O2-4-1Multidisciplinary team Management System for Adverse Events Occurring in New Cancer Immunotherapies

Abstract Introduction Recently, promising efficacy has been reported for cell therapies using chimeric antigen receptor (CAR)-T cells, and bispecific T-cell engager antibody (BiTE) - a complex formed with antibodies against CD3 and antibodies against tumor cell surface antigens. However, severe adverse events such as cytokine release syndrome and neurotoxicity result in the incidence of high mortality, which is difficult to predict before initiating these therapies. These symptoms rapidly advance to the severe stage; therefore, a multidisciplinary team management system across the organization is necessary. Method Our multidisciplinary team developed standard operating procedure for adverse events. 1)Preparation of a symptoms checklist and action manual: A symptoms observation checklist and action manual (preparation of the tratment drugs and the treatment flow) were prepared for early detection and to decide on the early treatment approach. 2)Cooperation system with the intensive care unit: Admission and discharge criteria based on symptom severity were laid down. 3)Advance education: Training sessions were held for the expected responders, including holiday/night medical examinations (physicians, nurses, pharmacists, and research coordinators). 4)Communication system and information sharing: The communication system at the time of an event’s onset was clarified, and patient information was shared. Results The actions decided could be implemented, and adverse events could be managed properly. Discussion The careful construction of the management system prior to treatment implementation enables rapid action for the management of adverse events. As many more drugs will introduce into clinical practice in the future, it should be important to continue the verification and improvement of our system.