title: Observation of hepatotoxicity during long-term gefitinib administration in patients with non-small-cell lung cancer.
abstract: To observe drug-induced hepatotoxicity by long-term gefitinib administration in the treatment of non-small-cell lung cancer. The data of 101 patients with locally advanced or metastatic non-small-cell lung cancer, for which gefitinib had been used orally for 3 months or longer, were retrospectively analyzed. The median duration of gefitinib administration was 14 months (3-60 months). Forty patients (39.6%) developed abnormal hepatic function, among whom 30 patients (29.7%) had grade I hepatotoxicity, six patients (5.9%) had grade II, and four patients (4.0%) had grade III, respectively. The median time from starting gefitinib oral therapy to developing liver dysfunction was 4 months (1-23 months) for the entire cohort. The incidence of hepatotoxicity in the group with a duration of more than 14 months was much higher than that in the group with a duration of less than 14 months (52.0 vs. 27.5%, P=0.012). In thirty-two patients (32/40), abnormal liver function resolved with hepatoprotective treatment, whereas eight patients (8/40) had persistent grade I hepatotoxicity until the last follow-up. Our study showed that long-term gefitinib-induced hepatotoxicity was a common adverse event, especially for the cohort with a duration of longer than 14 months. In most patients with hepatotoxicity, normal liver function was restored and discontinuation of gefitinib was not necessary.
authors.affiliation: aDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing bDepartment of Medical Oncology, Nanyang Central Hospital, Nanyang, Henan, China.
authors.forename: Jingjing
authors.initials: J
authors.lastname: Wang
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Wu
authors.forename: Mei
authors.initials: M
authors.lastname: Dong
authors.forename: Xiaohui
authors.initials: X
authors.lastname: He
authors.forename: Ziping
authors.initials: Z
authors.lastname: Wang
authors.forename: Junling
authors.initials: J
authors.lastname: Li
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D056486:Chemical and Drug Induced Liver Injury / Q000188:drug therapy / Q000209:etiology*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000009:adverse effects*; D012189:Retrospective Studies; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib