Clinical trial inclusion in patients with relapsed/refractory neuroblastoma following the European Precision Cancer Medicine trial MAPPYACTS.

INTRODUCTION: Despite poor survival for patients with relapsed or refractory neuroblastoma, only 10-16% of patients are reported to be included in early phase trials. This study aimed to explore the impact of molecular profiling within the prospective precision cancer medicine trial MAPPYACTS (NCT02613962) on subsequent early phase trial recruitment and treatment by matched targeted therapies in this population. METHODS AND MATERIALS: Clinical data from all French patients with relapsed/refractory neuroblastoma enrolled in MAPPYACTS were analyzed for subsequent matched/non-matched targeted treatment based on clinical tumor board (CMTB) recommendations. RESULTS: From 93 patients with neuroblastoma included in French centers, 78 (84%) underwent whole exome and RNA sequencing and were discussed in the CMTB. Higher rate of successful sequencing analysis was observed in patients with relapsed disease compared to those with refractory disease (p = 0.0002). Among the 50 patients that presented with a new disease relapse/progression after the CMTB recommendations, 35 patients (70%) had at least one actionable alteration identified on the tumor at the time of relapse. Eighteen patients (36%) were included in an early phase clinical trial, 11 of these with a matched agent, 7 with a non-matched treatment; 13 patients were included in the AcSé ESMART trial. Five patients (10%) received a matched targeted therapy outside a clinical trial. CONCLUSION: Patients with neuroblastoma in the European MAPPYACTS trial were more likely to be included in early phase trials compared to previous reports. Early deep sequencing at first treatment failure, comprehensive therapeutic discussions in molecular tumor boards and innovative trials like AcSé -ESMART improve access to innovative therapies for patients with relapsed/refractory neuroblastoma. CLINICAL TRIAL REGISTRATION: NCT02613962.

Team Emergency Assessment Measure (TEAM) for the assessment of non-technical skills during resuscitation: Validation of the French version.

AIM: Evaluation of team performances during medical simulation must rely on validated and reproducible tools. Our aim was to build and validate a French version of the Team Emergency Assessment Measure (TEAM) score, which was developed for the assessment of team performance and non-technical skills during resuscitation. METHODS: A forward and backward translation of the initial TEAM score was made, with the agreement and the final validation by the original author. Ten medical teams were recruited and performed a standardized cardiac arrest simulation scenario. Teams were videotaped and nine raters evaluate non-technical skills for each team thanks to the French TEAM Score. Psychometric properties of the score were then evaluated. RESULTS: French TEAM score showed an excellent reliability with a Cronbach coefficient of 0.95. Mean correlation coefficient between each item and the global score range was 0.78. The inter-rater reliability measured by intraclass correlation coefficient of the global score was 0.93. Finally, expert teams had higher French TEAM score than intermediate and novice teams. CONCLUSION: The French TEAM score shows good psychometric properties to evaluate team performance during cardiac arrest simulation. Its utilization could help in the assessment of non-technical skills during simulation.