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Inicio Medicina Clínica (English Edition) Toxicities from immunotherapy: From clinical trials to real-world clinical pract...
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Vol. 155. Issue 12.
Pages 541-547 (December 2020)
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Vol. 155. Issue 12.
Pages 541-547 (December 2020)
Review
DOI: 10.1016/j.medcle.2020.06.030
Toxicities from immunotherapy: From clinical trials to real-world clinical practice
Toxicidades de la inmunoterapia: de los ensayos clínicos a la práctica clínica en el mundo real
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Mar Riveiro-Barcielaa,b, Ernesto Trallero-Araguásc, Fernando Martínez-Valled,
Corresponding author
ferranmartinezvalle@gmail.com

Corresponding author.
, on behalf of the Vall d’Hebrón Group for the study of Immunotherapy immune-related adverse events
a Liver Unit, Internal Medicine Department, Hospital Universitari Vall d’Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain
b Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
c Rheumatology Unit, Hospital Universitari Vall d’Hebron, Barcelona, Spain
d Systemic Autoimmune Diseases Unit, Internal Medicine Department, Hospital Universitari Vall d’Hebron, Barcelona, Spain
Vall d’Hebrón Committee for management of Immunotherapy immune-related adverse events
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Tables (2)
Table 1. Management of the main grade 3 and 4 immune-mediated adverse events according to the ESMO guidelines in comparison with the current real-world data.
Table 2. Real-world rates of recurrence or de-novo immune-related adverse events (irAEs) in patients who re-challenge immunotherapy after a prior irAE.
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Abstract

In recent years, immunotherapy has become an important pillar of cancer treatment, with high response rates regardless of tumour histology or baseline mutations. However, immune activation associated with check-point inhibitors is not selective and a large variety of immune-related adverse events have been associated with anti-PD1, anti-PD-1/L-1 and anti-CTLA-4 agents. Though diagnosis and treatment of these toxicities have been established according to the recommendations from clinical trials and in line with the autoimmune disorders that they mimic, increasing real-world data is coming up showing that these adverse events may have differential characteristics and management, especially in terms of the use of corticoids, second-line treatments, salvage therapy for life-threatening cases and reintroduction of immunotherapy. Herein we present a comprehensive review of current recommendations and real-world data on the main immune-related adverse events of immunotherapy.

Keywords:
Immunotherapy
Adverse drugs reaction
Hepatitis
Myositis
Cancer
Resumen

En los últimos años la inmunoterapia se ha convertido en un pilar fundamental para el tratamiento del cáncer, con altas tasas de respuesta, independientemente de la histología tumoral o de las mutaciones basales. Sin embargo, la activación inmune asociada a los inhibidores de control no es selectiva, habiéndose asociado una gran variedad de efectos adversos relacionados con la inmunidad a los agentes anti-PD1, anti-PD-1/L-1 y anti-CTLA-4. Aunque se han establecido el diagnóstico y el tratamiento de estas toxicidades en virtud de las recomendaciones de los ensayos clínicos, en consonancia con los trastornos autoinmunes que imitan, el incremento de los datos del mundo real refleja que dichos efectos adversos pueden tener características y manejos diferenciales, especialmente en términos de uso de corticoides, tratamientos de segunda línea, terapia de rescate para casos potencialmente letales, y reintroducción de la inmunoterapia. Presentamos aquí una revisión amplia de las recomendaciones actuales y los datos del mundo real sobre los principales efectos adversos de la inmunoterapia.

Palabras clave:
Inmunoterapia
Reacción adversa a los medicamentos
Hepatitis
Miositis
Cáncer

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