Shenyi capsule prolongs postoperative survival of patients with nonsmall cell lung cancer: A multicenter, randomized, controlled trial

Abstract

Objective: The objective of this study was to examine the effect of the postsurgical administration of Shenyi capsules on the outcome and overall survival of patients with nonsmall cell lung cancer (NSCLC). Materials and Methods: This was a multicenter, randomized, placebo-controlled, double-blind clinical trial. Patients with stages I–IIIA NSCLC were randomized to Shenyi or placebo groups (treatment duration: 6 months) and followed up for 10 years. One-year, 2-year, 5-year, and 10-year survival rates and survival times were calculated. Symptoms, quality of life, traditional Chinese medicine (TCM) syndrome, and recurrence were evaluated. Results: A total of 361 patients (treatment group, n = 185; placebo group, n = 176) were randomized and followed up for 10 years. The two groups had similar baseline demographic and clinical characteristics. Among all 361 patients, the treatment group had significantly longer median survival (31 months, respectively) than the placebo group (22.3 months, P < 0.01). In stage II or III patients, recurrence and metastasis rates in the treatment group were lower than those in the placebo group (P < 0.05). The treatment group also had significantly longer 1-year and 2-year survival rates based on the full analysis set and per-protocol set; however, there was no statistically significant difference in the 5-year and 10-year survival rates (P < 0.01 for all comparisons). Multivariate analysis of variance showed that the interaction between stage and age had a significant impact on overall survival (P < 0.05). Compared with the placebo group, the treatment group showed a significant decrease in TCM syndrome (P < 0.01) and a significant increase in the Karnofsky Performance Score (P < 0.01) and body weight (P < 0.05). Conclusions: Adjunctive therapy with Shenyi capsules significantly prolonged the 1-year and 2-year survival rates after surgery and improved the quality of life. Moreover, none of the patients experienced severe adverse effects. These results suggest that Shenyi capsules may have clinical applications in treating patients with NSCLC.