Prognostic 18F-FDG Radiomic Features in Advanced High-Grade Serous Ovarian Cancer.

High-grade serous ovarian cancer (HGSOC) is an aggressive disease with different clinical outcomes and poor prognosis. This could be due to tumor heterogeneity. The 18F-FDG PET radiomic parameters permit addressing tumor heterogeneity. Nevertheless, this has been not well studied in ovarian cancer. The aim of our work was to assess the prognostic value of pretreatment 18F-FDG PET radiomic features in patients with HGSOC. A review of 36 patients diagnosed with advanced HGSOC between 2016 and 2020 in our center was performed. Radiomic features were obtained from pretreatment 18F-FDGPET. Disease-free survival (DFS) and overall survival (OS) were calculated. Optimal cutoff values with receiver operating characteristic curve/median values were used. A correlation between radiomic features and DFS/OS was made. The mean DFS was 19.6 months and OS was 37.1 months. Total Lesion Glycolysis (TLG), GLSZM_ Zone Size Non-Uniformity (GLSZM_ZSNU), and GLRLM_Run Length Non-Uniformity (GLRLM_RLNU) were significantly associated with DFS. The survival-curves analysis showed a significant difference of DSF in patients with GLRLM_RLNU > 7388.3 versus patients with lower values (19.7 months vs. 31.7 months, p = 0.035), maintaining signification in the multivariate analysis (p = 0.048). Moreover, Intensity-based Kurtosis was associated with OS (p = 0.027). Pretreatment 18F-FDG PET radiomic features GLRLM_RLNU, GLSZM_ZSNU, and Kurtosis may have prognostic value in patients with advanced HGSOC.

The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions.

INTRODUCTION AND OBJECTIVE: European Union legislation has mandated the submission of European Economic Area non-serious reports to the EudraVigilance database since November 2017. As spontaneous reports of suspected adverse reactions to medicines represent a key source of safety signals, the European Medicines Agency has undertaken this work to assess the effects of this requirement on the characteristics of the reports submitted to EudraVigilance and on the detection of adverse drug reactions through routine analyses of the database. METHODS: Changes in the numbers of serious and non-serious reports transmitted to EudraVigilance were examined over the period during which the legislation was implemented. The numbers and nature of potential safety signals emerging from established statistical algorithms used at the European Medicines Agency applied either to only the serious reports or to all reports in EudraVigilance were compared. RESULTS: Up to November 2017, less than 25% of European Economic Area reports in EudraVigilance were classified as non-serious, since than this figure was slightly above 60%. This change accompanied an increase in the total number of reports received. Addition of non-serious reports to the signal detection process resulted in a small overall increase in signals of disproportionate reporting with some new signals of disproportionate reporting appearing and some existing signals of disproportionate reporting disappearing; the sensitivity of the signal detection system was slightly increased and the proportion of signals of disproportionate reporting that corresponded to known adverse drug reactions (a measure of efficiency) was unchanged. CONCLUSIONS: The change in legislation has led to a small increase in sensitivity, without affecting the efficiency of the routine statistical measures used. The number of non-serious reports as a proportion of reports in EudraVigilance is likely to increase over time and further monitoring of the impact on signal detection is required. Further work is also required on the qualitative impact of non-serious reports on the nature of signals detected and on their evaluation.

Skin Uptake of 99mTc-HDP in a Case of Annular Elastolytic Giant Cell Granuloma.

Sometimes unexpected extraosseous uptakes appear in a bone scintigraphy as a consequence of a wide spectrum of nonosseous disorders. Recognition of these findings is important to enhance the diagnostic value of bone scintigraphy. We report a case of intense bone scintigraphy cutaneous uptake due to elastolytic actinic giant cell granuloma (EAGCG). We present the case of a patient with intense extraosseous uptakes of Tc-HDP that appeared in a bone scintigraphy that was performed for lumbar pain.