A double-blind and randomized controlled clinical trial of traditional Chinese medicine combined with adjuvant chemotherapy for early stage non-small cell lung cancer

Abstract

Objective To evaluate the efficacy of adjuvant chemotherapy combined with traditional Chinese medicine (TCM) on the prevention of the radical resected non-small cell lung cancer (NSCLC) relapse and metastasis. Methods A double-blind and randomized controlled clinical trial including 100 patients with radical resected NSCLC enrolled was designed. The subjects were randomly divided into two groups, adjuvant chemotherapy group combine with placebo (control group) and adjuvant chemotherapy combined with TCM group (trial group). 4 cycles of adjuvant chemotherapy [NC regimen: vinorelbine 25 mg/m2, d1 and d8 combined with carboplatin AUC = 5 mg/(ml·min), d1] were used after surgery. The curve of disease free survival (DFS) was drew by Kaplan-Meier test. Two groups' curative effects were compared by repeated measurement of quality of life (QOL) score and TCM symptom score before, during and after treatment. Results The median DFS of trail group was longer than that of control group (36.00 months vs 23.98 months, P = 0.047). Stratification analysis showed that DFS of trial group was longer than that of control group for the Ⅰ-Ⅱ stage patients (35.32 months vs 28.82 months, P = 0.037), and DFSs of both groups for patients in ⅢA stage were no difference (P = 0.555). TCM symptom complex score of the trail group was decreased after treatment and had a significantly statistical difference (P = 0.022). Cox multivariate analysis showed that the tumor stage was the main influence factor of DFS (P = 0.000). Physical function, role function, emotional function, and overall health status were significantly improved after treatment (P < 0.05). In the related symptoms, fatigue, pain, insomnia were gradually improved with the extension of treatment time and the implementation of the supplementary treatment, but there was no significant difference in the QOL between the two groups. In the trail group, there were 8 cases of adverse events, which was less than that in the control group (14 cases) (P = 0.045). Conclusion Adjuvant chemotherapy combined with TCM can prolong the DFS of patients with radical resected NSCLC, reduce recurrence rate, relieve the adverse effects of chemotherapy, and improve the clinical and Chinese medical symptoms. Key words: Carcinoma, non-small-cell lung; Postoperative adjuvant chemotherapy; Adjuvant chemotherapy combined with traditional Chinese medicine; Disease-free survival; Quality of life; Chinese medicine symptom