| Lots of clinical studies of high quality have been proved that maintenance therapy is important in treating Non-Small-Cell Lung Cancer. To date, the most common mainly drugs provided in NSCLC maintenance treatment are chemotherapy and tyrosine kinase inhibitors (TKIs). However, chemotherapy drugs usually lead to variety of side-effects, like gastrointestinal reactions, bone-marrow suppression and so on. The use of EGFR-TKIs requires specific type of EGFR gene. Further more, EGFR-TKIs is of high cost. All the problems of the maintenance treatment right now reduce patients’willing of intention to maintenance treatment. Besides, studies on drugs of maintenance therapy haven’ t been distinguished EGFR mutation and wild-typed EGFR. Traditional Chinese Medicine has been used in oncology for many years. Many clinical studies have been proved that Traditional Chinese Medicine has the effect of reducing toxicity, enhancing potency of chemotherapy and prolonging thesurvival. However, most of the clinical trials on Chinese Medicine are of poor quality and own small sample size.which results in the uncertain efficacy of Chinese Medicine. Overall, evidence of the effect of Traditional Chinese Medicine still lacks of science and reliability. Either single S-1 or Xiaoji Decoction has been proved to be effective as maintenance therapy in NSCLC patients, while the effect of S-1 plus Xiaoji decoction have not been known. Aiming to solve the existed problems of NSCLC maintenance therapy at the moment and the Chinese Medicine are facing in NSCLC, we conduct this study. This study also aims to evaluate whether advanced NSCLC patients with wild-typed EGFR can benefit from S-1 plus Xiaoji decoction or not. Purpose1. Meta-analysis on the influence of Chinese Medicine as maintenance therapy in PFS and quality of life(QOL)in advanced NSCLC patients:Aiming to provide reliable and scientific clinical use of Traditional Chinese Medicine as maintenance treatment, we conduct a meta-analysis on the literature 2006-2016 on the effect of chinese medicine as maintenance therapy.2. Clinical study on S-1 plus Xiaoji decoction in maintenance therapy on stage ⅢB/Ⅳ in NSCLC patients with wt-EGFR:The effect of S-1 combined with Xiaoji decoction hasn’t been known. To observe combined effect between these two drugs with the hope that finding a new treating method to NSCLC maintenance treatment, we conduct this study.Method1. Meta-analysis on the influence of Chinese Medicine as maintenance therapy in PFS and QOL in advanced NSCLC patients:According to the severe included/excluded criteria,we search the CNKI, SinoMed, WanFang, VIP, PubMed Cochrane library and EBASE database for literature 2006.01-2016.03. After collecting appropriate papers, we make comments to these studies through Cochrane criteria and conduct the meta-analysis. The endpoints are PFS and QOL(EORTC-QLQ-C30 Score, KPS Score).2. Clinical study on S-1 plus Xiaoji decoction in maintenance therapy on stage ⅢB/Ⅳ in NSCLC patients with wt-EGFR:29 patients harboring wt-EGFR with stage ⅢB/Ⅳ NSCLC were randomly allocated to two groups,one is single S-1 group and the other is Xiaoji decoction plus S-1 group. The outcome parameters are PFS and QOL(EORTC-QLQ-LC43 Score, FACT-L Score). Result1. Meta-analysis on the influence of Traditional Chinese Medicine in PFS and quality of life in maintenance therapy in NSCLC:21 studies have been included with 1426 patients.20 studies are of Class B and 1 study is of Class C through Cochrane criteria. PFS is presented with x±s in 8 studies. After analyzing the 8 studies, x2 is 104.56 (P＜0.00001,I2=93%) for heterogeneity test. Effect size of SMD is 2.89(95%CI:2.00-3.78), Z is 6.38 (P＜0.00001). All the outcomes prove that using chinese medicine as maintenance therapy in advanced NSCLC patients can prolong PFS. Although the heterogeneity is high, it also proves that the result above is of clinical value and reliability. Also, it indicates that Traditional Chinese Medicine improves NSCLC patients’quality of life(P＜0.01).2. Clinical study on S-1 plus Xiaoji decoction in maintenance therapy on stage IIIB/IV in NSCLC patients with wt-EGFR:There is no statistical difference between two groups in PFS (3.81+0.85months vs 2.34+0.31months, x2=3.08, P＞0.05). Comparing with the single S-1 group,it shows a 1.47-month extension in the combined group, which may indicates a trend that advanced NSCLC patients may benefit from the combined therapy as maintenance treatment. For quality of life,the difference is statistically significant between two groups (P＞0.05).Conclusion:1. Meta-analysis on the influence of Chinese medicine in PFS and quality of life in maintenance therapy in NSCLC:Traditional Chinese Medicine as maintenance therapy has the effect of prolonging PFS and improving subjects’ quality of life with less adverse effects in NSCLC patients. The quality of the literature included in this systematic review are not high and the sample size of them are small, it needs more randomized clinical trial who are of high quality and owns big sample size to support the conclusion above.2. Clinical study on S-1 plus Xiaoji decoction in maintenance therapy on stage IIIB/IV in NSCLC patients with wt-EGFR:As the sample size of the trial is small,which may results in false-positive or false-negative results.It needs trials of big sample size to further study. |
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