Objective:

2

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).

Methods:

2

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.

Results:

2

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 Ⅱ–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.

Conclusions:

2

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)