Clinical efficacy of comprehensive traditional Chinese medicine in adjuvant therapy for stage Ib-IIIa resected non-small cell lung cancer: a multi-center, randomized, double-blind, placebo-controlled trial.

[BACKGROUND] Recurrence and metastasis after radical resection for non-small cell lung cancer (NSCLC) remain a significant cause of treatment failure. Comprehensive Traditional Chinese Medicine (TCM) has emerged as a vital therapeutic approach in China. This study evaluated the efficacy and safety of TCM treatment with platinum-based adjuvant chemotherapy for patients of stage IB-IIIA resected NSCLC.

[METHODS] A randomised controlled trial was conducted at four centres in Shanghai, China. A total of 286 participants with completely resected (R0) stage IB-IIIA NSCLC were randomly divided in a 1:1 ratio to a TCM treatment group (n = 143) and a control group (n = 143). Which received adjuvant chemotherapy plus TCM granules or placebo granules, for four cycles. And then, followed by four cycles of Huachansu injections. The received in addition to the adjuvant chemotherapy, followed by placebo injections.

[RESULTS] ITT analysis was concluded with 286 patients. 2-year disease-free survival (DFS) rate (95% Confidence Interval [CI]) was 65.70% (57.86, 73.54) in the TCM treatment group and was 55.4% (47.17, 63.63) in the control group, the difference was not statistically significant, but a trend was observed (p = 0.08). A significantly prolonged DFS in the TCM group was revealed in contrast to the control group (37.8 months vs. 31.6 months, Hazard Ratio [HR], 0.73; 95% CI 0.579, 0.995; p = 0.045). TCM granules significantly improved lung cancer-related symptoms including fatigue, pain, dyspnea, insomnia, cough, chest pain and diarrhea, and promote physical function, emotional function and overall health. No unexpected treatment-related adverse events were observed in both groups.

[CONCLUSION] Comprehensive Traditional Chinese Medicine treatment combined with chemotherapy-based adjuvant therapy have a positive impact on DFS and improved quality of life in NSCLC patients. These findings suggested that TCM can be used as one of the adjuvant therapies following unselected radical resection in Chinese patients with stage IB-IIIA NSCLC.

[CLINICAL TRIAL REGISTRATION] https://www.chictr.org.cn/, identifier ChiCTR-IPR-16009062.