中国临床药理学杂志2025，Vol.41Issue(20)：2887-2892,6.DOI:10.13699/j.cnki.1001-6821.2025.20.007
紫杉醇和卡铂联合双靶化疗治疗HER2阳性转移性乳腺癌的临床研究
Clinical trail of paclitaxel and carboplatin combined with dual targets in the chemotherapy treatment of HER2-positive metastatic breast cancer
摘要
Abstract
Objective To observe the clinical efficacy and safety of 2 chemotherapy regimens in the treatment of metastatic breast carcinoma with overexpression of human epidermal growth factor receptor 2(HER2):one was the dual-targeted therapy with herceptin injection+pertuzumab injection(herceptin+pertuzumab,HP)combined with paclitaxel injection(albumin-bound)+carboplatin injection,and the other was HP dual-targeted therapy combined with paclitaxel injection alone.Methods Patients were divided into control group and treatment group based on the treatment regimen.Control group received HP dual-targeted therapy(herceptin for injection:initial dose of 8 mg·kg-1,followed by 6 mg·kg-1;pertuzumab injection:initial dose of 840 mg,followed by 420 mg)combined with paclitaxel injection(125 mg·m-2)for chemotherapy.Treatment group additionally received carboplatin injection with an area under the curve(AUC)of 6 on the basis of the treatment regimen of control group,with 21 days as one cycle,for a total of 6 cycles.The clinical efficacy,levels of tumor markers,survival benefits of the 2 groups were compared,and safety evaluation was also conducted.Results The control and treatment groups comprised 52 and 54 subjects,respectively.After treatment,the objective response rates of the treatment group and the control group were 74.07％(40 cases/54 cases)and 53.85％(28 cases/52 cases),respectively,the carbohydrate antigen 15-3(CA153)levels were(21.82±3.22)and(23.56±3.43)U·mL-1,respectively;the carcinoembryonic antigen(CEA)were(2.22±0.53)and(2.51±0.63)μg·L-1,respectively;the levels of vascular endothelial growth factor A(VEGFA)were(53.51±7.44)and(57.43±8.04)ng·mL-1,respectively;trefoil factor 1(TFF1)were(1.51±0.43)and(1.74±0.59)mg·L-1,respectively;there were significant differences in the above indexes between experimental group and control group(all P＜0.05);the positive rates of anti-drug antibody(ADA)were 3.85％and 1.85％,respectively and the positive rates of neutralizing antibody(NAB)were 1.92％and 1.85％respectively,without statistically significant differences(all P＞0.05).The median progression free survival(PFS)of treatment group was 14.5 months,which was significantly higher than that of control group(11.3 months);the median overall survival(OS)of treatment group was 30.0 months,which was significantly higher than 25.4 months of control group(all P＜0.05).Survival advantage was observed in treatment group(75.93％)compared to control group(57.69％),win statistically significant difference(P＜0.05).During treatment,34 patients(62.96％)in treatment group experienced alopecia,25(46.30％)had nausea and 19(35.19％)had vomiting;in control group,43 patients(82.69％)had alopecia,11 patients(21.15％)had nausea,and 8 patients(15.38％)had vomiting.Compared with control group,treatment group had statistically significantly higher incidence of nausea and vomiting,and statistically significantly lower incidence of alopecia(all P＜0.05).Conclusion Compared with the regimen of HP dual-targeted therapy combined with paclitaxel injection alone,the regimen of HP dual-targeted therapy combined with paclitaxel injection+carboplatin injection can more effectively reduce the levels of tumor markers in patients with HER2-positive metastatic breast cancer,improve the short-term and long-term efficacy and prognosis of patients,and the two regimens have similar serum immunogenic characteristics.关键词
紫杉醇注射剂/卡铂注射剂/双靶/乳腺癌/人表皮生长因子受体2/化疗方案Key words
paclitaxel injection/carboplatin injection/dual-targeted therapy/breast cancer/human epidermal growth factor receptor 2/chemotherapy regimen分类
医药卫生引用本文复制引用
QI Xiao-gai,MAO Pei,DU Wen,LIU Song-ling,YANG Lei..紫杉醇和卡铂联合双靶化疗治疗HER2阳性转移性乳腺癌的临床研究[J].中国临床药理学杂志,2025,41(20):2887-2892,6.基金项目
吴阶平医学基金会临床科研专项基金资助项目(320.6750.2023-18-108) （320.6750.2023-18-108）
