中国临床药理学杂志2024，Vol.40Issue(17)：2474-2478,5.DOI:10.13699/j.cnki.1001-6821.2024.17.004
奈拉替尼联合卡培他滨治疗HER2阳性晚期乳腺癌患者的临床研究
Clinical trial of naratinib combined with capecitabine in the treatment of advanced breast cancer patients with HER2 positive
摘要
Abstract
Objective To observe the clinical efficacy and safety of naratinib maleate tablets combined with capecitabine tablets in the treatment of advanced breast cancer patients with human epidermal growth factor receptor 2(HER2)positive.Methods The advanced breast cancer patients with HER2 positive were randomly divided into control group and treatment group.The control group was given 1 250 mg·m-2 capecitabine tablets,bid,orally administered,and stopped for 1 week after 2 weeks of treatment.On the basis of treatment in the control group,the treatment group was treated with a combination of naratinib maleate tablets 240 mg,qd,orally.Both groups of patients continued to take medication until the disease progressed or the patient could not tolerate it,with one course of treatment every three weeks.The clinical efficacy,tumor marker levels,survival status,and the safety was evaluated.Results Treatment group were enrolled 55 cases,1 case dropped out,and 54 cases were finally included in the statistical analysis.Control group were enrolled 55 cases,2 cases dropped out,and 53 cases were finally included in the statistical analysis.After treatment,the disease control rates of treatment and control groups were 64.81％(35 cases/54 cases)and 35.85％(19 cases/53 cases);the objective response rates were 37.04％(20 cases/54 cases)and 18.87％(10 cases/53 cases);the differences were statistically significant(all P＜0.05).After treatment,the levels of carcinoembryonic antigen in the treatment and control groups were(14.88±1.96)and(17.25±2.01)ng·mL-1;the levels of carbohydrate antigen 15-3 were(28.42±4.27)and(32.56±4.85)U·mL-1;the levels of tissue peptide specific antigen were(101.76±10.64)and(106.23±11.16)U·L-1;the overall one-year survival rates were 31.48％and 15.09％;the progression free survival time was 7.00 and 6.00 months;the total survival time was 9.00 and 8.00 months,respectively.The differences of above indexes were statistically significant(all P＜0.05).The adverse drug reactions of two groups were mainly diarrhea,leukopenia,hand foot syndrome,nausea and abdominal pain.The incidences of diarrhea in the treatment and control groups were 79.63％and 60.38％with significant difference(P＜0.05);and there were no significant differences in the incidence of other adverse drug reactions between two groups(all P＞0.05).Conclusion The clinical efficacy of naratinib maleate tablets combined with capecitabine tablets in the treatment of the advanced breast cancer is better than that of capecitabine alone;the former can better reduce the levels of tumor markers,prolong the survival time,and improve the short-term survival rate.关键词
马来酸奈拉替尼片/卡培他滨片/人表皮生长因子受体-2阳性/晚期乳腺癌/临床疗效/安全性评价Key words
naratinib maleate tablet/capecitabine tablet/human epidermal growth factor receptor 2 positive/advanced breast cancer/clinical efficacy/safety evaluation分类
医药卫生引用本文复制引用
张团结,巩福玉,卢玉宁,丁亮,李想..奈拉替尼联合卡培他滨治疗HER2阳性晚期乳腺癌患者的临床研究[J].中国临床药理学杂志,2024,40(17):2474-2478,5.基金项目
阜阳市科技技术局基金资助项目(FK202081119) （FK202081119）
