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11.
Treatment patterns, testing practices, and outcomes in the pre-FLAURA era for patients with EGFR mutation-positive advanced NSCLC : a retrospective chart review (REFLECT)
Alfredo Addeo, Maximilian J Hochmair, Urška Janžič, Elizabeth Dudnik, Andriani Charpidou, Adam Płużański, Tudor Ciuleanu, Ivan Shterev Donev, Judith Elbaz, Jørgen Aarøe, René Ott, Nir Peled, 2021, original scientific article

Abstract: Background. Immunotherapy with immune checkpoint inhibitors (ICIs) recently became the standard treatment for patients with advanced non-small cell lung cancer (NSCLC). Here, we present the first results of a real-world observational study on the effectiveness of ICI monotherapy in patients with advanced NSCLC treated at a single academic center in a Central and Eastern European (CEE) country. Materials and methods. Overall, 66 consecutive patients with advanced NSCLC treated with ICIs in everyday clinical practice, either with first-line pembrolizumab (26 patients) or second-line atezolizumab, nivolumab, or pembrolizumab (40 patients), from August 2015 to November 2018, were included. All data were retrieved from a hospital lung cancer registry, in which the data is collected prospectively. Results. Included patients had a median age of 64 years, most were male (55%), 6% were in performance status >/=2, and 18% had controlled central nervous system metastases at baseline. In first-line, the median progression-free survival (mPFS) was 9.3 months, while the median overall survival (mOS) was not reached. The 1-year overall survival (OS) was 62%. In second-line, the mPFS and mOS were 3.5 months and 9.9 months, respectively, with a 1-year OS of 35%. In the overall population, adverse events of any grade were recorded in 79% of patients and of severe grade (3-4) in 12% of patients. Conclusion. The first real-world outcomes of NSCLC immunotherapy from a CEE country suggest comparable effectiveness to those observed in clinical trials and other real-world series, mainly coming from North America and Western European countries. Further data to inform on the real-world effectiveness of immunotherapy worldwide are needed.
Keywords: non-small cell lung carcinoma, immunotherapy, advanced non-small cell lung cancer, real-world data, Europe, Central Europe, Eastern Europe
Published in DiRROS: 15.12.2021; Views: 770; Downloads: 405
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12.
Corythucha arcuata (Say, 1832) (Hemiptera, Tingidae) in its invasive range in Europe : perception, knowledge and willingness to act in foresters and citizens
Flavius Balacenoiu, Anže Japelj, Iris Bernardinelli, Bastien Castagneyrol, György Csóka, Milka Glavendekić, Gernot Hoch, Boris Hrašovec, Silvija Krajter Ostoić, Márton Paulin, David Williams, Johan Witters, Maarten De Groot, 2021, original scientific article

Abstract: The oak lace bug (OLB) Corythucha arcuata (Say, 1832) is an invasive alien species (IAS) that potentially could have many negative impacts on European oak health. Certain measures can be applied to counteract these effects. However, these measures may not be acceptable for forest managers or other stakeholder groups, such as private forest owners, environmental NGOs or the general public. Thereby, we set out to study the perception and knowledge of foresters and other stakeholders on the health status of European oak forests affected by oak lace bug and to investigate what forest health management measures would be acceptable to these target groups. An online survey questionnaire was designed and distributed via social networks, as well as professional networks via e-mails. The survey questionnaire was completed by 2084 respondents from nine European countries: Austria, Croatia, Belgium, France, Hungary, Italy, Romania, Serbia and Slovenia. Even though only a little over 60% of respondents reported they had noticed the discolouration of oak leaves caused by OLB, almost all (93%) considered it to be a problem. As respondents come from a country where C. arcuata is widespread and established, people%s general knowledge and awareness of OLB began to increase. The survey revealed that foresters thought that the insect affected photosynthesis, acorn crop and the aesthetics of the trees, but cannot cause death of trees. However, they assume that the value of the wood would decrease (this fact is also supported by the respondents who are connected to an environmental NGO), but that OLB does not affect property value. However, forest owners claim that the value of the property can be affected and that people would avoid entering the forest. In terms of potential control methods, respondents preferred biological or mechanical measures over chemical ones. We consider this study to be a good basis for further research on the topic of perception, knowledge and attitudes related to OLB since we can expect that the IAS, such as OLB, will certainly spread to European countries that were not included in this survey.
Keywords: attitude, citizen knowledge, Europe, forest health, IAS control measures, invasive alien species, survey
Published in DiRROS: 28.10.2021; Views: 1136; Downloads: 707
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13.
Immunotherapy for metastatic non-small cell lung cancer : real-world data from an academic Central and Eastern European center
Marija Ivanović, Lea Knez, Ana Herzog, Mile Kovačević, Tanja Čufer, 2021, original scientific article

Abstract: Background. Immunotherapy with immune checkpoint inhibitors (ICIs) recently became the standard treatment for patients with advanced non-small cell lung cancer (NSCLC). Here, we present the first results of a real-world observational study on the effectiveness of ICI monotherapy in patients with advanced NSCLC treated at a single academic center in a Central and Eastern European (CEE) country. Materials and methods. Overall, 66 consecutive patients with advanced NSCLC treated with ICIs in everyday clinical practice, either with first-line pembrolizumab (26 patients) or second-line atezolizumab, nivolumab, or pembrolizumab (40 patients), from August 2015 to November 2018, were included. All data were retrieved from a hospital lung cancer registry, in which the data is collected prospectively. Results. Included patients had a median age of 64 years, most were male (55%), 6% were in performance status >/=2, and 18% had controlled central nervous system metastases at baseline. In first-line, the median progression-free survival (mPFS) was 9.3 months, while the median overall survival (mOS) was not reached. The 1-year overall survival (OS) was 62%. In second-line, the mPFS and mOS were 3.5 months and 9.9 months, respectively, with a 1-year OS of 35%. In the overall population, adverse events of any grade were recorded in 79% of patients and of severe grade (3-4) in 12% of patients. Conclusion. The first real-world outcomes of NSCLC immunotherapy from a CEE country suggest comparable effectiveness to those observed in clinical trials and other real-world series, mainly coming from North America and Western European countries. Further data to inform on the real-world effectiveness of immunotherapy worldwide are needed.
Keywords: non-small cell lung carcinoma, immunotherapy, advanced non-small cell lung cancer, real-world data, Central Europe, Europe, Eastern Europe
Published in DiRROS: 12.10.2021; Views: 904; Downloads: 277
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NSCLC molecular testing in Central and Eastern European countries
Ales Ryška, Peter Berzinec, Luka Brčić, Tanja Čufer, Rafal Dziadziuszko, Maya Gottfried, Ilona Kovalszky, Włodzimierz Olszewski, Buge Oz, Lukas Plank, József Tímár, 2018, original scientific article

Abstract: Background: The introduction of targeted treatments for subsets of non-small cell lung cancer (NSCLC) has highlighted the importance of accurate molecular diagnosis to determine if an actionable genetic alteration is present. Few data are available for Central and Eastern Europe (CEE) on mutation rates, testing rates, and compliance with testing guidelines. Methods: A questionnaire about molecular testing and NSCLC management was distributed to relevant specialists in nine CEE countries, and pathologists were asked to provide the results of EGFR and ALK testing over a 1-year period. Results: A very high proportion of lung cancer cases are confirmed histologically/cytologically (75-100%), and molecular testing of NSCLC samples has been established in all evaluated CEE countries in 2014. Most countries follow national or international guidelines on which patients to test for EGFR mutations and ALK rearrangements. In most centers at that time, testing was undertaken on request of the clinician rather than on the preferred reflex basis. Immunohistochemistry, followed by fluorescent in situ hybridization confirmation of positive cases, has been widely adopted for ALK testing in the region. Limited reimbursement is a significant barrier to molecular testing in the region and a disincentive to reflex testing. Multidisciplinary tumor boards are established in most of the countries and centers, with 75-100% of cases being discussed at a multidisciplinary tumor board at specialized centers. Conclusions: Molecular testing is established throughout the CEE region, but improved and unbiased reimbursement remains a major challenge for the future. Increasing the number of patients reviewed by multidisciplinary boards outside of major centers and access to targeted therapy based on the result of molecular testing are other major challenges.
Keywords: non-small-cell lung carcinoma, molecular diagnostic techniques, EGFR mutations, ALK rearrangements, Central Europe, Eastern Europe
Published in DiRROS: 30.11.2020; Views: 1542; Downloads: 888
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16.
Achieving thoracic oncology data collection in Europe : a precursor study in 35 countries
Anna Rich, David R. Baldwin, Inmaculada Alfageme, Paul Beckett, Thierry Berghmans, Stephen Brincat, Otto Burghuber, Alexandru Corlateanu, Tanja Čufer, Ronald Damhuis, 2018, original scientific article

Abstract: Background: A minority of European countries have participated in international comparisons with high level data on lung cancer. However, the nature and extent of data collection across the continent is simply unknown, and without accurate data collection it is not possible to compare practice and set benchmarks to which lung cancer services can aspire. Methods: Using an established network of lung cancer specialists in 37 European countries, a survey was distributed in December 2014. The results relate to current practice in each country at the time, early 2015. The results were compiled and then verified with co-authors over the following months. Results: Thirty-five completed surveys were received which describe a range of current practice for lung cancer data collection. Thirty countries have data collection at the national level, but this is not so in Albania, Bosnia- Herzegovina, Italy, Spain and Switzerland. Data collection varied from paper records with no survival analysis, to well-established electronic databases with links to census data and survival analyses. Conclusion: Using a network of committed clinicians, we have gathered validated comparative data reporting an observed difference in data collection mechanisms across Europe. We have identified the need to develop a welldesigned dataset, whilst acknowledging what is feasible within each country, and aspiring to collect high quality data for clinical research.
Keywords: lung neoplasms -- epidemiology -- Europe, lung cancer, studies
Published in DiRROS: 12.11.2020; Views: 1160; Downloads: 541
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17.
Non-small cell lung cancer in countries of Central and Southeastern Europe : diagnostic procedures and treatment reimbursement surveyed by the Central European Cooperative Oncology Group
Ales Ryška, Rares Buiga, Albena Fakirova, Izidor Kern, Włodzimierz Olszewski, Lukas Plank, Sven Seiwerth, Erika Toth, Eri Zivka, Christiane Thallinger, Christoph Zielinski, Luka Brčić, 2018, original scientific article

Abstract: This article analyzes the availability of different diagnostic procedures of non-small cell lung cancer (NSCLC) and the reimbursement landscape of drugs for NSCLC in countries of central and southeastern Europe (CEE). A survey was conducted by the Central European Cooperative Oncology Group. Results of the survey show that both availability and reimbursement of diagnoses of molecular alterations in NSCLC, the detection of which is essential for therapeutic decisions, varies widely between countries of CEE. Not only is "reflex" testing often substituted by analyses performed only "on demand," but reimbursement of such assessments varies widely between unavailability and payments by the health care system or even pharmaceutical companies. It was concluded that a structured access to testing and reimbursement should be the aim in order to provide patients with appropriate therapeutic options. Implications for Practice. This article provides an overview of the limitations in lung cancer treatment in countries of central and southeastern Europe, as well as the reimbursement status of various lung cancer treatment regimens in these countries, which directly impacts treatment options.
Keywords: Non-small cell lung carcinoma -- diagnosis -- economics -- Europe, molecular diagnostic techniques, precision medicine, Central Europe, Southeastern Europe, reimbursement
Published in DiRROS: 09.11.2020; Views: 1429; Downloads: 333
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18.
Expenditures on oncology drugs and cancer mortality-to-incidence ratio in Central and Eastern Europe
Eduard Vrdoljak, Gyorgy Bodoky, Jacek Jassem, Razvan A. Popescu, Robert Pirker, Tanja Čufer, Semir Beslija, Alexsandru Eniu, Vladimir Todorović, Katerina Kopečková, 2019, original scientific article

Abstract: Background. There is a steady decline in cancer mortality in Western Europe (WE), but this trend is not so obvious in Central and Eastern Europe (CEE). One of the largest discrepancies between WE and CEE is the level of investment in cancer care. The objective of our analysis was to examine the correlation between mortality-to-incidence (M/I) ratio and expenditures on oncology drugs in CEE and WE. Materials and Methods. This cross-sectional analysis was done on publicly available data. Data on expenditures for oncology drugs were obtained from QuintilesIMS, and data on M/I ratio from Globocan. The main outcome was mortality-to-incidence ratio, and the primary analysis was performed by Spearman's rank correlation. Results. There is a large discrepancy in expenditure on oncology drugs per cancer case between WE and CEE, and within CEE. Average expenditure on oncology drugs per capita as well as per new cancer case was 2.5 times higher in WE than in CEE. Availability of oncology drugs was highest in Germany (100%), relatively similar in WE (average of 91%), but in CEE it ranged from 37% to 86%, with an average of 70%. Annual expenditures on all oncology drugs per new cancer case was significantly negatively correlated with the M/I ratio (Spearman's p = -0.90, p < .001). Conclusion. There is a financial threshold for oncology drugs per cancer case needed to increase survival. Based on significantly lower expenditures for oncology drugs in CEE in comparison with WE, more investment for drugs as well as better, more organized,value-oriented consumption is needed. Implications for Practice. Cancer is not treated equally successfully in Western Europe (WE) and in Central and Eastern Europe (CEE). This study showed that success in treatment of cancer is associated with the amount of money invested in oncology drugs. CEE countries spend on average 2.5 times less than WE countries for oncology drugs per new cancer case. These findings should be used by healthcare providers and oncologists struggling for more resources and better, more organized, evidence-based allocation of these resources as well as better oncology outcomes.
Keywords: neoplasms -- mortality -- epidemiology, incidence, pharmaceutical preparations -- economics, cancer, oncology, Central Europe, Eastern Europe, drug expenditures
Published in DiRROS: 26.10.2020; Views: 1288; Downloads: 290
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19.
Lung cancer biomarker testing : perspective from Europe
Erik Thunnissen, Birgit Weynand, Dalma Udovicic-Gagula, Luka Brčić, Malgorzata Szolkowska, Paul Hofman, Silvana Smojver-Ježek, Sisko Anttila, Fiorella Calabrese, Izidor Kern, 2020, review article

Abstract: A questionnaire on biomarker testing previously used in central European countries was extended and distributed in Western and Central European countries to the pathologists participating at the Pulmonary Pathology Society meeting 26-28 June 2019 in Dubrovnik, Croatia. Each country was represented by one responder. For recent biomarkers the availability and reimbursement of diagnoses of molecular alterations in non-small cell lung carcinoma varies widely between different, also western European, countries. Reimbursement of such assessments varies widely between unavailability and payments by the health care system or even pharmaceutical companies. The support for testing from alternative sources, such as the pharmaceutical industry, is no doubt partly compensating for the lack of public health system support, but it is not a viable or long-term solution. Ideally, a structured access to testing and reimbursement should be the aim in order to provide patients with appropriate therapeutic options. As biomarker enabled therapies deliver a 50% better probability of outcome success, improved and unbiased reimbursement remains a major challenge for the future.
Keywords: lung neoplasms -- diagnosis -- therapy -- Europe, lung cancer, predictive testing
Published in DiRROS: 21.09.2020; Views: 1574; Downloads: 1032
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20.
Access to novel drugs for non-small cell lung cancer in Central and Southeastern Europe : a Central European Cooperative Oncology Group analysis
Tanja Čufer, Tudor Ciuleanu, Peter Berzinec, Gabriela Galffy, Marko Jakopović, Jacek Jassem, Dragana Jovanovic, Zhasmina MIhaylova, Gyula Ostoros, Christiane Thallinger, Milada Zemanova, Christoph Zielinski, 2020, original scientific article

Abstract: Background. Treatment of non-small cell lung cancer (NSCLC) improved substantially in the last decades. Novel targeted and immune-oncologic drugs were introduced into routine treatment. Despite accelerated development and subsequent drug registrations by the European Medicinal Agency (EMA), novel drugs for NSCLC are poorly accessible in Central and Eastern European (CEE) countries. Material and Methods. The Central European Cooperative Oncology Group conducted a survey among experts from 10 CEE countries to provide an overview on the availability of novel drugs for NSCLC and time from registration to reimbursement decision in their countries. Results. Although first-generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries, for other registered therapies - even for ALK inhibitors and checkpoint inhibitors in first-line - there were apparent gaps in availability and/or reimbursement. There was a trend for better availability of drugs with longer time from EMA marketing authorization. Substantial differences in access to novel drugs among CEE countries were observed. In general, the availability of drugs is not in accordance with the Magnitude of Clinical Benefit Scale (MCBS), as defined by the European Society for Medical Oncology (ESMO). Time spans between drug registrations and national decisions on reimbursement vary greatly, from less than 3 months in one country to more than 1 year in the majority of countries. Conclusion. The access to novel drugs for NSCLC in CEE countries is suboptimal. To enable access to the most effective compounds within the shortest possible time, reimbursement decisions should be faster and ESMO MCBS should be incorporated into decision making.
Keywords: non-small cell lung cancer, treatment, novel drugs, Central Europe, Southeastern Europe
Published in DiRROS: 24.07.2020; Views: 1791; Downloads: 1052
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