41. Multicenter evaluation of the fully automated PCR-based Idylla EGFR Mutation Assay on formalin-fixed, paraffin-embedded Q1 tissue of human lung cancerSolène M. Evrard, Estelle T. Clermont, Isabelle Rouquette, Samuel Murray, Sebastian Dintner, Yun-Chung Nam-Apostolopoulos, Beatriz Bellosillo, Mar V. Rodriguez, Ernest Nadal, Klaus H. Wiedorn, Mitja Rot, Izidor Kern, 2019, original scientific article Abstract: Before initiating treatment of advanced nonesmall-cell lung cancer with tyrosine kinase inhibitors (eg, erlotinib, gefitinib, osimertinib, and afatinib), which inhibit the catalytic activity of epidermal growth factor receptor (EGFR), clinical guidelines require determining the EGFR mutational status for activating (EGFR exons 18, 19, 20, or 21) and resistance (EGFR exon 20) mutations. The EGFR resistance mutation T790M should be monitored at cancer progression. The Idylla EGFR Mutation Assay, performed on the Idylla molecular diagnostics platform, is a fully automated (<2.5 hours turnaround time) sample-to-result molecular test to qualitatively detect 51 EGFR oncogene point mutations, deletions, or insertions. In a 15- center evaluation, Idylla results on 449 archived formalin-fixed, paraffin-embedded tissue sections, originating from nonesmall-cell lung cancer biopsies and resection specimens, were compared with data obtained earlier with routine reference methods, including next-generation sequencing, Sanger sequencing, pyrosequencing, mass spectrometry, and PCR-based assays. When results were discordant, a third method of analysis was performed, when possible, to confirm test results. After confirmation testing and excluding invalids/errors and discordant results by design, a concordance of 97.6% was obtained between Idylla and routine test results. Even with <10 mm2 of tissue area, a valid Idylla result was obtained in 98.9% of the cases. The Idylla EGFR Mutation Assay enables sensitive detection of most relevant EGFR mutations in concordance with current guidelines, with minimal molecular expertise or infrastructure.
Keywords: non-small cell lung carconima -- diagnosis -- genetics, ErbB receptors, sequence analysis, tyrosine kinase inhibitors, epidermal growth factor receptor
Published in DiRROS: 07.10.2020; Views: 1454; Downloads: 1022
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42. Position of an international panel of lung cancer experts on the decision for expansion of approval for pembrolizumab in advanced non-small-cell lung cancer with a PD-L1 expression level of >= 1 by the USA Food and Drug AdministrationGiannis Mountzios, J. Remon, Silvia Novello, N. Blais, R. Califano, Tanja Čufer, Anne-Marie C. Dingemans, S. V. Liu, N. Peled, N. A. Pennell, 2019, other scientific articles Keywords: non-small cell lung carcinoma, drug therapy, KEYNOTE-024 trial, pemrolizumab, treatment
Published in DiRROS: 21.09.2020; Views: 1331; Downloads: 871
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43. Lung cancer biomarker testing : perspective from EuropeErik 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: 1715; Downloads: 1081
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44. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer : updated analysis of the observational GioTag studyMaximilian J Hochmair, Alessandro Morabito, Desiree Hao, Cheng-Ta Yang, Ross A Soo, James C-H Yang, Rasim Gucalp, Balazs Halmos, Lara Wang, Angela Märten, Tanja Čufer, 2019, original scientific article Abstract: Aims: Overall survival (OS) and updated time to treatment failure (TTF) analysis of patients with EGFR mutation-positive (Del19, L858R) non-small-cell lung cancer who received sequential afatinib/osimertinib in the real-world GioTag study. Patients & methods: Patients had T790M-positive disease following first-line afatinib and received osimertinib treatment (n = 203). Primary outcome was TTF. The OS analysis was exploratory. Results: Median OS was 41.3 months (90% CI: 36.8-46.3) overall and 45.7 months (90% CI: 45.3-51.5) in patients with Del19-positive tumors (n = 149); 2-year survival was 80 and 82%, respectively. Updated median TTF with afatinib and osimertinib was 28.1 months (90% CI: 26.8-30.3). Conclusion: Sequential afatinib/osimertinib was associated with encouraging OS/TTF in patients with EGFR T790M-positive non-small-cell lung cancer, especially in patients with Del19-positive tumors.
Keywords: non-small cell lung carcinoma - therapy, drug therapy, afatinib, osimertinib, GioTag study
Published in DiRROS: 11.09.2020; Views: 1480; Downloads: 1071
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45. Pulmonary pathology and COVID-19 : lessons from autopsy : the experience of European pulmonary pathologistsFiorella Calabrese, Federica Pezzuto, Francesco Fortarezza, Paul Hofman, Izidor Kern, Angel Panizo, Jan von der Thüsen, Sergei Timofeev, Gregor Gorkiewicz, Francesca Lunardi, 2020, original scientific article Abstract: Since its initial recognition in December 2019, Coronavirus disease 19 (COVID-19) has quickly spread to a pandemic
infectious disease. The causative agent has been recognized as a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), primarily affecting the respiratory tract. To date, no vaccines are available nor any specific treatment. To limit the number of infections, strict directives have been issued by governments that have been translated into equally rigorous guidelines notably for post-mortem examinations by international and national scientific societies. The recommendations for biosafety control required during specimen collection and handling have strongly limited the practice of autopsies of the COVID-19 patients to a few adequate laboratories. A full pathological examination has always been considered an important tool to better understand the pathophysiology of diseases, especially when the knowledge of an emerging disorder is limited and the impact on the healthcare system is significant. The first evidence of diffuse alveolar damage in the context of an acute respiratory distress syndrome has now been joined by the latest findings that report a more complex scenario in COVID-19, including a vascular involvement and a wide spectrum of associated pathologies. Ancillary tools such as electron microscopy and molecular biology used on autoptic tissue samples from autopsy are also significantly contributing to confirm and/or identify new aspects useful for a deeper knowledge of the pathogenetic mechanisms. This article will review and summarize the pathological findings described in COVID-19 until now, chiefly focusing on the respiratory tract, highlighting the importance of autopsy towards a better knowledge of this disease.
Keywords: COVID-19, SARS-CoV-2, autopsy, lung, pandemic
Published in DiRROS: 31.07.2020; Views: 13466; Downloads: 1171
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46. Coping strategies of patients with advanced lung or colorectal cancer in six European countries : insights from the ACTION studyLea J. Jabbarian, Ida Joanna Korfage, Branka Červ, Johannes JM van Delden, Luc Deliens, Guido Miccinesi, Sheila Payne, Anna Thit Johnsen, Mariette Verkissen, Andrew Wilcock, Agnes van der Heide, Judith Anna Catharina Rietjens, 2020, review article Abstract: Objective: Even when medical treatments are limited, supporting patients' coping strategies could improve their quality of life. Greater understanding of patients' coping strategies, and influencing factors, can aid developing such support. We examined the prevalence of coping strategies and associated variables. Methods: We used sociodemographic and baseline data from the ACTION trial, including measures of Denial, Acceptance and Problem-focused coping (COPE; Brief COPE inventory), of patients with advanced cancer from six European countries. Clinicians provided clinical information. Linear mixed models with clustering at hospital level were used. Results: Data from 675 patients with stage III/ IV lung (342, 51%) or stage IV colorectal (333, 49%) cancer were used; mean age 66 (10 SD) years. Overall, patients scored low on Denial and high on Acceptance and Problem-focused coping. Older age was associated with higher scores on Denial than younger age ([beta] = 0.05; CI[0.023; 0.074]), and patients from Italy ([beta] = 1.57 CI[0.760; 2.388]) and Denmark ([beta] = 1.82 CI[0.881; 2.750]) scored higher on Denial than patients in other countries. Conclusions: Patients with advanced cancer predominantly used Acceptance and Problem-focused coping, and Denial to a lesser extent. Since the studied coping strategies of patients with advanced cancer vary between subpopulations, we recommend taking these factors into account when developing tailored interventions to support patients' coping strategies.
Keywords: ACTION study, lung cancer, colorectal cancer, coping strategies
Published in DiRROS: 29.07.2020; Views: 1759; Downloads: 1168
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48. Access to novel drugs for non-small cell lung cancer in Central and Southeastern Europe : a Central European Cooperative Oncology Group analysisTanja 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: 1931; Downloads: 1117
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