1/PD-L1 treatment efficiency, but further studies and patients’ monitoring are required to prove this statement.
Results of comparative ELISA investigation of pretreatment sPD-1 and sPD-L1 content in blood plasma of 100 gastric cancer patients at various disease stages aged 25 to 81 years are presented. Control group included 60 practically healthy donors aged 18 - 68 years. Plasma sPD-L1 concentrations did not differ between gastric cancer patients and control group, and sPD-1 levels were statistically significantly lower in patients than in healthy donors (p<0.0001). Positive correlation (R=0.38; p=0.003) was revealed between plasma sPD-1 and sPD-L1 levels in control group and negative (R= -0.26; p=0,009) - in gastric cancer patients. ROC curve revealed the best sPD-1 cut-off level (< 21 pg/ml) with 77% sensitivity and 63.3% specificity, which is not sufficient for its application as diagnostic marker. Statistically significant increase of plasma sPD-L1 from stage I to stage IIIC (R=0.50; p=0.000011) was found. Analysis of associations between the evaluated markers’ levels and indices of gastric cancer expansion according to TNM system revealed statistically significant positive associations of plasma sPD-L1 levels with T (tumor invasion depth) and N (number of affected lymph nodes) indices: R=0.33; p=0.00093, and R=0.27; p=0.0099 respectively. sPD-L1 level was significantly increased in patients with low differentiated adenocarcinoma and cricoid-cell cancer as compared to highly differentiated adenocarcinoma (p=0.02 and p=0.004 respectively); in patients with cricoid-cell cancer it was also higher than in those with moderately differentiated adenocarcinoma (p=0.043) and undifferentiated cancer (p=0.049). Plasma sPD-1 level did not depend on disease stage, TNM system indices and tumor histological structure. Thus, soluble ligand sPD-L1, but not its receptor sPD-1, plasma level is increased in patients with unfavorable clinical and morphological characteristics, may be regarded as potentially valuable prognostic factor for gastric cancer patients’ survival, and probably as a predictor of anti - PD-1/PD-L1 treatment efficiency.
The huge global burden of oncological diseases is growing and measures to counter this complex challenge are high on national health agendas. The Russian National Long-Term Oncology Strategy 2030 defines priorities, goals and directions in the fight against cancer. Italso contains action plans for more effective prevention, earlier and more specific diagnosis and more effective treatment options. Against this backdrop, experts now suggest to complement standard oncology treatment strategies by adding Patient Blood Management (PBM). For many clinical disciplines where a low blood count and considerable blood loss are commonly encountered, this bundle of care is the new standard. Based on clinical and scientific evidence, it aims to optimise medical and surgical patient outcomes by clinically managing and preserving a patients blood. The principles of this comprehensive concept can and must be transferred to oncology, thus offering value in improving cancer care and the efficacy of medical institutions. Accumulating evidence demonstrates that anaemia and iron deficiency, but also thrombocytopenia, blood loss and coagulopathy are independent risk factors for adverse patient outcomes including morbidity, mortality, reduced quality of life and prolonged average length of hospital stay in both surgical and medical patients. For the timely and effective detection and correction of these risk factors, an international network of multi-disciplinary clinicians and researchers has developed PBM. The rapidly growing body of evidence for PBM not only shows improved patient outcomes, but also reduced resource utilisation including the use of allogeneic blood components. The reduction of allogeneic blood transfusion further improves patient safety and outcomes, since transfusion is another independent risk factor for adverse outcomes. Supported by WHO endorsements and following the recommendations of an increasing number of state or national health authorities, PBM is about to become a new standard of care. However, even though the aforementioned risk factors are highly prevalent in oncology settings due to chemo-/radiotherapy and the pathology of the disease, the integration of PBM in standard oncology treatment pathways is lagging behind. Thus, and in support of the Russian National Long-Term Oncology Strategy 2030 to improve quality of oncological care, with the support of the National Association of Specialists in PBM (NASPBM), the PBM Oncology Working Group of the Russian Federation was created, consisting of national and international experts in oncology and PBM. On July 9, 2020, the Working Group met to discuss the rationale for PBM in oncology and to assess the need to implement PBM in Russian oncology care. As a result, the Group recommended to include PBM as an integral part of standard oncology treatment pathways, delineated the action required from facilitating stakeholders in the Russian Federation, determined a roadmap for implementation and developed a national resolution as a call to action on the matter. Presented herein, this resolution acknowledges the global and local impetus to reduce cancer mortality, and the rationale for PBM interventions to improve patient outcomes and alleviate the social and economic burden of cancer on the healthcare system.
Background. Medical practice requires decisions that are risky in nature and their positive outcome cannot be guaranteed. The reasons for this can be varied, but also with a proper and professional approach by the treating attending physician and other medical personnel adverse effects of the treatment or research carried out should not also be interpreted as criminal acts, which justifies a thorough examination of the attributes and types of reasonably medical risks and the conditions for their legitimacy. Materials and methods. An analysis of the sources of legal regulation of medical activity, including criminal legislation, was carried out and law enforcement practice was studied. The paper used the formal-legal method to identify and specify the conditions for the legitimacy of medical occupational risks. Results. Occupational medical risk is a type of reasonable risk, that is a circumstance precluding criminality of an act, and depending on the socially useful purpose of the intervention in the functioning of the human body, it can be innovative and treatment. Conclusion. Qualification of occupational medical risk as a reasonable risk requires taking into account consideration of the full content of the situation of its application in each case. In doing so, there is no need for a separate regulation on the legitimacy of medical risk, but Article 41 of the Criminal Code may be supplemented by a condition to exclude informed consent of the patient or his statutory representative, when it is carried out on emergency evidence to eliminate the threat to a person’s life.
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