Literature Analysis of Adverse Drug Reactions Induced by Osimertinib Mesylate / 中国药房

ABSTRACT

OBJECTIVE： To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） induced by osimertinib mesylate， and to provide reference for clinical safe use of drugs. METHODS： Retrieved from PubMed， Wanfang database， CNKI and VIP during database establishment-Aug. 2018， ADR cases of osimertinib mesylate were analyzed retrospectively in respects of patient’s age， gender， nationality， usage and dosage of osimertinib mesylate， occurrence time of ADR， clinical manifestations， treatment measures and outcome， etc. RESULTS： A total of 20 articles were included， involving 21 patients. The age of the patients was 32-82 years old， and the proportion of patients aged 57-79 was the largest （80.9％）. The female with ADR （14 cases） were more than the male. The patients were from 5 countries， in which Japan took the most ratio （13 cases， 61.9％）. The dose of osimertinib mesylate was 160 mg/d in a patient and commonly recommended dose 80 mg/d for other patients. The most ADR cases （16 cases， 76.2％） occurred within 3 months， and no reports of ADR occurred more than 12 months. Organs/systems involved in ADRs were mainly respiratory system （11 case times， 45.8％） and digestive system （6 cases， 25.0％）， in addition， ADR also occurred in cardiovascular system， hematological system， systemic reactions， skin and eyes. Among 21 patients， 3 cases were mild ADR so that they were given same dose with same frequency. A patient suffered from interstitial pneumonia and was given medicine every other day and symptomatic treatment； the symptoms of the patient were relieved. Other 17 cases were relieved after drug withdrawal and symptomatic treatment， but 2 patients died of tumor progression. CONCLUSIONS： In clinical application of osimertinib mesylate， attention should be paid to ADR monitoring， especially short-term ADR， especially ADR of respiratory， digestive system.