Background Bevacizumab is an antiangiogenic recombinant humanized monoclonal antibody that inhibits tumor growth. FKB238, a bevacizumab biosimilar, has analytical pharmacokinetic and safety profiles similar to those of bevacizumab. Objective This phase III trial (NCT02810457) compared the efficacy and safety of FKB238 with that of bevacizumab in patients with advanced/recurrent non-squamous non-small-cell lung cancer (non-sq-NSCLC). Methods This global, multicenter, double-blind, parallel, randomized, comparative clinical trial enrolled and randomized patients with advanced/recurrent non-sq-NSCLC to receive intravenous infusions of either FKB238 15 mg/kg or bevacizumab 15 mg/kg. All patients received intravenous infusions of paclitaxel 200 mg/m 2 and carboplatin (area under the curve 6.0) immediately prior to investigational products for 4-6 cycles. FKB238 and bevacizumab were administered on day 1 of each 21-day cycle until objective progressive disease by RECIST version 1.1 or other discontinuation criteria were met. The primary efficacy endpoint was overall response rate (ORR), including complete and partial response and based on blinded independent central review assessment. Other efficacy determinations included progression-free survival (PFS), overall survival (OS), and immunogenicity. Adverse events and severity were reported. ResultsThe ORR for the intent-to-treat (ITT) population (N = 731) was 51.6% in the FKB238 arm (N = 364) and 53.7% in the bevacizumab arm (N = 367). The FKB238:bevacizumab ORR ratio (ITT population) was 0.96 (90% confidence interval [CI] 0.86-1.08), and the difference in ORR (per-protocol set) between FKB238 and bevacizumab was − 0.02 (95% CI − 0.09 to 0.06). Both CIs fell within the prespecified equivalence margins. Estimated median PFS was 7.72 and 7.62 months in the FKB238 and bevacizumab arms, respectively (hazard ratio 0.97; 95% CI 0.82-1.16). Treatment-emergent adverse events (TEAEs) were reported for 94.2% and 95.1% of patients in the FKB238 and bevacizumab arms, respectively. Grade 3 or higher TEAEs were reported for 53.6% and 55.5% of patients in the FKB238 and bevacizumab arms, respectively. Serious TEAEs were reported for 25.1% and 26.0% of patients treated with FKB238 and bevacizumab, respectively. Conclusions Efficacy equivalence was demonstrated between the two drugs, and safety profiles were similar. There were no meaningful differences in efficacy and safety between FKB238 or bevacizumab in patients with non-sq-NSCLC. Trial registration number NCT02810457.

AimTo assess the prognostic value of lactate level for mortality in patients with pulmonary embolism (PE) and Pulmonary Embolism Severity Index (PESI) I-III and its independence of gas-analysis parameters and acid-base status.MethodsThis prospective observational study was conducted at the University Clinical Hospital Mostar from 2013 to 2017. On the first day after PE diagnosis, 1.5 mL of arterial blood was collected from 103 patients with PE. Partial pressure of oxygen in arterial blood, partial pressure of carbon dioxide in arterial blood, blood pH value, concentration of bicarbonates in arterial blood (HCO3-), base deficit, and oxygen saturation were analyzed. Lactate levels were assessed using blood samples taken from the cubital vein. Logistic regression analysis was used to assess the predictive value of gas-analysis variables, lactate level, PESI score, age, and sex for in-hospital death due to PE.ResultsThe mortality in the group of PE patients was 19.1% (18 of 103 patients). Lactate level was an independent predictor of mortality (P = 0.002, odds ratio 0.06). HCO3- was also found to be a significant predictor (P = 0.022, odds ratio 2.4). Lactates were independent of other variables. Other gas-analysis parameters were not significant predictors of mortality.ConclusionIn PE patients at low-intermediate risk of mortality (PESI I-III), lactate level was associated with a short-term mortality, independently of other gas-analytic parameters.Oxford Centre for Evidence-based Medicine level of evidence: 2.

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Tuberculosis (TB) is one of the oldest, the most expanded and the most lethal diseases in human history. Although Koch’s discovery of the TB causative agent (1882) represented a great progress in the fight against this infectious disease, it took a significant amount of time to reduce morbidity and mortality in the world. In Bosnia and Herzegovina (B&H) it was necessary to implement actions in the form of education where the popularization of measures of recognition, treatment and preventing the disease was done. After the Annexation of B&H to Austro-Hungarian (1908) began an organized fight against TB. Dr. S. Kukric was a particularly prominent individual, putting his effort by working in clinics, through his lectures and numerous popular research papers on tuberculosis. He was followed by many colleagues working inexhaustibly while facing the high incidence of TB and the difficult social situation in B&H. Although this disease is old, at the end of the 20th century a new TB appeared, with new challenges and new, even grater problems. Significant achievement and great progress in the treatment and control of TB infection was achieved by implementing the direct observed short course treatment (DOTS from 2006.) Still, there is a too high incidence of TB that becomes again a serious threat, together with new problems and difficult economic and social situation. Nowadays in Federation of B&H the guidelines of World Health Organization on reinforcing the DOTS strategy are being daily implemented, including multidrug-resistant (MDR) TB and infection control.

Every successful health care system should be based on some general humanistic ideals. However, the nationally organized health care systems of most European countries usually suffer from a deficiency in common ethical values based on universal human principles. When transitional societies, such as that of Bosnia-Herzegovina are concerned, health care organizational models are even more dysfunctional. The sources of a dysfunction in medical care system of Bosnia-Herzegovina are manifold and mutually controversial, including a lack of shared principles, an inappropriate involvement of politicians in medical care and practice, administrative difficulties arising from superficial communication systems, as well as economic limits concerned with the financing of health care. The deficiency of a moral culture of medicine, which is correlated to a general collapse of morality is also responsible for many problems affecting various aspects of life including medical care. Hence, medical ethics from a virtue perspective is becoming an important ingredient of any improvement deigned to provide better-quality medical care. The aim of this paper is to underline the influence of humanism on the organization of health care systems and the ethics of medical interrelations in the society of Bosnia-Herzegovina. It is not intended to diagnose or resolve the problems, but to analyze them. It is also a critique of specific socio-political-economic influences on this health care system, inquiring if well-educated individuals in the virtues, which are involved in medical practice and education, would counteract them. In conclusion, humanism creates a universal ethical structure, which is based on human values such as fidelity, trust, benevolence, intellectual honesty, courage, compassion and truthfulness. These values should represent the standard around which medical care is organized. Since the health care system in Bosnia-Herzegovina is not entirely founded upon humanistic ideals, addressing the socio-political-economic conditions that constantly undermine those values is a prerequisite for any much-needed improvements of the medical care.

The aim:The aim of this study is to investigate the correlation between the morning level of serum cortisol and perceptive experience of optimism in a selected group of 60 patients with newly diagnosed cancer who were treated at Mostar University Clinical Hospital during a one-month period.Patients and methods:The morning level of serum cortisol was measured in all patients following the verification of oncological disease. The patients also filled out a questionnaire of socio-demographic data, as well as the scales for optimism/pessimism assessment.Results:The average morning serum cortisol level was within the reference values in the majority of patients, independently of their perceptive experience of optimism/pessimism. There was no significant difference in the morning level of serum cortisol among the subgroups of patients high and low on the scale of optimism, as well as the scale of pessimism. No correlation existed between the serum cortisol morning level and expressed optimism/pessimism, as well. The great majority of respondents had secondary and lower education, was retired or unemployed, and suffered lower socio-economic conditions of life. Therefore, their access to medical information and their knowledge of cancer modern treatment options and possibilities were restricted, what may also have an influence onto perceptive experience of optimism/pessimism.Conclusion:The results concerned with the perceptive experience of optimism/pessimism assessment were not a consequence of stress reaction but they were more correlated to general personal characteristics, the level of education, and socio-economic status of patients. The results do not confirm the impact of morning serum cortisol level onto physiological reactions to stressful conditions and situations in selected group of patients with de novo carcinoma.

Background: A few studies described surgical personality, inquiring all its dimensions, as well as surgeons’ psychomotor abilities and propensity for teamwork. Even fewer papers examined their spirituality and its impact on the effectiveness of daily surgical labor. The aim of this paper is to evaluate personality traits, psychomotor abilities and spirituality in surgeons and surgical residents, as well as propensity for teamwork in relation to their work experience.Methods: The study involved 15 male surgeons aged 40-49 and 15 male surgical residents aged 30-39, who were divided into the case and control group according to their age. The Eysenck Personality Questionnaire, visual stimulus response rate, oculomotor, and manual ability assessments, movement stability testing, intrinsic/extrinsic religious orientation, and teamwork efficiency questionnaires were used. Results: No statistically significant differences in personality traits, psychomotor abilities, religious orientation, and propensity for teamwork were recorded between surgeons and residents. These may support the specialty choice, and selection of surgical teams helping them to make important professional decisions, which well-affect the patients’ outcome.

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