摘要Objective:To investigate whether the combination of chemotherapy with staged Chinese herbal medicine(CHM)therapy could enhance health-related quality of life(QoL)in non-small-cell lung cancer(NSCLC)patients and prolong the time before deterioration of lung cancer symptoms,in comparison to chemotherapy alone.Methods:A prospective,double-blind,randomized,controlled trial was conducted from December 14,2017 to August 28,2020.A total of 180 patients with stage Ⅰ B-ⅢA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM(chemo+CHM)group(120 cases)or chemotherapy combined with placebo(chemo+placebo)group(60 cases)using stratified blocking randomization.The European Organization for Research and Treatment of Cancer(EORTC)Quality-of-Life-Core 30 Scale(QLQ-C30)was used to evaluate the patient-reported outcomes(PROs)during postoperative adjuvant chemotherapy in patients with early-stage NSCLC.Adverse events(AEs)were assessed in the safety analysis.Results:Out of the total 180 patients,173 patients(116 in the chemo+CHM group and 57 in the chemo+placebo group)were included in the PRO analyses.The initial mean QLQ-C30 Global Health Status(GHS)/QoL scores at baseline were 57.16±1.64 and 57.67±2.25 for the two respective groups(P＞0.05).Compared with baseline,the chemo+CHM group had an improvement in QLQ-C30 GHS/QoL score at week 18[least squares mean(LSM)change 17.83,95％confidence interval(CI)14.29 to 21.38].Conversely,the chemo+placebo group had a decrease in the score(LSM change-13.67,95％CI-22.70 to-4.63).A significant between-group difference in the LSM GHS/QoL score was observed,amounting to 31.63 points(95％CI 25.61 to 37.64,P＜0.001).The similar trends were observed in physical functioning,fatigue and appetite loss.At week 18,patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group(P＜0.001).The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score[hazard ratio(HR)=0.33,95％CI 0.23 to 0.48,P＜0.0010],physical functioning(HR=0.43,95％CI 0.25 to 0.75,P=0.0005),fatigue(HR=0.47,95％CI 0.30 to 0.72,P＜0.0001)and appetite loss(HR=0.65,95％CI 0.42 to 1.00,P=0.0215).The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group(9.83％vs.15.79％,P=0.52).Conclusion:The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy,which is worthy of further clinical research.(Registry No.NCT03372694)