曲妥珠单抗辅助治疗对T1N0M0期人表皮生长因子受体2阳性乳腺癌远期生存影响的真实世界研究

Effects of adjuvant trastuzumab on long-term survival of T1N0M0 stage human epidermal growth factor receptor 2 positive breast cancer:a real-world study

目的探讨曲妥珠单抗辅助治疗对人表皮生长因子受体2(HER-2)阳性早期乳腺癌患者预后的影响。方法研究为回顾性研究,选取2010年1月至2019年12月就诊于新疆医科大学附属肿瘤医院并接受手术的HER-2阳性T1N0M0期乳腺癌患者,根据是否接受曲妥珠单抗治疗将患者分为治疗组和对照组。采用倾向性评分匹配(PSM)平衡两组间患者基线特征差异造成的混杂偏倚,Cox比例风险模型分析影响无病生存的危险因素,Kaplan-Meier法估计PSM前后两组患者的3、5年无病生存率和总生存率。结果 HER-2阳性T1N0M0期乳腺癌患者291例,其中T1a期21例(7.2%),T1b期61例(21.0%),T1c期209例(71.8%)。PSM前,治疗组132例,对照组159例,PSM前全组患者的5年无病生存率为88.5%,5年生存率为91.5%。PSM后,治疗组103例,对照组103例,PSM后全组患者的5年无病生存率为86.0%,5年生存率为88.5%。PSM前,治疗组和对照组患者的肿瘤大小、组织学分级、脉管是否侵犯、Ki-67指数、术后是否化疗、术后是否放疗差异均有统计学意义(均P<0.05);PSM后,治疗组和对照组患者的临床病理特征差异无统计学意义(均P>0.05)。多因素分析显示,组织学分级(HR=2.927,95CI:1.476~5.805,P=0.002)、脉管侵犯(HR=3.410,95CI:1.170~9.940,P=0.025)、月经状态(HR=3.692,95CI:1.021~13.344,P=0.046)、是否化疗(HR=0.238,95CI:0.079~0.720,P=0.011)是无病生存的独立影响因素。PSM后,治疗组患者5年无病生存率为89.2%,对照组为83.5%(P=0.237);治疗组患者5年生存率为96.1%,对照组为84.7%(P=0.036)。结论术后曲妥珠单抗靶向治疗可以降低HER-2阳性T1N0M0期乳腺癌患者的复发转移风险。

Objective To investigate the prognosis impact of adjuvant trastuzumab treatment on human epidermal growth factor receptor 2(HER-2)positive early breast cancer patients.Methods A retrospective study was conducted,HER-2-positive T1N0M0 stage breast cancer patients who underwent surgery in the Affiliated Tumor Hospital of Xinjiang Medical University from January 2010 to December 2019 were divided into treatment group and control group according to whether they were treated with trastuzumab or not.Propensity score matching(PSM)was used to balance the confounding bias caused by differences in baseline characteristics between the two groups.Cox proportional hazards model was used to analyze the risk factors affecting disease-free survival(DFS).The Kaplan-Meier method was used to estimate the 3-and 5-year DFS and overall survival(OS)rates of the two groups before and after PSM.Results There were 291 patients with HER-2 positive T1N0M0 stage breast cancer,including 21 cases in T1a(7.2%),61 cases in T1b(21.0%),and 209 cases in T1c(71.8%).Before PSM,there were 132 cases in the treatment group and 159 cases in the control group,the 5-year DFS rate was 88.5%,and the 5-year OS rate was 91.5%.After PSM,there were 103 cases in the treatment group and 103 cases in the control group,the 5-year DFS rate was 86.0%,and the 5-year OS rate was 88.5%.Before PSM,there were significant differences in tumor size,histological grade,vascular invasion,Ki-67 index,postoperative chemotherapy or not and radiotherapy between the treatment group and the control group(P<0.05).After PSM,there were no significant difference in clinicopathological features between the treatment group and the control group(P>0.05).Multivariate analysis showed that histological grade(HR=2.927,95 CI:1.476,5.805;P=0.002),vascular invasion(HR=3.410,95 CI:1.170,9.940;P=0.025),menstrual status(HR=3.692,95 CI:1.021,13.344,P=0.046),and chemotherapy(HR=0.238,95 CI:0.079,0.720;P=0.011)were independent factors affecting DFS.After PSM,the 5-year DFS rate of the treatment group was 89.2%,while that of the control group was 83.5%(P=0.237).The 5-year OS rate of the treatment group was 96.1%,while that of the control group was 84.7%(P=0.036).Conclusion Postoperative targeted therapy with trastuzumab can reduce the risk of recurrence and metastasis in patients with HER-2-positive T1N0M0 stage breast cancer.