Working Group on Governance of the Regional Database & Estimation System (WGRDBES-GOV; Outputs from 2020 meeting)

The Working Group on Governance of the Regional Database & Estimation System (WGRDBESGOV) provides the governance function for both the existing Regional Database (RDB) and the new Regional Database & Estimation System (RDBES) that is currently in development. It is composed of representatives from ICES member countries and EU Regional Coordination Groups (RCGs). In this report, the WGRDBESGOV reviews the RDBES developments performed during 2020 and plans for the work required in 2021 and beyond. It also considers how RDB data has been used and proposes changes required to the current Data Policy. The RDBES is currently planned to replace both the existing ICES InterCatch and RDB database systems and has an important part to play in increasing transparency and improving the quality of stock assessment within ICES. To this end, two workshops have been planned for 2021 which will help data submitters with the transition to the new system. A new working group is also proposed to enable the ICES community to move forward with estimation using the RDBES data model. Following on from the data call issued in 2020, another test data call is also planned for 2021 which will give further motivation for people to become involved and provide a robust test of the process. The RDB and RDBES must ensure that data can be used by the RCGs and authorised groups in ICES whilst ensuring that only permitted users have access to the confidential data – the rules relating to this have previously been defined in the RDB Data Policy. In line with discussions at the ICES Data and Information Group (DIG), it is proposed to split the current Data Policy into two new documents: a Data License, and a Data Governance document. It is important to remember that the ultimate success of the RDBES will rely on the effort and contributions from a large number of people in the wider ICES/EU data collection community and not just the relatively small groups who attend the WGRDBESGOV or Core Group meetings. The WGRDBESGOV continues to encourage these contributions

Immune-Related Thyroid Adverse Events Predict Response to PD-1 Blockade in Patients with Melanoma

Antibodies against programmed cell death protein-1 or its ligand (PD-(L)1) are a standard of care in melanoma; however, this treatment may cause immune-related adverse events. The aim of this study was to evaluate the immune-related thyroid adverse events (irTAEs) during anti-PD-1 therapy and analyze their influence on the overall survival rates in melanoma. We included 249 patients with metastatic melanoma treated in our institution between 2014 and 2021; the median age was 62 years (range: 17–90); 58% were males, and 37% of patients had the BRAF mutation. We included patients with a normal TSH at baseline and followed up with measurement of TSH levels during immunotherapy. In our group, 95 patients had a TSH outside the normal range: 63 not clinically significant and 32 with clinical symptoms of hypothyroidism. The 3-year overall survival rate was related to the irTAEs of clinical hypothyroidism, abnormal clinically not significant TSH, and euthyreosis at 56%, 43%, and 32%, respectively (p = 0.002). After adjusting the Cox model for potential confounding variables, clinically significant hypothyroidism was an independent prognostic factor with HR 0.51 (95% CI 0.29–0.87). In conclusion, the patients who developed clinically significant hypothyroidism requiring replacement therapy with L-thyroxin were the group who benefitted most from anti-PD-1 treatment

Working Group on Governance of the Regional Database and Estimation System (WGRD-BESGOV; outputs from 2021 meeting)

The Working Group on Governance of the Regional Database & Estimation System (WGRDBESGOV) provides the governance function for both the existing Regional Database (RDB) and the new Regional Database & Estimation System (RDBES) that is currently in development. It is composed of representatives from ICES member countries and EU Regional Coordination Groups (RCGs). In this report the WGRDBESGOV reviews the RDBES developments performed during 2021 and plans for the work required in 2022 and beyond. It also considers how RDB data has been used and proposes changes required to the current Data Policy