伊尼妥单抗治疗晚期乳腺癌的真实世界研究

A real-world study on the efficacy and safety of inetetamab in the treatment of advanced breast cancer

目的 观察真实世界中伊尼妥单抗治疗晚期乳腺癌的疗效和安全性。方法 回顾性分析2020年8月至2022年8月就诊于襄阳市中心医院并接受伊尼妥单抗治疗的63例晚期乳腺癌患者的临床资料。生存分析采用Kaplan-Meier法绘制生存曲线并进行Log-rank检验,采用Cox比例风险回归模型分析影响预后的危险因素,采用非参数检验Kruskal-Wallis分析不同亚组间治疗疗效的差异。结果 63例患者的客观缓解率(ORR)为47.6%(30/63),疾病控制率(DCR)为66.7%(42/63)。伊尼妥单抗一线至二线治疗患者的ORR、DCR分别为85.0%、90.0%,三线至七线治疗患者的ORR、DCR分别为30.2%、55.8%,两组比较差异有统计学意义(P<0.05)。既往使用过曲妥珠单抗和酪氨酸激酶抑制剂(TKI)药物的患者ORR、DCR分别为31.0%、 54.8%,既往未使用过曲妥珠单抗和TKI药物的患者ORR、DCR分别为81.0%、90.5%,两组比较差异有统计学意义(P<0.05)。全体患者的中位无进展生存期(PFS)为5个月。单因素分析显示,伊尼妥单抗治疗线数、转移部位数、既往曲妥珠单抗和TKI药物使用情况及近期疗效均与患者预后有关(P<0.05)。多因素Cox回归分析显示,近期疗效是影响患者预后的独立因素(P<0.05)。3~4级不良反应的发生率为9.5%(6/63),其中血小板减少1例、贫血1例、肾功能不全2例、腹泻2例。结论 伊尼妥单抗治疗晚期乳腺癌疗效确切,不良反应可控,具有较好的临床应用价值。

Objective To observe the efficacy and safety of inetetamab in the treatment of advanced breast cancer in the real-world.Methods A retrospective analysis was performed on 63 patients with advanced breast cancer admitted to Xiangyang Central Hospital from August 2020 to August 2022.Survival curve was plotted by Kaplan-Meier method and performed with Log-rank test.Cox proportional risk model was used to analyze the risk factors affecting the prognosis,and non-parametric test Kruskal-Wallis was used to analyze the difference in treatment efficacy among different subgroups.Results The objective response rate(ORR)of 63 patients was 47.6%(30/63),and the disease control rate(DCR)was 66.7%(42/63).The ORR and DCR of the patients treated with first-line and second-line inetetamab were 85.0%and 90.0%,and those treated with third-line to seventh-line inetetamab were 30.2%and 55.8%,respectively,and the difference between the two groups was statistically significant(P<0.05).The ORR and DCR of patients who had previously used trastuzumab and tyrosine kinase inhibitor(TKI)were 31.0%and 54.8%,respectively,and those who had not used trastuzumab and TKI before were 81.0%and 90.5%,respectively,and the difference between the two groups was statistically significant(P<0.05).The median progression-free survival(PFS)for all patients was 5 months.Univariate analysis showed that the number of treatment lines,number of metastatic sites,previous use of trastuzumab and TKI drugs,and efficacy were all related to prognosis(P<0.05).Multivariate analysis showed that efficacy evaluation was an independent prognostic factor(P<0.05).The incidence of grade 3-4 adverse reactions was 9.5%(6/63),including 1 case of thrombocytopenia,1 case of anemia,2 cases of renal insufficiency,and 2 cases of diarrhea.Conclusion The efficacy of inetetamab in the treatment of advanced breast cancer is definite,and the adverse reactions are controllable,which has good clinical application value.