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

TOI-1431b/MASCARA-5b: a highly irradiated ultrahot Jupiter orbiting one of the hottest and brightest known exoplanet host stars

Stars and planetary system

Behavioural, emotional and family functioning of hospitalized children in China and Hong Kong

Purpose: This study examined behavioural and emotional problems, social competence and family functioning of hospitalized Chinese children in Hong Kong and the Chinese Mainland. Method: A sample of 210 hospitalized children (ages 2-11 years) and their families participated in the study. The families were from a cross-section of geographical areas in Hong Kong (two hospitals) and the Chinese Mainland (five hospitals). Parents completed an age-appropriate Chinese version of the Child Behaviour Checklist and the Family Assessment Device. Multiple regression models were used to examine predictors of children's behaviour problems. Results: Behavioural patterns appeared to be specific to the developmental stage. Children had greater problems when their families demonstrated poorer affective involvement. Hospitalized children on the Chinese Mainland experienced more internalizing and externalizing behaviour problems than those in Hong Kong. Sick children, according to their parents, however, demonstrate some resiliency based on social and academic competency factors. Conclusions: Hospitalized Chinese children manifest behavioural, emotional and family problems that vary by region, the child's development and gender. Problems predominantly of an internalizing nature characterized this group. The findings support the need for culturally appropriate behavioural assessments and interventions with hospitalized children.School of Nursin