中国临床药理学杂志

安罗替尼联合新辅助化疗对老年三阴性乳腺癌患者的临床研究

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金臻 ^a , 刘昭 ^b , 韩亚东 ^c , 刘钊 ^a , 张家新 ^a

中国临床药理学杂志 | 临床与基础桥接研究 2025,41(21): 3032-3037

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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (21) : 3032 -3037

安罗替尼联合新辅助化疗对老年三阴性乳腺癌患者的临床研究

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金臻^a, 刘昭^b, 韩亚东^c, 刘钊^a, 张家新^a

作者信息

^a.徐州医科大学附属医院甲乳外科，江苏徐州 221000

^b.徐州医科大学附属医院核医学科，江苏徐州 221000

^c.徐州医科大学附属医院普外科，江苏徐州 221000

通讯作者:

刘昭，主任医师，硕士生导师 MP: 13852045643 E-mail: xyfyjrwkjz@163.com

作者简介:

金臻（1989-），女，副主任医师，主要从事乳腺癌耐药机制与靶向干预及甲状腺分子分型与精准治疗体系构建方面的临床工作和研究

Clinical trial of anlotinib combined with neoadjuvant chemotherapy in elderly patients with triple-negative breast cancer

Zhen JIN^a, Zhao LIU^b, Ya-dong HAN^c, Zhao LIU^a, Jia-xin ZHANG^a

Affiliations

^a.Thyroid and Breast Surgery Department, Affiliated Hospital of Xuzhou Medical University, Xuzhou 221000, Jiangsu Province, China

^b.Department of Nuclear Medicine, Affiliated Hospital of Xuzhou Medical University, Xuzhou 221000, Jiangsu Province, China

^c.General Surgery Department, Affiliated Hospital of Xuzhou Medical University, Xuzhou 221000, Jiangsu Province, China

出版时间: 2025-11-17 doi: 10.13699/j.cnki.1001-6821.2025.21.006

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摘要

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目的

研究盐酸安罗替尼胶囊联合新辅助化疗（NAC）对老年三阴性乳腺癌（TNBC）患者的临床疗效和安全性。

方法

将术前行NAC且接受乳腺癌改良根治术的老年TNBC患者，根据治疗方法分为对照组和试验组。对照组行TEC方案术前新辅助治疗，试验组在对照组的基础上，予以盐酸安罗替尼胶囊口服每次12 mg、每日1次，每用药2周停药1周，共治疗4周期。比较2组患者糖类抗原153、癌胚抗原、生长分化因子3、糖类抗原19-9、Ki-67阳性占比、环氧化酶-2、血管内皮生长因子、骨涎蛋白、催乳素、胰岛素样生长因子、临床疗效及长期生存情况，并进行安全性评价。

结果

共纳入93例患者，对照组48例、试验组45例。治疗后，对照组和试验组的客观缓解率分别为43.75%（21例/48例）和64.44%（29例/45例），疾病控制率分别为70.83%（34例/48例）和88.89%（40例/45例），糖类抗原（CA）153分别为（24.59±3.57）和（22.21±3.86）U·mL^-1，生长分化因子3（GDF3）分别为（117.53±18.29）和（102.24±15.47）ng·L^-1，癌胚抗原（CEA）分别为（4.19±0.85）和（3.72±0.64）ng·L^-1，Ki-67阳性占比分别为37.50%和17.78%，环氧化酶-2水平分别为（88.73±21.64）和（74.38±19.51）ng·L^-1，血管内皮生长因子水平分别为（38.23±7.15）和（34.74±6.32）ng·L^-1，无进展生存期率分别为33.33%（16例/48例）和46.67%（21例/45例），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（P<0.05，P<0.01，P<0.001）。试验组和对照组在化疗期间的药物不良反应有贫血、食欲降低、中性粒细胞减少、白细胞减少、血小板减少、头痛、高血压、恶心呕吐、乏力、甲状腺激素升高、腹泻、便秘、感染、脱发、肝肾功能受损、手足综合征。对照组和试验组的药物不良反应总发生率分别为64.58%（31例/48例）、71.11%（32例/45例），在统计学上差异无统计学意义（P>0.05）；对照组和试验组总生存率分别为60.42%（29例/48例）和68.89%（31例/45例），在统计学上差异无统计学意义（P>0.05）。

结论

老年TNBC患者应用盐酸安罗替尼胶囊与NAC联合治疗方案，展现出良好的疗效，可改善Ki-67阳性占比及血清COX-2、血管内皮生长因子水平，改善长期生存情况，安全性高。

关键词

盐酸安罗替尼胶囊 / 新辅助化疗 / 三阴性乳腺癌 / 细胞增殖核抗原 / 环氧化酶-2

Abstract

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Objective

To investigate the efficacy and safety of anlotinib combined with neoadjuvant chemotherapy (NAC) in elderly patients with triple-negative breast cancer (TNBC).

Methods

Elderly patients with TNBC who underwent NAC followed by modified radical mastectomy were enrolled and divided into control group and treatment group based on their treatment regimens. Control group received the TEC regimen as preoperative NAC, while treatment group received additional oral administration of anlotinib hydrochloride capsules (12 mg once daily, in a 2-weeks-on/1-week-off cycle) for 4 cycles. Carbohydrate antigen 153 (CA153), carcinoembryonic antigen (CEA), growth differentiation factor-3 (GdF3), carbohydrate antigen 19-9, Ki-67 positive rate, cyclooxygenase-2 (COX2), vascular endothelial growth factor (VGEF), bone sialoprotein, prolactin, insulin-like growth factor-1, clinical efficacy and long-term survival outcomes were compared between the two groups, and the safety was conducted.

Results

A total of 93 patients were enrolled and divided into control group (n=48) and treatment group (n=45). After treatment, the objective response rates (ORR) were 43.75% (21 cases/48 cases) in control group and 64.44% (29 cases /45 cases) in treatment group, respectively; while the disease control rates (DCR) were 70.83% (34 cases /48 cases) and 88.89% (40 cases /45 cases), respectively; CA 153 levels were (24.59±3.57) and (22.21±3.86) μ·mL^-1, respectively; GdF3 levels were (117.53±18.29) and (102.24±15.47) ng·L^-1, respectively; CEA levels were (4.19±0.85) and (3.72±0.64) ng·L^-1, respectively; the Ki-67 positivity rates were 37.50% and 17.78%, respectively; COX-2 levels were (88.73±21.64) and (74.38±19.51) ng·L^-1, respectively; VEGF levels were (38.23±7.15) and (34.74±6.32) ng·L^-1, respectively; the progression-free survival (PFS) rates were 33.33% (16 cases/48 cases) and 46.67% (21 cases/45 cases), respectively. Statistically significant differences were observed in all the above indicators between the two groups (all P<0.05, P<0.01, P<0.001). The adverse drug reactions during chemotherapy in treatment group and control group included anemia, decreased appetite, neutropenia, leukopenia, thrombocytopenia, headache, hypertension, nausea and vomiting, fatigue, elevated thyroid hormones, diarrhea, constipation, infection, alopecia, impaired liver and kidney function, and hand-foot syndrome. The total incidence of adverse drug reactions was 64.58% (31 cases/48 cases) in control group and 71.11% (32 cases /45 cases) in treatment group, with no statistically significant difference between the groups (P>0.05). The overall survival (OS) rate was 60.42% (29 cases /48 cases) in control group and 68.89% (31 cases /45 cases) in treatment group, and the difference was not statistically significant (P>0.05).

Conclusion

Anlotinib combined with NAC regimen for elderly TNBC patients shows good efficacy, can improve Ki-67 positive rate and serum COX-2 and vascular endothelial growth factor levels, improve long-term survival, and has high safety.

Key words

anlotinib capsule / neoadjuvant chemotherapy / triple-negative breast cancer / nuclear associated antigen Ki67 / cyclooxygenase-2

引用本文

金臻, 刘昭, 韩亚东, 刘钊, 张家新. 安罗替尼联合新辅助化疗对老年三阴性乳腺癌患者的临床研究. 中国临床药理学杂志, 2025 , 41 (21) : 3032 -3037 . DOI: 10.13699/j.cnki.1001-6821.2025.21.006

Zhen JIN, Zhao LIU, Ya-dong HAN, Zhao LIU, Jia-xin ZHANG. Clinical trial of anlotinib combined with neoadjuvant chemotherapy in elderly patients with triple-negative breast cancer[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (21) : 3032 -3037 . DOI: 10.13699/j.cnki.1001-6821.2025.21.006

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2025年第41卷第21期

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doi: 10.13699/j.cnki.1001-6821.2025.21.006

接收时间：2025-05-14
首发时间：2026-08-05
出版时间：2025-11-17

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收稿日期：2025-05-14

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作者信息

^a.徐州医科大学附属医院甲乳外科，江苏徐州 221000

^b.徐州医科大学附属医院核医学科，江苏徐州 221000

^c.徐州医科大学附属医院普外科，江苏徐州 221000

通讯作者:

刘昭，主任医师，硕士生导师 MP: 13852045643 E-mail: xyfyjrwkjz@163.com

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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.21.006

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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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