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The side effect registry immuno-oncology (SERIO) - A tool for systematic analysis of immunotherapy-induced side

Carolin Ertl1, Theresa Ruf1, Dirk Mentzer2

  • 1Department of Dermatology and Allergy, LMU University Hospital, LMU Munich, Munich, Germany; SERIO Registry (www.serio-registry.org).

European Journal of Cancer (Oxford, England : 1990)
|January 23, 2024
PubMed
Abstract

Insights

The Side-Effect Registry Immuno-Oncology (SERIO) database captures rare immune-related adverse events (irAEs) from immunotherapy. This real-world data aids in managing severe side effects and improving patient outcomes in immuno-oncology.

Area of Science:

  • Oncology
  • Immunology
  • Pharmacovigilance

Background:

  • Immunotherapies, including immune checkpoint inhibitors (ICI), offer significant clinical benefits across various cancers but are associated with diverse side effects.
  • Real-world data analyses are critical for identifying novel safety signals, understanding diagnostic features, assessing risks, and evaluating treatment outcomes for immunotherapy-induced side effects.

Purpose of the Study:

  • To establish a comprehensive real-world evidence base for rare, complex, and severe immunotherapy-induced side effects.
  • To facilitate improved side effect management, risk assessment, and understanding of pathomechanisms in immuno-oncology.

Main Methods:

  • The international Side-Effect Registry Immuno-Oncology (SERIO) database collects structured data on patient and tumor characteristics, immunotherapy type, side effect management, and outcomes.
  • The registry utilizes a relational database management system with 25 organ modules, including specific modules for immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS).
  • Data capture includes information on biological samples for further investigation.

Main Results:

  • SERIO has documented 1398 immune-related adverse events (irAEs) across 17 tumor types from 58 centers in 13 countries.
  • Neurological (7.6%), pulmonary (4.0%), and cardiac toxicities (2.9%) were among the observed irAEs induced by nine different immunotherapies.
  • Fifty percent of irAEs were severe or life-threatening, with 23.0% of patients requiring second-line therapy for refractory or dependent irAEs.

Conclusions:

  • A robust evidence base is essential for managing rare, complex, or refractory immune-related adverse events.
  • The SERIO registry provides a valuable resource to optimize side effect management, thereby reducing immunotherapy-associated morbidity and mortality.
Keywords:
Bispecific antibodiesCAR-T-cellsCheckpoint inhibitorsData baseImmune-related adverse eventsOnline registry

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