TY - JOUR
T1 - The side effect registry immuno-oncology (SERIO) – A tool for systematic analysis of immunotherapy-induced side effects
AU - Ertl, Carolin
AU - Ruf, Theresa
AU - Mentzer, Dirk
AU - Kong, Mingzi
AU - Kramer, Rafaela
AU - Bergwelt-Baildon, Michael von
AU - Subklewe, Marion
AU - Tomsitz, Dirk
AU - Ascierto, Paolo A.
AU - Dummer, Reinhard
AU - Gogas, Helen
AU - Lebbé, Celeste
AU - Long, Georgina V.
AU - McArthur, Grant
AU - Neilan, Tomas G.
AU - Ribas, Antoni
AU - Robert, Caroline
AU - Schadendorf, Dirk
AU - Zimmer, Lisa
AU - Eigentler, Thomas
AU - Grabbe, Stephan
AU - Forschner, Andrea
AU - Kähler, Katharina C.
AU - Milani, Valeria
AU - Pföhler, Claudia
AU - Hassel, Jessica
AU - Gutzmer, Ralf
AU - Loquai, Carmen
AU - Routy, Bertrand
AU - Furness, Andrew J.S.
AU - Blank, Christian
AU - Wolchok, Jedd D.
AU - French, Lars E.
AU - Hauschild, Axel
AU - Heinzerling, Lucie
N1 - Publisher Copyright:
© 2024
PY - 2024/3/1
Y1 - 2024/3/1
N2 - Background: Immunotherapies such as immune checkpoint inhibitors (ICI) are effective in multiple tumor entities but induce a plethora of side effects. Comprehensive real-world analyses are essential to identify new signals, characterize diagnostic features, enable risk assessment, determine pathomechanisms, assess effectiveness of side effect management and compare tumor outcomes. Methods: The international online `Side-Effect Registry Immuno-Oncology´ (SERIO; www.serio-registry.org) collects rare, complex, and severe immunotherapy-induced side effects across all tumor entities with a strong focus on ICI-induced immune-related adverse events (irAE). The relational database management system (RDMS) contains structured data on patient and tumor characteristics, type of immunotherapy, treatment of side effects, and outcome of tumor and irAE. Data are captured within 25 organ modules including new modules for immune effector cell-associated neurotoxicity syndrome (ICANS) for CAR-T-cell therapies and cytokine release syndrome (CRS) for bispecific antibodies. Information on biological samples is gathered. Results: A total of 1398 irAE cases have been documented by 58 centers from 13 countries in patients with 17 tumor types. IrAEs were induced by nine different immunotherapies including tebentafusp and CAR-T cell therapies, and resulted, among others, in neurological (7.6%), pulmonary (4.0%), and cardiac toxicities (2.9%). 50.0% of all irAEs were graded severe or life-threatening and 23.0% of patients received second-line therapy for steroid-refractory or steroid-dependent irAE. SERIO has contributed to 44 original publications on topics ranging from irMyocarditis to irEncephalitis to long-term persistent sequelae of immunotherapy. Conclusions: A reliable evidence base is crucial for decision-making in rare, complex or therapy-refractory irAE. SERIO can help optimize side effect management and thereby reduce morbidity and mortality induced by immunotherapy.
AB - Background: Immunotherapies such as immune checkpoint inhibitors (ICI) are effective in multiple tumor entities but induce a plethora of side effects. Comprehensive real-world analyses are essential to identify new signals, characterize diagnostic features, enable risk assessment, determine pathomechanisms, assess effectiveness of side effect management and compare tumor outcomes. Methods: The international online `Side-Effect Registry Immuno-Oncology´ (SERIO; www.serio-registry.org) collects rare, complex, and severe immunotherapy-induced side effects across all tumor entities with a strong focus on ICI-induced immune-related adverse events (irAE). The relational database management system (RDMS) contains structured data on patient and tumor characteristics, type of immunotherapy, treatment of side effects, and outcome of tumor and irAE. Data are captured within 25 organ modules including new modules for immune effector cell-associated neurotoxicity syndrome (ICANS) for CAR-T-cell therapies and cytokine release syndrome (CRS) for bispecific antibodies. Information on biological samples is gathered. Results: A total of 1398 irAE cases have been documented by 58 centers from 13 countries in patients with 17 tumor types. IrAEs were induced by nine different immunotherapies including tebentafusp and CAR-T cell therapies, and resulted, among others, in neurological (7.6%), pulmonary (4.0%), and cardiac toxicities (2.9%). 50.0% of all irAEs were graded severe or life-threatening and 23.0% of patients received second-line therapy for steroid-refractory or steroid-dependent irAE. SERIO has contributed to 44 original publications on topics ranging from irMyocarditis to irEncephalitis to long-term persistent sequelae of immunotherapy. Conclusions: A reliable evidence base is crucial for decision-making in rare, complex or therapy-refractory irAE. SERIO can help optimize side effect management and thereby reduce morbidity and mortality induced by immunotherapy.
KW - Bispecific antibodies
KW - CAR-T-cells
KW - Checkpoint inhibitors
KW - Data base
KW - Immune-related adverse events
KW - Online registry
UR - http://www.scopus.com/inward/record.url?scp=85183541882&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2023.113505
DO - 10.1016/j.ejca.2023.113505
M3 - Article
C2 - 38262306
AN - SCOPUS:85183541882
SN - 0959-8049
VL - 199
JO - European Journal of Cancer
JF - European Journal of Cancer
M1 - 113505
ER -