Regorafenib is an oral multikinase inhibitor that has shown antitumor activity in a range of solid tumors. Based on data from phase III clinical trials, regorafenib is indicated for the treatment of adult patients with metastatic colorectal cancer who have previously been treated with, or are not considered candidates for, other available therapies, and in patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other appropriate treatments. A panel of oncology nurses, research coordinators, and other medical oncology experts, experienced in the care of patients treated with regorafenib, met to discuss the best practice for the management of regorafenib-associated adverse events (AEs). The panel agreed that, in clinical trials and daily practice with regorafenib, AEs are common but mostly manageable. The most common and/or important AEs associated with regorafenib were considered to be hand–foot skin reaction, rash or desquamation, stomatitis, diarrhea, hypertension, liver abnormalities, and fatigue. This manuscript describes the experience and recommendations of the panel for managing these AEs in everyday clinical practice. Appropriate education, monitoring, and management are considered essential for reducing the incidence, duration, and severity of regorafenib-associated AEs.

In this chapter we address the challenge of responding to climate-related issues for vulnerable nations such as Haiti by adopting a non-formal radio-based approach to educate adults outside of the school system. We argue that to inform populations on climate change, we cannot solely rely on the K-12 school system. This is especially true for countries such as Haiti. where there is an inadequate education infrastructure, and much of the population, both juveniles, and adults, is not in school or has not attended school for some time. The effects of climate change are changing the lives of people globally, and third-world nations such as Haiti are even more susceptible to climate-related disasters. Given the severity of ongoing circumstances, a sense of urgency is necessary, and addressing the issue requires an approach that has a far, broad and rapid reach and concludes in immediate climate action as opposed to delayed. In order to efficiently respond to climate-related events, a population needs to build resilience through awareness, understanding, and skill development in the context of the country and region, which in this chapter is specifically Port-au-Prince, Haiti.

PURPOSE Cyberattacks are increasing in health care and cause immediate disruption to patient care, have a lasting impact, and compromise scientific integrity of affected clinical trials. On the May 14, 2021, the Irish health service was the victim of a nationwide ransomware attack. Patient care was disrupted across 4,000 locations, including 18 cancer clinical trials units associated with Cancer Trials Ireland (CTI). This report analyses the impact of the cyberattack on the organization and proposes steps to mitigate the impact of future cyberattacks. METHODS A questionnaire was distributed to the units within the CTI group; this examined key performance indicators for a period of 4 weeks before, during, and after the attack, and was supplemented by minutes of weekly conference call with CTI units to facilitate information sharing, accelerate mitigation, and support affected units. A total of 10 responses were returned, from three private and seven public hospitals. RESULTS The effect of the attack on referrals and enrollment to trials was marked, resulting in a drop of 85% in referrals and 55% in recruitment before recovery. Radiology, radiotherapy, and laboratory systems are heavily reliant on information technology systems. Access to all was affected. Lack of preparedness was highlighted as a significant issue. Of the sites surveyed, two had a preparedness plan in place before the attack, both of these being private institutions. Of the eight institutions where no plan was in place, three now have or are putting a plan in place, whereas no plan is in place at the five remaining sites. CONCLUSION The cyberattack had a dramatic and sustained impact on trial conduct and accrual. Increased cybermaturity needs to be embedded in clinical trial logistics and the units conducting them.

e13614 Background: Cancer trials in Ireland are conducted in both public Health Service Executive (HSE) and private hospitals and are overseen by Cancer Trials Ireland (CTI). On the 14th of May 2021 the Irish National HSE was the victim of a “Conti” ransomware attack. The attack triggered a “Critical Incident Process,” and the shutting down of all HSE IT systems at a national level. Disruption to patient care across the HSE’s 4000 locations, 54 acute hospitals, and 70,000 connected devices was drastic, immediate and without warning. Methods: The purpose of this study is to quantify the impact of the attack on the clinical trials network. A questionnaire was distributed by CTI to the 16 trials units within the group, this examined patient referrals and key performance indexes for a period of 4 weeks; prior, during, and after the attack. A total of 10 responses were returned, with a split of 3 private and 7 HSE hospitals. Results: The effect of the attack on referrals and enrollment to clinical trials was marked. In the 4 weeks prior to the attack 273 patients in total were referred to the trials units for screening, this fell to 41 patients in the 4 weeks during and recovering to 323, 4 weeks after. 49 patients were enrolled in trials prior the attack, 22 during and 38 after, a drop of 85% in referrals and 55% in recruitment to trials before recovery. Radiotherapy delivery was interrupted for patients on treatment or delayed for those initiating it. Radiology, lab systems and radiotherapy are heavily reliant on IT systems. Access to all was impacted, with only urgent diagnostic tests being carried out. Requesting tests and reports pivoted to a paper based systems. With staff having to present in person to request and collect reports. Patient safety was prioritized, with accurate paper records and logs in lieu of electronic records. Scientific integrity of trials involving combined modality or radiotherapy was compromised in HSE hospitals. No change in adverse outcomes was reported across all units surveyed before, during and after the attack. Normal access to emails in sites that were impacted ranged from days at a minimum to 6 weeks in the worst affected centers. Normal access to radiology and lab tests took on average 26 and 32 days respectively. Conclusions: A significant issue highlighted by the cyber-attack was the lack of redundancy in the IT systems used throughout Irish hospitals on a daily basis and a lack of a plan when these systems fail. Of the 10 sites surveyed, 2 had a preparedness plan in place prior to the attack, both of these private institutions. Of the 8 institutions where no plan was in place only 3 now have or are putting a plan in place, no plan is in place in the 5 remaining sites. At this time one HSE hospital has been subject to a repeat ransomware attack and patient data from another has been released on the dark web. Reviewing the impact of the cyber attack on CTI highlights the usefulness of preparedness, with units that had a plan in place prior to the attack least affected overall.