Abstract
BackgroundThe toxicity and side effects caused by adjuvant chemotherapy (ACT) after radical surgery for lung adenocarcinoma (LAC) lead to early termination frequently. This study was conducted to provide an objective basis for the effect of Chinese herbal medicine formulas (CHMFs) combined with chemotherapy in reducing toxicity and enhancing efficacy of ACT.MethodFrom February 17th, 2012 to March 20th, 2015, 233 patients from 7 hospitals diagnosed with LAC in IB~IIIA stage were randomly assigned into ACT + CHMF group (116 patients) and ACT + placebo group (117 patients). CHMF was taken orally until the end of chemotherapy. Chemotherapy-related toxic, side effects were investigated as the primary outcome. Disease-free survival (DFS) and overall survival (OS) were used as the secondary outcome.ResultsAt one week following chemotherapy, the incidence of dry mouth, diarrhea and thrombocytopenia significantly decreased in CHMF group (P = 0.017, P = 0.033, P = 0.019, respectively). At two weeks following chemotherapy, fatigue and diarrhea were more obvious in the placebo group (P = 0.028, P = 0.025, respectively). In addition, patients in the CHMF group showed an increase in median DFS from 37.1 to 51.5 months compared with placebo group although there was no statistical significance (P = 0.16). In the stage IB subgroup, the CHMF group had a significantly better DFS (HR (95% CI) = 0.53 (0.28–0.99), P = 0.046). There was no significant difference in OS between the groups (P = 0.72).ConclusionFor patients with LAC, ACT combined with CHMF after radical surgery can prolong the DFS time especially in the early stage, and reduces the chemotherapy-related toxic and side effects.Trial RegistrationNCT 01441752. Registered 14 July, 2011.
Highlights
The toxicity and side effects caused by adjuvant chemotherapy (ACT) after radical surgery for lung adenocarcinoma (LAC) lead to early termination frequently
Patients in the Chinese herbal medicine formulas (CHMFs) group showed an increase in median Disease-free survival (DFS) from 37.1 to 51.5 months compared with placebo group there was no statistical significance (P = 0.16)
For patients with LAC, ACT combined with CHMF after radical surgery can prolong the DFS time especially in the early stage, and reduces the chemotherapy-related toxic and side effects
Summary
The toxicity and side effects caused by adjuvant chemotherapy (ACT) after radical surgery for lung adenocarcinoma (LAC) lead to early termination frequently. The 5-year survival rate was 5.4% higher in the cisplatin-based ACT group than in the group receiving no ACT Another trial by Adjuvant Navelbine International Trialist Association (ANITA) showed the survival benefit of adjuvant vinorelbine plus cisplatin (NP) versus control in patients with completely resected stage IB~IIIA NSCLC. Based on results from these studies and relevant analyses, the guidelines issued by American Society of Clinical Oncology (ASCO) and U.S National Comprehensive Cancer Network (NCCN) recommend that cisplatin-based two drugs ACT be given to post-surgical NSCLC patients suffering from resectable stage II~IIIA NSCLC or stage IB NSCLC with high risk factors [5, 6]
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