Sigurnosni profil inhibitora receptora epidermalnog faktora rasta odobrenih u liječenju ne-sitnostaničnog karcinoma pluća

master's thesis

• Title (english): Adverse drug reactions of epidermal growth factor receptor inhibitors approved for treatment of non-small cell lung cancer
• Author: Dora Kober
• Mentor: Lidija Bach-Rojecky (mentor)
• Committee member: Lidija Bach-Rojecky (predsjednik povjerenstva)
• Committee member: Maja Ortner Hadžiabdić (član povjerenstva)
• Committee member: Nikica Mirošević Skvrce (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmacology); Zagreb
• Defense date and country: 2020-07-14, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Otkriće ključnih onkogenih mutacija pojedinih receptorskih tirozin-kinaza koje dovode do nastanka ne-sitnostaničnog karcinoma pluća, a posebno otkriće mutacija u receptoru epidermalnog faktora rasta, dovelo je do razvoja ciljanog liječenja oboljelih. Cilj ovog diplomskog rada bio je analizirati specifične neželjene učinke EGFR inhibitora odobrenih u liječenju ne-sitnostaničnog karcinoma pluća koji su prijavljeni Hrvatskoj agenciji za lijekove i medicinske proizvode od 2009. godine do 31.5.2020. Prijavljeni slučajevi nuspojava EGFR inhibitora analizirani su prema: ukupnom broju prijavljenih slučajeva nuspojava, spolu i dobi pacijenta, lijeku koji izaziva nuspojave, prijavitelju nuspojava, pripadnosti nuspojava prema klasifikaciji organskih sustava Medicinskog rječnika za regulatorne poslove (eng. Medical Dictionary for Regulatory Activities, MedDRA) te ozbiljnosti nuspojava. Poseban dio analize odnosio se na istodobnu primjenu EGFR inhibitora i drugih lijekova. Ukupno je zaprimljeno 187 prijava sumnji na nuspojavu. Najveći broj pacijenata pripadao je starosnoj skupini između 45 i 64 godina, bilo je više žena od muškaraca, a najviše nuspojava izazvali su erlotinib i afatinib. Najviše neželjenih učinaka prijavljeno je kao poremećaji kože i potkožnog tkiva. Najviše prijavljivana specifična nuspojava bila je osip, bilo je 63 ozbiljnih nuspojava (12 nuspojava je uzrokovalo smrt, 11 hospitalizaciju pacijenata), a u većini slučajeva EGFR inhibitori su ulazili u interakciju s pantoprazolom. Dobiveni rezultati i sveukupno znanje o neželjenim učincima EGFR inhibitora omogućuju njihovo pravovremeno sprječavanje te pravilno liječenje ukoliko ipak dođe do pojave istih.

Abstract (english)

The identification of oncogenic activation of particular receptor tyrosine-kinases in some advanced non-small cell lung cancer (NSCLC) tumors, especially mutations in the epidermal growth factor receptor (EGFR) has led to a paradigm shift and the development of specific molecular treatments for patients. The aim of our study is to describe adverse drug reactions of EGFR inhibitors approved only for the treatment of NSCLC reported to the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) until May 31, 2020. Data were analyzed in respect to the total number of reports, demographic characteristics of the patients, suspected drug, reporter qualification, MedDRA Preferred Terms, seriousness and suspected/interacting active compounds. HALMED received 187 reports related to NSCLC EGFR inhibitors. Most patients belong to 45 – 64 age group. The highest number of cases were reported for erlotinib and afatinib. Most ADRs belonged to the skin and subcutaneous tissue disorders. Most frequently reported MedRA Preferred Terms was rash. There were 63 serious ADRs (12 of them caused death and 11 of them led to hospitalization). In the highest number of cases pantoprazole was reported as the suspected/interacting drug. The knowledge of ADRs enables prevention and adequate management of the ADRs of these important class of drugs.

• Keywords: ne-sitnostanični kracinom pluća; EGFR inhibitori; nuspojave lijeka
• Keywords (english): non-small cell lung cancer; EGFR inhibitors; adverse drug reactions
• Language: croatian
• URN:NBN: urn:nbn:hr:163:565854
• Study programme: Title: Pharmacy; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2021-04-28 09:58:28