Academic Journal
Safety profile of tyrosine kinase inhibitors used in non-small-cell lung cancer: An analysis from the Italian pharmacovigilance database
| العنوان: | Safety profile of tyrosine kinase inhibitors used in non-small-cell lung cancer: An analysis from the Italian pharmacovigilance database |
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| المؤلفون: | Barbieri, Maria Antonietta, Sorbara, Emanuela Elisa, Cicala, Giuseppe, Santoro, Vincenza, Cutroneo, Paola Maria, Franchina, Tindara, Santarpia, Mariacarmela, Silvestris, Nicola, Spina, Edoardo |
| المصدر: | Frontiers in Oncology ; volume 12 ; ISSN 2234-943X |
| بيانات النشر: | Frontiers Media SA |
| سنة النشر: | 2022 |
| المجموعة: | Frontiers (Publisher - via CrossRef) |
| الوصف: | Introduction Non-small cell lung cancer (NSCLC) is often caused by molecular alterations that can be detected by predictive biomarkers including mutations or amplifications of several genes. Several tyrosine kinase inhibitors (TKIs) have been approved in Europe by the European Medicines Agency (EMA) for NSCLC. The aim of this study was to analyze the onset of adverse drug reactions (ADRs) related to TKIs in NSCLC through a spontaneous reporting system (SRS) database. Methods All ADR reports having as suspected drug afatinib (AFT), alectinib (ALEC), brigatinib (BRG), ceritinib (CER), crizotinib (CRIZ), erlotinib (ERL), gefitinib (GEF), lorlatinib (LORL), nintedanib (NTB), and osimertinib (OSI) recorded into the Report Reazioni Avverse dei Medicinali (RAM) system database for national data and into the Italian SRS database for Sicilian data and collected from 2006 to 2021 have been evaluated. A descriptive analysis of basal demographic and drug-related characteristics was performed. A case-by-case methodology was conducted paying particular attention to all serious ADR reports collected in Sicily, focusing on type of seriousness, age, sex, concomitant drugs, and comorbidities. Results Of the 3,048 Italian reports, most of ADRs were related to ERL ( n = 1,448), followed by AFT ( n = 435) and GEF ( n = 366). ADR reports were slightly more frequent in females (52.2%) and in the age group >65 years (53.0%). A higher number of cases were related to skin disorders ( n = 1,766; 57.9%), followed by gastrointestinal disorders ( n = 1,024; 33.6%), general disorders and administration site conditions (n = 536; 17.6%), and infections ( n = 483; 15.8%). The case-by-case assessment of Sicilian ADRs showed that 33 cases were serious (12.5%) and mainly involved ERL ( n = 17; 51.5%), occurring in males with a higher onset of respiratory diseases (30.3%) such as respiratory failure, interstitial lung disease and dyspnea. Discussion The analysis of spontaneous ADR reports of TKIs confirmed, in general, well-known risks, which ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| DOI: | 10.3389/fonc.2022.1005626 |
| DOI: | 10.3389/fonc.2022.1005626/full |
| الاتاحة: | http://dx.doi.org/10.3389/fonc.2022.1005626 https://www.frontiersin.org/articles/10.3389/fonc.2022.1005626/full |
| Rights: | https://creativecommons.org/licenses/by/4.0/ |
| رقم الانضمام: | edsbas.F473567A |
| قاعدة البيانات: | BASE |
| DOI: | 10.3389/fonc.2022.1005626 |
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