中国临床药理学杂志

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

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亓小改 ^a , 毛沛 ^a , 杜雯 ^a , 刘松岭 ^b , 杨蕾 ^b

中国临床药理学杂志 | 临床与基础桥接研究 2025,41(20): 2887-2892

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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (20) : 2887 -2892

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

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亓小改^a, 毛沛^a, 杜雯^a, 刘松岭^b, 杨蕾^b

作者信息

^a.康复大学青岛中心医院/青岛市中心医院，肿瘤科，山东青岛 250022

^b.康复大学青岛中心医院/青岛市中心医院，乳腺外科，山东青岛 250022

通讯作者:

刘松岭，主任医师 MP: 13954271212 E-mail: qi328710@163.com

作者简介:

亓小改（1986-），女，主治医师，主要从事胸部肿瘤和乳腺肿瘤方面的临床工作和研究

Clinical trail of paclitaxel and carboplatin combined with dual targets in the chemotherapy treatment of HER2-positive metastatic breast cancer

Xiao-gai QI^a, Pei MAO^a, Wen DU^a, Song-ling LIU^b, Lei YANG^b

Affiliations

^a.Department of Oncology, Qingdao Central Hospital, University of Health and Rehabilitation Sciences/Qingdao Central Hospital, Qingdao 250022, Shandong Province, China

^b.Department of Breast Surgery, Qingdao Central Hospital, University of Health and Rehabilitation Sciences/Qingdao Central Hospital, Qingdao 250022, Shandong Province, China

出版时间: 2025-10-28 doi: 10.13699/j.cnki.1001-6821.2025.20.007

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摘要

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目的

观察曲妥珠单抗注射剂+帕妥珠单抗注射剂（HP）双靶联合紫杉醇注射剂（白蛋白结合型）+卡铂注射剂与单独联合紫杉醇注射剂化疗方案治疗人表皮生长因子受体2（HER2）阳性转移性乳腺癌的临床疗效和安全性。

方法

将患者根据治疗方法分为对照组与试验组。对照组用HP双靶（注射用曲妥珠单抗，首剂8 mg·kg^-1、之后6 mg·kg^-1+帕妥珠单抗注射液首剂840 mg、之后420 mg）联合紫杉醇注射剂（125 mg·m^-2）方案化疗；试验组在对照组基础上加用卡铂注射剂（药时曲线下面积为6），21 d为1周期，共6个周期。比较2组患者的临床疗效、肿瘤标志物水平和生存获益情况，并进行安全性评价。

结果

本研究共纳入106例，其中对照组52例，试验组54例。治疗后，试验组和对照组的客观缓解率分别为74.07%（40例/54例）和53.85%（28例/52例），糖类抗原15-3（CA153）分别为（21.82±3.22）和（23.56±3.43）U·mL^-1；癌胚抗原（CEA）分别为（2.22±0.53）和（2.51±0.63）μg·L^-1；血管内皮生长因子A（VEGFA）分别为（53.51±7.44）和（57.43±8.04）ng·mL^-1；三叶因子1（TFF1）分别为（1.51±0.43）和（1.74±0.59）mg·L^-1；试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）；抗药抗体（ADA）阳性率分别为3.85%和1.85%；中和抗体（NAB）阳性率分别为1.92%和1.85%，2组间比较，在统计学上差异均无统计学意义（均P>0.05）。试验组的中位无进展生存期（PFS）为14.5月，显著高于对照组的11.3月；试验组的中位总生存期（OS）为30.0月，显著高于对照组的25.4月（均P<0.05）。试验组和对照组的生存率分别为75.93%和57.69 %，在统计学上差异有统计学意义（P<0.05）。治疗期间，试验组患者发生脱发34例（62.96%）、恶心25例（46.30%）、呕吐19例（35.19%），对照组患者发生脱发43例（82.69%）、恶心11例（21.15%）、呕吐8例（15.38%），试验组患者的恶心、呕吐发生率均显著高于对照组，脱发发生率显著低于对照组（均P<0.05）。

结论

HP双靶联合紫杉醇注射剂+卡铂注射剂化疗方案相较于单独联合紫杉醇注射剂化疗方案能够更为有效降低HER2阳性转移性乳腺癌患者肿瘤标志物水平，改善患者的近期疗效和远期预后，同时，2组的血清免疫原性特征相似。

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

Abstract

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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.

Key words

paclitaxel injection / carboplatin injection / dual-targeted therapy / breast cancer / human epidermal growth factor receptor 2 / chemotherapy regimen

引用本文

亓小改, 毛沛, 杜雯, 刘松岭, 杨蕾. 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. 中国临床药理学杂志, 2025 , 41 (20) : 2887 -2892 . DOI: 10.13699/j.cnki.1001-6821.2025.20.007

Xiao-gai QI, Pei MAO, Wen DU, Song-ling LIU, Lei YANG. Clinical trail of paclitaxel and carboplatin combined with dual targets in the chemotherapy treatment of HER2-positive metastatic breast cancer[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (20) : 2887 -2892 . DOI: 10.13699/j.cnki.1001-6821.2025.20.007

基金

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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)

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2025年第41卷第20期

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文章信息

doi: 10.13699/j.cnki.1001-6821.2025.20.007

接收时间：2025-05-14
首发时间：2026-08-07
出版时间：2025-10-28

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收稿日期：2025-05-14

基金

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)

作者信息

^a.康复大学青岛中心医院/青岛市中心医院，肿瘤科，山东青岛 250022

^b.康复大学青岛中心医院/青岛市中心医院，乳腺外科，山东青岛 250022

通讯作者:

刘松岭，主任医师 MP: 13954271212 E-mail: qi328710@163.com

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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.20.007

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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