摘要
目的 基于真实世界评价中药不同暴露程度对转移性结直肠癌(metastatic colorectal cancer,mCRC)三线治疗生存期的影响.方法 采用多中心、非随机同期对照研究方法,将接受三线治疗的转移性结直肠癌患者分为中西医结合组及西医组进行研究,并以是否在进入三线治疗前服用6个月以上中药作为分层条件,将中西医结合组患者分为高暴露组及低暴露组.对西医组、中西医结合组及高低暴露组分别并使用Kaplan-Meier法估算三线中位生存期,并使用Log Rank检验对预后因素组间生存分布差异进行分析,并将变量应用Cox回归模型进行多因素分析.结果 中西医结合组的三线中位总生存期(Overall survival,OS)为13.1个月,较西医组的9.1个月显著延长(P = 0.009),但两者三线中位无进展生存期(Progression Free Survival,PFS)差异无明显统计学意义(P = 0.062).进一步对高低暴露组进行分层统计,在三线PFS方面,高暴露中医药治疗(三线治疗前中药治疗大于6个月)是三线中位PFS的独立保护因素,HR值为0.491(95%CI:0.315～0766),较低暴露中医药治疗及单纯西医治疗能明显延长患者三线PFS(6.9个月vs 3.533个月vs 3.500个月,P＜0.001,P = 0.001).在三线OS方面,西医组三线OS为9.1个月,低暴露组三线OS为11.167个月,与西医组比较差异不明显(P = 0.055),高暴露组三线OS为14.6个月,较西医组生存期明显延长(P = 0.001),多因素分析显示,高低暴露中医药治疗均为三线OS的独立保护因素[HR=0.450,(95%CI:0.271～0.749);HR=0.579,(95%CI:0.346～0.968)].结论 中药是影响mCRC患者三线预后的独立保护性因素,且三线治疗前中药治疗大于6个月且继续治疗可以延长转移性结直肠癌患者三线无进展生存期及三线总生存期.
Abstract
Objective To evaluate the effect of different exposure levels of traditional Chinese medicine(TCM)on the survival of patients with metastatic colorectal cancer(mCRC)after third-line treatment based on the real world.Methods A multicenter,non-randomized,concurrent controlled study was conducted.Patients with mCRC receiving third-line treatment were divided into integrated traditional Chinese and western medicine group and western medicine group.According to whether they took TCM for more than 6 months before third-line treatment or not,the integrated traditional Chinese and western medicine group was divided into high exposure group and low exposure group.The Kaplan-Meier method was used to estimate the median survival time of the third-line treatment for western medicine group,integrated traditional Chinese and western medicine group as well as the high and low exposure groups,respectively.Log Rank test was used to analyze the difference of survival distribution among the prognostic factors,and Cox regression model was used for multivariate analysis.Results The median overall survival(OS)of third-line treatment in the integrated traditional Chinese and Western medicine group was 13.1 months,which was significantly longer than 9.1 months in the western medicine group(P = 0.009),but there was no significant statistical difference in the median progression free survival(PFS)of third-line treatment between the two groups(P = 0.062).Further stratified statistics of the high and low exposure groups showed that in terms of the PFS of third-line treatment,the high exposure of TCM treatment(TCM treatment for more than 6 months before third-line treatment)was an independent protective factor,with HR of 0.491(95%CI:0.315～0766),and could significantly prolong the PFS of third-line treatment compared to the low exposure of TCM treatment and western medicine(6.9 months vs 3.533 months vs 3.500,P＜0.001,P = 0.001).In terms of the OS of third-line treatment,the western medicine group was 9.1 months while the low exposure group was 11.167 months,and there was no significant difference(P = 0.055).The OS of third-line treatment in the high exposure group was 14.6 months,which had significantly longer survival time than the western medicine group(P = 0.001).Multifactor analysis showed that both high and low exposure group of TCM treatment were independent protective factors for the OS of third-line treatment[HR=0.450,(95%CI:0.271～0.749);HR= 0.579,(95%CI:0.346～0.968)].Conclusion TCM is an independent protective factor for the prognosis of third-line treatment in mCRC patients,and TCM treatment for more than 6 months before third-line treatment can prolong the PFS and OS of third-line treatment in patients with metastatic colorectal cancer.
基金项目
上海市中医肿瘤临床医学研究中心(21MC1930500)
上海市临床重点专科建设项目(中医肿瘤)(shslczdzk03701)
维普
万方数据