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Incidence and characteristics of adverse drug reactions in a cohort of patients treated with PD-1/PD-L1 inhibitors in real-world practice Sabaté Gallego, Mònica Pérez Esquirol, Eulalia García Doladé, Núria Vidal Guitart, Xavier Farriols Danes, Anna Maria Braña Garcia, Irene Carles Galceran, Joan Morales Barrera, Rafael Agustí, Antònia Carreras Soler, Maria Josep Muñoz Couselo, Eva Felip Font, Enriqueta Institut Català de la Salut [Sabaté Gallego M, Vidal Guitart X, Agustí Escasany A] Servei de Farmacologia Clínica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Pérez Esquirol E] Servei de Farmacologia Clínica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Garcia Doladé N] Fundació Institut Català de Farmacologia, Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Carreras Soler MJ, Farriols Danés A] Servei de Farmàcia, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Felip E, Braña I, Carles Galceran J, Morales Barrera R, Muñoz-Couselo E] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Medicaments antineoplàstics - Efectes secundaris Farmacovigilància Pacients CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents Other subheadings::Other subheadings::Other subheadings::/adverse effects DISEASES::Chemically-Induced Disorders::Drug-Related Side Effects and Adverse Reactions COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos ENFERMEDADES::trastornos inducidos químicamente::efectos colaterales y reacciones adversas relacionados con medicamentos Adverse reaction; Immunotherapy; Pharmacovigilance Reacción adversa; Inmunoterapia; Farmacovigilancia Reacció adversa; Immunoteràpia; Farmacovigilància Background: 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. Objectives: To characterize and describe the incidence of ADRs in patients who began immunotherapy treatment in clinical practice. Methods: 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). Results: 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. Conclusion: 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. 2022-10-27T08:59:46Z 2022-10-27T08:59:46Z 2022-08-22 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Sabaté Gallego M, Pérez Esquirol E, Garcia Doladé N, Vidal Guitart X, Carreras Soler MJ, Farriols Danés A, et al. Incidence and characteristics of adverse drug reactions in a cohort of patients treated with PD-1/PD-L1 inhibitors in real-world practice. Front Med. 2022 Aug 22;9:891179. 2296-858X https://hdl.handle.net/11351/8360 10.3389/fmed.2022.891179 36072949 000854930900001 eng Frontiers in Medicine;9 https://doi.org/10.3389/fmed.2022.891179 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Frontiers Media Scientia