曲妥珠单抗联合奈拉替尼治疗HER-2阳性转移性乳腺癌的疗效

doi:10.11958/20241942

摘要/Abstract

摘要：

目的探讨曲妥珠单抗联合奈拉替尼治疗表皮生长因子受体（HER）-2阳性转移性乳腺癌的疗效及对患者免疫功能和生活质量的影响。方法选取HER-2阳性转移性乳腺癌患者82例，随机分为奈拉替尼组和联合组，各41例。奈拉替尼组给予马来酸奈拉替尼治疗，联合组在奈拉替尼组基础上给予注射用曲妥珠单抗治疗，均治疗6个疗程。统计治疗后患者症状缓解情况；治疗前、后采用乳腺癌患者生命质量测定量表（FACT-B）评估患者生活质量；采用酶联免疫吸附试验检测免疫功能指标（CD4⁺、CD8⁺、CD4⁺/CD8⁺）、肿瘤标志物[糖类抗原（CA）125、CA153、癌胚抗原（CEA）]水平；并记录治疗期间患者不良反应发生情况。结果联合组患者临床症状总缓解率高于奈拉替尼组（P<0.05）。治疗前，2组生活质量、免疫功能及肿瘤标志物差异均无统计学意义（P>0.05）；治疗后，2组FACT-B评分、CD4⁺、CD4⁺/CD8⁺水平均较治疗前升高（P<0.05），CD8⁺、CA125、CA153、CEA水平较治疗前降低（P<0.05），且联合组各指标变化较奈拉替尼组显著（P<0.05）；治疗期间，联合组不良反应发生率低于奈拉替尼组（P<0.05）。结论曲妥珠单抗联合奈拉替尼治疗HER-2阳性转移性乳腺癌疗效显著，且安全性较高。

关键词: 乳腺肿瘤, 受体，ErbB-2, 曲妥珠单抗, 奈拉替尼, 表皮生长因子受体-2阳性转移性乳腺癌

Abstract:

Objective To investigate the efficacy of trastuzumab combined with neratinib on human epidermal growth factor receptor (HER) -2 positive metastatic breast cancer and its impact in the immune function and quality of life of patients. Methods Eighty-two patients with HER-2 positive metastatic breast cancer admitted to our hospital (from June 2022 to December 2023) were included and used as research objects. Patients were separated into the neratinib group and the combination group stochastically, with 41 cases in each group. The neratinib group was treated with neratinib maleate, and the combined group was treated with trastuzumab for injection on the basis of neratinib group for 6 courses of treatment. The clinical efficacy, quality of life scores (FACT-B), immune function indicators (CD4⁺, CD8⁺, CD4⁺/CD8⁺), tumor marker indicators [carbohydrate antigen (CA) 125, CA153, carcinoembryonic antigen (CEA)] and adverse reactions were observed before treatment and after 6 courses of treatment between two groups. Results The overall clinical symptom relief rate was greatly higher in the combination group than that of the neratinib group (P<0.05). Before treatment, there were no significant differences in quality of life, immune function and tumor markers between the two groups (P>0.05). After treatment, FACT-B score, CD4⁺, CD4⁺/CD8⁺ levels were higher in the two groups than before treatment (P<0.05), while CD8⁺, CA125, CA153 and CEA levels were lower than before treatment (P<0.05), and changes of indexes were more significant in the combination group than those in the nilatinib group (P<0.05). During treatment, the incidence of adverse reactions was lower in the combination group than that in the nilatinib group (P<0.05). Conclusion Trastuzumab combined with neratinib is effective and safe in the treatment of HER-2 positive metastatic breast cancer.

Key words: breast neoplasms, receptor, ErbB-2, Trastuzumab, Neratinib, human epidermal growth factor receptor-2 positive metastatic breast cancer

中图分类号:

R737.9

图/表 6

参考文献 18

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组别	n	年龄/岁	肿瘤直径/cm	转移部位			发病部位		BMI/（kg/m²）
组别	n	年龄/岁	肿瘤直径/cm	肝	肺	其他部位	单侧	双侧	BMI/（kg/m²）
奈拉替尼组	41	54.27±10.23	3.63±0.49	15（36.58）	14（34.15）	12（29.27）	31（75.61）	10（24.39）	22.47±6.72
联合组	41	53.85±9.46	3.59±0.50	17（41.46）	13（31.71）	11（26.83）	28（68.29）	13（31.71）	22.61±7.23
t或χ²		0.191	0.448	0.206			0.544		0.084

组别	n	年龄/岁	肿瘤直径/cm	转移部位			发病部位		BMI/（kg/m²）
组别	n	年龄/岁	肿瘤直径/cm	肝	肺	其他部位	单侧	双侧	BMI/（kg/m²）
奈拉替尼组	41	54.27±10.23	3.63±0.49	15（36.58）	14（34.15）	12（29.27）	31（75.61）	10（24.39）	22.47±6.72
联合组	41	53.85±9.46	3.59±0.50	17（41.46）	13（31.71）	11（26.83）	28（68.29）	13（31.71）	22.61±7.23
t或χ²		0.191	0.448	0.206			0.544		0.084

组别	n	明显缓解	部分缓解	病情加重	总缓解
奈拉替尼组	41	7（17.07）	24（58.54）	10（24.39）	31（75.61）
联合组	41	10（24.39）	28（68.29）	3（7.32）	38（92.68）

组别	n	明显缓解	部分缓解	病情加重	总缓解
奈拉替尼组	41	7（17.07）	24（58.54）	10（24.39）	31（75.61）
联合组	41	10（24.39）	28（68.29）	3（7.32）	38（92.68）

组别	n	FACT-B
组别	n	治疗前	治疗后	t
奈拉替尼组	41	50.63±14.59	82.78±16.74	9.375^＊
联合组	41	52.17±15.32	91.66±18.43	10.985^＊
t		0.465	2.283^＊