The expected value of this project is to identifying predictive factors of immune-related adverse events (irAEs), and discover whether these factors are different according to biology (sex) and gender-related characteristics. This is of great value for cancer patients who are being treated with immunotherapeutics. A key challenge in modern oncology is to match patients with the particular targeted drug most likely to improve their outcome, whilst not being associated with serious adverse treatment events. This project will test our hypothesis that sex and gender related factors play a role in a patient’s response to immunotherapy and the occurrence of irAEs. The study results, being obtained in a “real world” (outside experimental clinical trial setting), will be more easily translated in a ready to use irAEs timely diagnosis and personalization of treatment approaches. The results of our study will also provide actionable knowledge in the following areas: a. Translating our findings towards better clinical practice. We will use the information gathered in the project to determine which patients are likely to suffer from immune related adverse events when they recieve immunotherapeutics.  This information will be of especial importance to both pharmaceutical companies and clinicians, as it will allow them to identify a personalised treatment for patients who will undergo treatment with immunotherapeutics. Towards completion of our project we will engage with pharmaceutical companies to discuss how our results can be utilised to inform selection for future clinical trials.
b. Accelerating the translation of biomedical research results towards clinical validation: The results of our specimens testing will potentially identify novel biomarkers of response to immune checkpoint inhibitors and provide a pathway to identify those patients who will likely suffer from irAEs.  By using a highly coordinated approach we can facilitate the fast-tracking of the clinical testing of either DNA/RNA alterations in patients as predictors of IRAEs. Indeed, this project offers a unique opportunity to pharmaceutical companies/research groups to demonstrate an actionable pathway that uses clinical biospecimens to directly inform patient recruitment to future clinical trials.

This model can be utilised in future studies to inform selection of patients for specific targeted anti-cancer therapies. The project also provides value for the academic community, as we will establish a paradigm example of how patient specimens can be used to identify which patients are likely to suffer from IRAEs, which will provide valuable information for basic research and medical oncologists.
c. Reducing costs in the healthcare system: It is estimated that the EU spent €51 billion on cancer-related healthcare in 2009, with the per-patient costs varying between countries. Non-healthcare-related costs of cancer are also significant, with untimely death costing an estimated €42 billion and lost working days costing and €9.4 billion (Luengo-Fernandez et al, Lancet Oncol. Epub 2013. DOI: 10.1016/S1470-2045(13)70442-X.2013). Other factors, such as unpaid care of patients by friends and relatives (estimated to cost €23 billion), all contribute to the economic impact of cancer. There is a need to provide cost effective treatments that will reduce the cost burden on both Europe and further afield relating to the use of ineffective treatments on patients that will not benefit, while maximising precious resources on those that will benefit. The results of this study will result in potential cost savings for the Health Service Executive and Governments as we will identify a specific cohort of patients likely to respond to these treatments. This will reduce the cost burden on both patients and healthcare providers.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 741874. More information on the http://gender-net-plus.eu/ The contents of this website and the view expressed in the news and publications are the sole responsibility of the authors and under no circumstances can be regarded as reflecting the position of the European Union.
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