Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Department of Oncology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510000, China.
Chin J Integr Med. 2019 Nov;25(11):812-819. doi: 10.1007/s11655-019-3168-6. Epub 2019 Aug 31.
To evaluate the association between Chinese medicine (CM) therapy and disease-free survival (DFS) outcomes in postoperative patients with non-small cell lung cancer (NSCLC).
This multiple-center prospective cohort study was conducted in 13 medical centers in China. Patients with stage I, II, or IIIA NSCLC who had undergone radical resection and received conventional postoperative treatment according to the National Comprehensive Cancer Network (NCCN) guidelines were recruited. The recruited patients were divided into a CM treatment group and a control group according to their wishes. Patients in the CM treatment group received continuous CM therapy for more than 6 months or until disease progression. Patients in the control group received CM therapy for less than 1 month. Follow-up was conducted over 3 years. The primary outcome was DFS, with recurrence/metastasis rates as a secondary outcome.
Between May 2013 and August 2016, 503 patients were enrolled into the cohort; 266 were classified in the CM treatment group and 237 in the control group. Adjusting for covariates, high exposure to CM was associated with better DFS [hazard ratio (HR) = 0.417, 95% confidential interval (CI): 0.307-0.567)]. A longer duration of CM therapy (6-12 months, 12-18 months, >24 months) was associated with lower recurrence and metastasis rates (HR = 0.225, 0.119 and 0.083, respectively). In a subgroup exploratory analysis, CM therapy was also a protective factor of cancer recurrence and metastasis in both stage I-IIIA (HR=0.50, 95% CI: 0.37-0.67) and stage IIIA NSCLC postoperative patients (HR = 0.48, 95% CI: 0.33-0.71), DFS was even longer among CM treatment group patients.
Longer duration of CM therapy could be considered a protective factor of cancer recurrence and metastasis. CM treatment is associated with improving survival outcomes of postoperative NSCLC patients in China. (Registration No. ChiCTR-OOC-14005398).
评估中医药治疗与非小细胞肺癌（NSCLC）术后无病生存（DFS）结局之间的关联。
本多中心前瞻性队列研究在中国 13 家医疗中心进行。招募了接受根治性切除术且根据国家综合癌症网络（NCCN）指南接受常规术后治疗的 I 期、II 期或 IIIA 期 NSCLC 患者。根据患者意愿，将招募的患者分为中医药治疗组和对照组。中医药治疗组患者接受连续中医药治疗超过 6 个月或直至疾病进展。对照组患者接受中医药治疗少于 1 个月。随访时间为 3 年。主要结局为 DFS，次要结局为复发/转移率。
2013 年 5 月至 2016 年 8 月，503 例患者入组该队列；266 例患者被归类为中医药治疗组，237 例患者被归类为对照组。调整混杂因素后，高中医药暴露与更好的 DFS 相关[风险比（HR）=0.417，95%置信区间（CI）：0.307-0.567]。中医药治疗时间（6-12 个月、12-18 个月、>24 个月）较长与较低的复发和转移率相关（HR=0.225、0.119 和 0.083）。在亚组探索性分析中，中医药治疗也是 I 期-IIIA 期（HR=0.50，95%CI：0.37-0.67）和 IIIA 期 NSCLC 术后患者癌症复发和转移的保护因素（HR=0.48，95%CI：0.33-0.71），中医药治疗组患者的 DFS 更长。
中医药治疗时间较长可被视为癌症复发和转移的保护因素。中医药治疗与改善中国 NSCLC 术后患者的生存结局相关。（注册号 ChiCTR-OOC-14005398）。
