中国临床药理学杂志2025，Vol.41Issue(18)：2605-2610,6.DOI:10.13699/j.cnki.1001-6821.2025.18.006
埃克替尼治疗纵隔复发性鳞状细胞癌患者的临床研究
Clinical study of icotinib in the treatment of patients with recurrent mediastinal squamous cell carcinoma
摘要
Abstract
Objective To observe the clinical efficacy and safety of icotinib in the treatment of patients with recurrent mediastinal squamous cell carcinoma.Methods Patients with recurrent mediastinal squamous cell carcinoma were randomly divided into control group and treatment group using a random number table.Control group received docetaxel injection 75 mg·m-2,intravenous infusion,once every 3 weeks for 4 cycles;treatment group received icotinib 150 mg,orally,3 times daily for 12 consecutive weeks.The clinical efficacy,disease control rate,progression-free survival,quality of life scores,physiological laboratory indicators and the incidence of adverse drug reactions were compared between the two groups.Results A total of 105 patients were enrolled,3 cases were excluded during the trial,leaving 52 participants in treatment group and 50 in control group.After treatment,the objective response rates(ORR)for treatment group and control group were 42.31％(22 cases/52 cases)and 32.00％(16 cases/50 cases);the disease control rates(DCR)were 76.92％(40 cases/52 cases)and 60.00％(30 cases/50 cases);the median progression-free survival(PFS)were 5.60 and 4.20 months;the median overall survival(OS)were 16.90 and 10.50 months;the overall health status were(72.61±13.96)and(63.62±16.94)points,respectively;the functional scale scores were(80.19±15.73)and(68.39±14.55)points,respectively;the symptom scale scores were(31.41±12.61)and(41.81±10.57)points,respectively;white blood cell count(WBC)were(2.31±1.50)and(4.45±1.00)× 109 cell·L-1;neutrophil count(NEU)were(3.70±1.38)and(1.96±0.95)× 109 cell·L-1;hemoglobin(Hb)were(119.39±17.40)and(109.98±14.04)g·L-1;platelet count(PLT)were(217.68±50.33)and(164.93±56.01)× 109 cell·L-1.Compared with control group,the above indexes in treatment group all had significant differences(all P＜0.05).The main adverse drug reactions in treatment group were rash,diarrhea and elevated transaminase;in control group were bone marrow suppression,alopecia,nausea and vomiting.There was no significant difference in the total incidence of adverse drug reactions between the two groups(82.69％vs.90.00％,P＞0.05).However,the incidence of grade 3-4 adverse drug reactions in treatment group was significantly lower than that in control group(11.54％vs.30.00％,P＜0.05).Conclusion Icotinib tablet is more effective than docetaxel injection in treating recurrent mediastinal squamous cell carcinoma,with less hematological toxicity,lower incidence of severe adverse reactions,and better safety profile.关键词
埃克替尼片/多西他赛注射液/纵隔复发性鳞状细胞癌/临床疗效/药物不良反应Key words
icotinib tablet/docetaxel injection/recurrent mediastinal squamous cell carcinoma/clinical efficacy/adverse reactions分类
医药卫生引用本文复制引用
舒德军,沈玉光,唐激扬,周维富,卢勋,梅永..埃克替尼治疗纵隔复发性鳞状细胞癌患者的临床研究[J].中国临床药理学杂志,2025,41(18):2605-2610,6.基金项目
贵州省科技计划基金资助项目(黔科合基础-[2024]青年268号) （黔科合基础-[2024]青年268号）
贵州省遵义市科技局科技计划基金资助项目(遵市科合HZ字(2021)272号) （遵市科合HZ字(2021）
