11. Real-world testing practices, treatment patterns and clinical outcomes in patients from Central Eastern Europe with EGFR-mutated advanced non-small cell lung cancer : a retrospective chart review study (REFLECT)Urška Janžič, Nina Turnšek, Mircea Dediu, Ivan Shterev Donev, Roxana Lupu, Gabriela Teodorescu, Tudor Ciuleanu, Adam Płużański, 2022, original scientific article Abstract: The targeted therapy with tyrosine kinase inhibitors (TKIs) against the epidermal growth factor receptor mutation (EGFRm) in advanced non-small cell lung cancer (NSCLC) changed the treatment paradigm. REFLECT study (NCT04031898) explored EGFR/T790M testing and treatment patterns in EGFRm NSCLC patients receiving first- or second-generation (1G/2G) EGFR TKIs as front-line (1L) in eight countries. Pooled data from Central Eastern Europe (CEE) countries from this study (Bulgaria, Poland, Romania, Slovenia) are presented here. This physician-led chart review study was conducted in patients with confirmed-EGFRm NSCLC initiating 1L 1G/2G EGFR TKIs between 2015–2018. The CEE cohort included 389 patients receiving 1L erlotinib (37%), afatinib (34%), and gefitinib (29%). Overall, 320 (82%) patients discontinued 1L, and 298 (77%) progression events were registered. Median progression free survival on 1L TKIs was 14.0 (95% CI: 12.6–15.6) months. Median overall survival from 1L start was 26.6 (95% CI: 24.1–29.0) months. Attrition rate between 1L and next line was 30%. Among patients with 1L progression, 200 (67%) were tested for T790M and 58% were positive. This first CEE analysis of treatments and outcomes in EGFRm NSCLC patients highlights the importance of using the most efficacious therapies currently available in 1L to reduce attrition and improve patient outcomes.
Keywords: lung neoplasms, non-small cell lung carcinoma, Eastern Europe, real-world study, REFLECT study, epidermal growth factor receptor, lung cancer
Published in DiRROS: 09.09.2022; Views: 722; Downloads: 298
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12. Availability and costs of medicines for the treatment of tuberculosis in EuropeGunar Günther, Lorenzo Guglielmetti, Claude Leu, Christoph Lange, Frank van Leth, 2022, review article Abstract: Objectives. To evaluate the access to comprehensive diagnostics and novel anti-tuberculosis medicines in European countries. Methods. We investigated access to genotypic and phenotypic M. tuberculosis drug susceptibility testing, availability of anti-tuberculosis drugs and calculated cost of drugs and treatment regimens at major tuberculosis treatment centers in countries of the World Health Organization (WHO) European region where rates of drug-resistant tuberculosis are highest among all WHO regions. Results are stratified by middle-income and high-income countries. Results. Overall, 43 treatment centers in 43 countries participated in the study. For WHO Group A drugs, the frequency of countries with availability of phenotypic drug susceptibility testing was as follows: 30/40 (75%) for levofloxacin, 33/40 (82%) for moxifloxacin, 19/40 (48%) for bedaquiline and 29/40 (72%) for linezolid, respectively. Overall, 36/43 (84%) and 24/43 (56%) of countries had access to bedaquiline and delamanid, while only 6/43 (14%) had access to rifapentine. Treatment of patients with extensively drug-resistant tuberculosis with a regimen including a carbapenem was only available in 17/43 (40%) of the countries. Median cost of regimens for drug-susceptible tuberculosis, multidrug-resistant/rifampicin-resistant tuberculosis (shorter regimen, including bedaquiline for six months) and extensively drug-resistant tuberculosis (including bedaquiline, delamanid and a carbapenem) were € 44 (min-max € 15-152), € 764 (min-max € 542-15152) and € 8709 (min-max € 7965-11759) in middle-income countries (n=12), and € 280 (min-max-€78-1084), € 29765 (min-max 11116-40584), € 217591 (min-max € 82827-320146) in high-income countries (n=29). Conclusion. In countries of the WHO Europe Region there is a widespread lack of drug susceptibility testing capacity to new and re-purposed anti-tuberculosis drugs, lack of access to essential medications in several countries and high treatment cost for drug-resistant tuberculosis.
Keywords: tuberculosis - drug therapy, Mycobacterium tuberculosis - drug therapy, health care costs - drug therapy, Europe
Published in DiRROS: 31.08.2022; Views: 926; Downloads: 228
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13. Terminologies and characteristics of natural mineral and thermal waters in selected European countriesDaniel Elster, Teodóra Szőcs, Nóra Gál, Birgitte Hansen, Denitza D. Voutchkova, Jörg Schullehner, Julie Lions, Lucio Martarelli, Elena Giménez-Forcada, José Angel Díaz-Muñoz, Eline Malcuit, Gerhard Schubert, Gerhard Hobiger, Nina Rman, 2022, review article Abstract: This study discusses 1) the national legislative frameworks, terminologies, and criteria for the recognition of natural mineral waters and thermal waters in selected European countries (Austria, Bosnia and Herzegovina, Denmark, France, Hungary, Iceland, Italy, Lithuania, Poland, Portugal, Romania, Serbia, Slovenia, and Spain), and 2) it provides a first extensive multi-national overview of hydrogeological and hydrogeochemical characteristics of numerous water sources from those regions.
Keywords: hydrogeology, regulatory framework, hydrogeochemical composition, natural mineral water, thermal water, Europe
Published in DiRROS: 26.07.2022; Views: 922; Downloads: 310
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14. Results of screening in early and advanced thoracic malignancies in the EORTC pan-European SPECTAlung platformMarie Morfouace, Silvia Novello, A. Stevovic, C. Dooms, Urška Janžič, Thierry Berghmans, Rafal Dziadziuszko, T. Gorlia, Enriqueta Felip, Benjamin Besse, 2022, original scientific article Abstract: Access to a comprehensive molecular alteration screening is patchy in Europe and quality of the molecular analysis varies. SPECTAlung was created in 2015 as a pan-European screening platform for patients with thoracic malignancies. Here we report the results of almost 4 years of prospective molecular screening of patients with thoracic malignancies, in terms of quality of the program and molecular alterations identified. Patients with thoracic malignancies at any stage of disease were recruited in SPECTAlung, from June 2015 to May 2019, in 7 different countries. Molecular tumour boards were organised monthly to discuss patients' molecular and clinical profile and possible biomarker-driven treatments, including clinical trial options. FFPE material was collected and analysed for 576 patients with diagnosis of pleural, lung, or thymic malignancies. Ultimately, 539 patients were eligible (93.6%) and 528 patients were assessable (91.7%). The turn-around time for report generation and molecular tumour board was 214 days (median). Targetable molecular alterations were observed in almost 20% of cases, but treatment adaptation was low (3% of patients). SPECTAlung showed the feasibility of a pan-European screening platform. One fifth of the patients had a targetable molecular alteration. Some operational issues were discovered and adapted to improve efficiency.
Keywords: thoracic neoplasms -- Europe, lung neoplasms -- Europe, diagnostic screening programs -- Europe, malignancies, lung cancer
Published in DiRROS: 24.06.2022; Views: 907; Downloads: 609
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15. New records and noteworthy data of plants, algae and fungi in SE Europe and adjacent regions, 8Gordana Tomović, Marko S. Sabovljević, Marjan Niketić, Petya Boycheva, Predrag Lazarević, Eva Kabaš, Danijela Vidaković, Jelena Krizmanić, Lado Kutnar, Janez Kermavnar, Milorad Veljković, Vladan Djordjević, Boris Assyov, Fuat Bozok, Simona Strgulc-Krajšek, Žan Lobnik Cimerman, Sorin Stefanut, Constantin-Ciprian Bîrsan, Alma Hajrudinović-Bogunić, Ante Begić, 2022, original scientific article Abstract: This paper presents new records and noteworthy data on the following taxa in SE Europe and adjacent regions: diatom alga Cylindrotheca gracilis, fungi Laccaria macrocystidiata, liverworts Riccia canaliculata, Riccia cavernosa, and Riccia frostii, mosses Dicranum viride, monocots Arundo donax, Cephalanthera rubra, Epipactis palustris, and Sternbergia colchiciflora and dicots Aconitum anthora and Cephalaria pastricensis are given within SE Europe and adjacent regions.
Keywords: new report, Aconitum anthora, Arundo donax, Cephalanthera rubra, Cephalaria pastricensis, Cylindrotheca gracilis, Dicranum viride, Epipactis palustris, Laccaria macrocystidiata, Riccia canaliculata, Riccia cavernosa, Riccia frostii, Sternbergia colchiciflora, SE Europe
Published in DiRROS: 20.04.2022; Views: 781; Downloads: 548
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16. New records and noteworthy data of plants, algae and fungi in SE Europe and adjacent regions, 7Marko S. Sabovljević, Gordana Tomović, Predrag Lazarević, Maja Lazarević, Snežana Vukojičić, Snežana Vukojičić, Ivana Trbojević, Jovana Pantović, Simona Strgulc-Krajšek, Darja Kopitar, Uroš Buzurović, Sanja Z. Djurović, Lado Kutnar, Janez Kermavnar, Zbigniew Szeląg, Petya Boycheva, Dobri Ivanov, Milorad Veljković, Vladan Djordjević, Sorin Stefanut, Constantin-Ciprian Bîrsan, 2022, original scientific article Abstract: his paper presents new records and noteworthy data on the following taxa in SE Europe and adjacent regions: stonewort Chara intermedia, liverworts Fossombronia wondraczekii and Pseudomoerckia blyttii, mosses Hamatocaulis vernicosus and Hookeria lucens, monocots Gladiolus palustris, Neotinea tridentata, and Orchis militaris and dicots Cardamine serbica, Cardamine waldsteinii, Hieracium kotschyanum and Pilosella petraea are given within SE Europe and adjacent regions.
Keywords: new report, Cardamine serbica, Cardamine waldsteinii, Chara intermedia, Gladiolus palustris, Fossombronia wondraczekii, Hamatocaulis vernicosus, Hieracium kotschyanum, Hookeria lucens, Neotinea tridentata, Orchis militaris, Pilosella petraea, Pseudomoerckia blyttii, SE Europe
Published in DiRROS: 20.04.2022; Views: 726; Downloads: 538
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17. 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: 1031; Downloads: 502
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18. Corythucha arcuata (Say, 1832) (Hemiptera, Tingidae) in its invasive range in Europe : perception, knowledge and willingness to act in foresters and citizensFlavius 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: 1406; Downloads: 855
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19. Immunotherapy for metastatic non-small cell lung cancer : real-world data from an academic Central and Eastern European centerMarija 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: 1159; Downloads: 364
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