高暴露中药治疗对三阴性乳腺癌术后生存的影响

Postoperative Survival of Triple Negative Breast Cancer Patients After High Exposure to Traditional Chinese Medicine:A Cohort Study

目的:评价高暴露中药治疗对三阴性乳腺癌(TNBC)术后患者3年生存期的影响。方法:回顾分析3年随访资料完整的150例Ⅰ~Ⅲ期TNBC术后患者临床资料,所有患者均按美国国立综合癌症网络(NCCN)临床指南经西医常规治疗[手术、化疗和(或)放疗],以规律中医药治疗为暴露因素,分为高暴露中药治疗、低暴露中药治疗2个队列,高暴露中药组以每年口服柴胡龙牡汤加或不加抗肿瘤中成药≥6个月或累积18个月及以上为条件,观察2个队列复发转移部位和复发转移/死亡时间,比较2个队列无病生存期(DFS)和总生存期(OS)差异,统计分析患者发病年龄、病理类型、病理组织学分级、脉管浸润状态、临床分期及中药暴露因素对生存期的影响,观察相关不良反应。结果:两组复发转移部位比较差异无统计学意义;高暴露组3年DFS长于低暴露组,且高暴露组较低暴露组3年无病生存率提高16.9%(χ^(2)=6.995,P=0.008),差异有统计学意义(P<0.05);Cox回归风险模型显示,低暴露组患者复发转移风险为高暴露组的3.724倍(95%CI 1.399~9.915);两组3年OS比较差异无统计学意义;两组总体不良反应发生率7.3%,主要表现在胃肠道不适。结论:高暴露中医药治疗在减少三阴性乳腺癌术后复发转移、延长无病生存期上有较好优势。

Objective:To evaluate the 3-year survival outcomes of postoperative patients after high exposure to traditional Chinese medicine(TCM)for triple negative breast cancer(TNBC).Method:The complete 3-year follow-up data of 150 postoperative patients with stage I–III TNBC were retrospectively analyzed.All the patients received routine western medical treatments(surgery,chemotherapy,and/or radiotherapy)according to the National Comprehensive Cancer Network(NCCN)clinical practice guidelines in oncology as well as TCM.According to the degree of exposure to TCM,they were divided into the high-and low-exposure cohorts,with the oral administration of Chaihu Longmu Decoction with or without anti-cancer Chinese patent medicine for at least six months annually,or 18 months or more in the three years as the inclusion criterion for the former cohort.The metastatic sites of recurrent TNBC and the recurrent metastasis/death time were observed in both cohorts to compare the disease-free survival(DFS)and overall survival(OS).The influences of onset age,pathological type,histopathological grade,vascular invasion,clinical stage,and exposure to TCM on survival were subjected to statistical analysis,followed by the observation of adverse effects.Result:There was no significant difference in the metastatic sites between the two cohorts(P>0.05).The high-exposure cohort had a longer 3-year DFS than the low-exposure cohort,and the 3-year DFS rate in the high-exposure cohort was increased by 16.9%(χ^(2)=6.995,P=0.008)as compared with that in the low-exposure cohort,exhibiting a significant difference(P<0.05).As revealed by the Cox proportional-hazards model,patients in the low-exposure cohort had a 3.724-fold as high risk of recurrent metastasis as that in the highexposure cohort(95%CI 1.399~9.915).There was no significant difference in the 3-year OS between the two cohorts(P>0.05).The overall incidence of adverse effects in both groups was 7.3%,mainly manifested as gastrointestinal discomfort.Conclusion:High exposure to TCM contributes to reducing postoperative recurrence and metastasis and prolonging DFS.