Incidence and characteristics of adverse drug reactions in a cohort of patients treated with PD-1/PD-L1 inhibitors in real-world practice
Sabaté, Mònica (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Pérez, Eulàlia (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Garcia Doladé, Núria (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Vidal Guitart, Xavier (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Carreras Soler, Maria Josep (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Farriols Danés, Anna (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Felip, Enriqueta (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Braña, Irene (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Carles, Joan (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Morales-Barrera, Rafael (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Muñoz Couselo, Eva (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Agustí Escasany, M. Antònia (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	Data related to adverse drug reactions (ADRs), specifically immune-related adverse events (irAEs), in long-term treatment with immunotherapy in real-world practice is scarce, as is general information regarding the management of ADRs. To characterize and describe the incidence of ADRs in patients who began immunotherapy treatment in clinical practice. In a prospective observational study cancer patients ≥18 years of age who were treated with a monotherapy regime of PD-1/PD-L1 inhibitors were evaluated. The study period was from November 2017 to June 2019 and patients were followed up until June 2021. Patients were contacted monthly by telephone and their electronic health records were reviewed. Each ADR was graded according to the Common Terminology Criteria for Adverse Events (CTCAE 5. 0). Out of 99 patients, 86 met the inclusion criteria. Most were male (67. 4%), with a median age of 66 (interquartile range, IQR: 59-76). The most frequent cancer was non-small cellular lung cancer (46 cases, 53. 5%), followed by melanoma (22, 25. 6%). A total of 74 patients (86%) were treated with anti-PD-1 drugs and 12 (14%) were treated with anti-PD-L1 drugs. The median treatment durations were 4. 9 (IQR: 1. 9-17. 0) and 5. 9 months (IQR: 1. 2-12. 3), respectively. Sixty-three patients (73%) developed from a total of 156 (44% of the total number of ADR) irADRs, wherein the most frequent were skin disorders (50 cases, 32%, incidence = 30. 5 irADRs/100 patients per year [p-y]), gastrointestinal disorders (29, 19%, 17. 7 irADRs/100 p-y), musculoskeletal disorders (17, 11%, 10. 4 irADRs/100 p-y), and endocrine disorders (14, 9%, 8. 6 irADRs/100 p-y). A total of 22 irADRs (14%) had a latency period of ≥12 months. Twelve irADRs (7. 7%) were categorized as grade 3-4, and while 2 (1. 3%) were categorized as grade 5 (death). Sixty-one irADRs (39. 1%) in 36 patients required pharmacological treatment and 47 irADRs (30. 1%) in 22 patients required treatment with corticosteriods. The majority of patients treated with anti-PD1/PDL1-based immunotherapy experienced adverse reactions. Although most of these reactions were mild, 11. 5% were categorized as grade 3 or above. A high percentage of the reactions were immune-related and occurred throughout the treatment, thereby indicating that early identification and close monitoring is essential.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Adverse reaction ; Immune-related adverse reaction ; Immunotherapy ; Pharmacovigilance ; Real-world practice
Published in:	Frontiers in Medicine, Vol. 9 (august 2022) , ISSN 2296-858X

DOI: 10.3389/fmed.2022.891179
PMID: 36072949

14 p, 928.6 KB

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