Spatial distribution of bivalves in relation to environmental conditions (middle Danube catchment, Hungary)

The spatial distribution of bivalves in relation to environmental conditions was studied along a second- and third order stream – medium-sized river (River Ipoly) – large river (River Danube) continuum in the Hungarian Danube River system. Quantitative samples were collected four times in 2007 and a total of 1662 specimens, belonging to 22 bivalve species were identified. Among these species, two are endangered (Pseudanodonta complanata, Unio crassus) and five are invasive (Dreissena polymorpha, D. rostriformis bugensis, Corbicula fluminea, C. fluminalis, Anodonta woodiana) in Hungary. The higher density presented by Pisidium subtruncatum, P. supinum, P. henslowanum and C. fluminea suggests that these species may have a key role in this ecosystem. Three different faunal groups were distinguished but no significant temporal change was detected. The lowest density and diversity with two species (P. casertanum and P. personatum) occurred in streams. The highest density and diversity was found in the River Ipoly, in the side arms of the Danube and in the main arm of the Danube with sand and silt substrate, being dominated by P. subtruncatum and P. henslowanum. Moderate density and species richness were observed in the main arm of the Danube with pebble and stone substrate, being dominated by C. fluminea and S. rivicola. Ten environmental variables were found to have significant influence on the distribution of bivalves, the strongest explanatory factors being substrate types, current velocity and sedimentological characteristics.The project was financially supported by the Hungarian Scientific Research Fund under the contract No. OTKA T/046180. Special thanks to the DanubeIpoly National Park for the help in field work.info:eu-repo/semantics/publishedVersio

The path to a better biomarker: Application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice

Immune checkpoint inhibitor therapies targeting PD-1/PD-L1 are now the standard of care in oncology across several hematologic and solid tumor types, including triple negative breast cancer (TNBC). Patients with metastatic or locally advanced TNBC with PD-L1 expression on immune cells occupying 651% of tumor area demonstrated survival benefit with the addition of atezolizumab to nab-paclitaxel. However, concerns regarding variability between immunohistochemical PD-L1 assay performance and inter-reader reproducibility have been raised. High tumor-infiltrating lymphocytes (TILs) have also been associated with response to PD-1/PD-L1 inhibitors in patients with breast cancer (BC). TILs can be easily assessed on hematoxylin and eosin\u2013stained slides and have shown reliable inter-reader reproducibility. As an established prognostic factor in early stage TNBC, TILs are soon anticipated to be reported in daily practice in many pathology laboratories worldwide. Because TILs and PD-L1 are parts of an immunological spectrum in BC, we propose the systematic implementation of combined PD-L1 and TIL analyses as a more comprehensive immuno-oncological biomarker for patient selection for PD-1/PD-L1 inhibition-based therapy in patients with BC. Although practical and regulatory considerations differ by jurisdiction, the pathology community has the responsibility to patients to implement assays that lead to optimal patient selection. We propose herewith a risk-management framework that may help mitigate the risks of suboptimal patient selection for immuno-therapeutic approaches in clinical trials and daily practice based on combined TILs/PD-L1 assessment in BC. \ua9 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd

Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials.

Funder: Breast Cancer Research Foundation (BCRF); doi: https://doi.org/10.13039/100001006Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting

Use of SMS texts for facilitating access to online alcohol interventions: a feasibility study

A41 Use of SMS texts for facilitating access to online alcohol interventions: a feasibility study In: Addiction Science & Clinical Practice 2017, 12(Suppl 1): A4

Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting