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OA北大核心CSTPCD
Clinical trial of naratinib combined with capecitabine in the treatment of advanced breast cancer patients with HER2 positive
目的 观察马来酸奈拉替尼片联合卡培他滨片治疗人表皮生长因子受体-2(HER2)阳性晚期乳腺癌患者的临床疗效及安全性.方法 将HER2阳性晚期乳腺癌患者随机分为对照组和试验组.对照组给予1 250 mg·m-2卡培他滨片,bid,口服给药,治疗2周后停药1周;试验组在对照组治疗的基础上,联合马来酸奈拉替尼片240 mg,qd,口服.2组患者均持续用药至疾病进展或患者无法耐受为止,每3周为1个疗程.比较2组患者的临床疗效、肿瘤标志物水平、生存情况,并评价安全性.结果 试验组入组55例,脱落1例,最终有54例纳入统计分析;对照组入组55例,脱落2例,最终有53例纳入统计分析.治疗后,试验组和对照组的疾病控制率分别为64.81％(35例/54例)和35.85％(19例/53例),客观缓解率分别为37.04％(20例/54例)和18.87％(10例/53例),在统计学上差异均有统计学意义(均P＜0.05).治疗后,试验组和对照组的癌胚抗原水平分别为(14.88±1.96)和(17.25±2.01)ng·mL-1,糖类抗原15-3水平分别为(28.42±4.27)和(32.56±4.85)U·mL-1,组织多肽特异性抗原水平分别为(101.76±10.64)和(106.23±11.16)U·L-1,1 年总生存率分别为31.48％和15.09％,无进展生存时间分别为7.00和6.00个月,总生存时间分别为9.00和8.00个月,在统计学上差异均有统计学意义(均P＜0.05).2组患者的药物不良反应均以腹泻、白细胞减少、手足综合征、恶心、腹痛为主.试验组和对照组的腹泻发生率分别为79.63％和60.38％(P＜0.05);2组患者的其余各药物不良反应发生率比较,在统计学上差异均无统计学意义(均P＞0.05).结论 马来酸奈拉替尼片联合卡培他滨片治疗HER2阳性晚期乳腺癌患者的临床疗效比单用卡培他滨片更佳,前者能更好地降低肿瘤标志物水平,延长生存时间,提高短期生存率.
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.
张团结;巩福玉;卢玉宁;丁亮;李想
阜阳市妇女儿童医院甲乳外科,安徽阜阳 236000
药学
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
naratinib maleate tabletcapecitabine tablethuman epidermal growth factor receptor 2 positiveadvanced breast cancerclinical efficacysafety evaluation
《中国临床药理学杂志》 2024 (017)
2474-2478 / 5
阜阳市科技技术局基金资助项目(FK202081119)
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