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Background. Lung cancer represents the main cause of cancer-related mortality at a worldwide level and ranks second in global incidence statistics. The therapeutic management of non-small cell lung cancer (NSCLC) has been substantially modified by the development of immune checkpoint inhibitors (ICI), nivolumab, pembrolizumab, durvalumab and atezolizumab. In Romania, the reimbursement of healthcare costs for immune checkpoint inhibitors has started since late 2017. Aim of the study. The assessment of efficacy, safety profile, overall survival (OS) and progression-free survival (PFS) from real-world data for nivolumab as second-line therapy for advanced and metastatic NSCLC. Our real-world study was conducted between 1.01.2018 and 31.12.2020, right after the approval of nivolumab in Europe for metastatic NSCLC. Methodology. For data analysis, we used R programming language, version 3.6.2, the Excel application in Microsoft 365 for Enterprise pack. Results. We studied 34 participants from our lot. Nivolumab was administered from second line and beyond. The average age was 65.5 years old. The majority of patients had multiple comorbidities. The histopathology was represented by 56% non-squamous NSCLC, and 44% squamous NSCLC. The overall survival for nivolumab therapy was 72.3 weeks (18.07 months). The overall survival for non-smokers was 32.5 weeks (8.12 months) versus 93 weeks for smokers (23.25 months). The overall survival for women was 15.3 weeks (3.8 months) and for men this value could not be reached. The overall survival for squamous carcinoma was 72.3 weeks (18.1 months), and for non-squamous carcinoma, it was 93 weeks (23.25 months). Median PFS was 17.3 weeks (4.3 months). Conclusions. ICI with nivolumab administered from second line and beyond had a favorable safety profile and manageable adverse events, similar to those described in pivotal studies, making them a reasonable choice in pretreated, frail and elderly patients. Distinctively, our real-world data regarding OS and PFS did not show the same advantage magnitude as seenin CheckMate 017 and CheckMate 057 studies. [ABSTRACT FROM AUTHOR]

Real-world data (RWD) and observational studies (OS) are increasingly important in current clinical research. In this article, we have summarized the definition of the two means of research, we have defined them, and we have shown how they can determine results that support the results of clinical randomized trials. We have also shown the fact that RWD and OS can partially or totally disprove controlled randomized clinical trials (CRCT). The latter remain the gold standard in research regarding the efficacy and safety of innovative drugs. We present the plan for conducting observational studies, which is based on a checklist recognized by a large community of researchers. We also present the types of observational studies that can be used in clinical research. Finally, we followed the results obtained in the clinical trials performed in non-small cell lung cancer (NSCLC). The analysis was done on the most important studies published online. The conclusions are in favor of using RWD and OS to verify the results published after CRCT. [ABSTRACT FROM AUTHOR]

This short review analyzes several studies published in the last three years entirely on the internet. We sought to extract the main clinical characteristics of cardiac toxicity and the main investigations necessary for diagnosis, which are currently not standardized. Finally, we presented the management of the main toxic cardiac manifestations induced by checkpoint inhibitors (ICI) in cancer immunotherapy. The main references were made to myocarditis, which is the most frequently reported toxicity. Essentially, the management of the cardiac toxicities of ICI is done by following the cardiological protocols to which corticotherapy is added in high doses. Considering the complexity of diagnosis and treatment, a new structure was developed within cardiology, namely cardio-oncology. [ABSTRACT FROM AUTHOR]