Clinical Observation Of Decoction For Invigorating The Spleen Binding TF Program For Advanced Gastric Cancer

Objective: The incidence of gastric cancer is in the fourth place among all the malignant tumors worldwide, and the mortality rate is in the second place. But in many regions of China, the morbidity and mortality of gastric cancer is in the first place. Due to the low rate of early diagnosis, most of the clinical diagnosis of gastric cancer is in the advanced stage. The preferred treatment of gastric cancer is surgical resection. However, about 40% of patients lost the opportunities of surgery because of the late stage of the cancer; about 50% of gastric cancer patients appeared recurrence and metastasis after radical resection. The prognosis of advanced gastric cancer is poor, and the meso survival time is about 3 to 5 months if the patients only adopt support the treatment. There is no sufficient evidence to support that the postoperative adjuvant chemotherapy is benefit for gastric cancer survival, and the best first-line chemotherapy program for advanced gastric cancer is still undetermined. Many randomized clinical trial found that chemotherapy prolong the median survival time from 3~5 months to 7.5~l2 months compared with best supportive care. Chemotherapy can prolong the patients'life span but induce disadvantage and adverse effect at different level during the process of controlling progression of tumor. The traditional Chinese medicine may increase the chemotherapeutic efficacy, improve survival time and reduce the side effects of chemotherapy. The purpose of this paper is to explore the effect of combination of TF and decoction for invigorating the spleen for the treatment of advanced gastric cancers on the aspect of improving the short-term effect, extending the survival time and reducing the adverse effects of chemotherapy.Methods:The data of 72 cases of pathologically confirmed stageⅣgastric cancer from July, 2006 to Dec, 2008 were collected in the Oncological Department of Second Affiliated Hospital of Dalian Medical University and were randomly divided into treatment group and control group. The treatment group adopt the chemotherapy of TF (PTX +5 -Fu + CF, Paclitaxel +5- fluorouracil + calcium folinate) combined with decoction for invigorating the spleen treatment. The essential components of decoction for invigorating the spleen are dangshen 20g, Atractylodes macrocephala 15g, Radix Astragali 25g, Licorice 10g, Poria 20g, Polygala 10g , speculation semen ziziphi spinosae 15g, longan meat 10g, Chinese angelica 10g, Radix 10g, jujube 10g. The decoction for invigorating the spleen was adopted during chemotherapy and during the intermission of chemotherapy, the decoction was used as main prescription. according to the pathological base, the patient with qi-stagnancy and blood stasis added drugs of removing blood and stasis, such as curcumae, radix and curcumae etc.; the patient with phlegmatic hygrosis and thick libngual fur added drugs of invigorating the spleen, dehygrosis and apophlegmatisant such as Coix lacryma and snakegourd fruit etc.; the patient with pyretic toxicity added drugs of heat-clearing and detoxicating, such as scutellaria barbata, lophatherum herb, etc.; the patient with fluid in stomach deficiency added drugs of ophiopogonis tuber, root of straight ladybell, etc.; the patient with abdominal pain and qi-stagnancy added drugs of bupleurum chinense, ructus meliae toosendan etc.. The course of decoction for invigorating the spleen treatment was 2 months to 28 months. TF specific medication program: PTX: 90 mg / m2 intravenous infusion on the 1st and 8th days; CF: 200mg intravenous infusion on the first 1-2 days; 5-Fu: 400 mg /㎡.d intravenous injection, 600 mg /㎡.d 22 hours continuous infusion on the first 1～2 days. Every 21 days was 1 cycle. The control group adopted chemotherapy with TF program. The short-term effect, survival time and the incidence of adverse reactions of the two groups were comparative observed. Clinical efficacy was objectively evaluated according to the RECIST criteria (Response Evaluation Criteria In Solid Tumors) and the adverse reactions were evaluated with the Common Terminology Criteria for Adverse Events v3.0 (CTCAE3.0) of anticancer drug in acute and subacute toxicity in United States National Cancer Institute (NCI). SPSS13.0 statistical software was adopted with X2 test to analyze the efficiency of the two groups and the Kaplan-Meier and Log-rank test to analyze survival time, P<0.05 showed statistical significance.Results:1. The therapeutic effects of 72 cases of advanced gastric cancers were evaluated by RECIST criteria. The efficiency was 42% and 35.2% in the treatment group and control group. There is no significant statistical difference between the two groups (P>0.05) although the short-term efficacy of the treatment group was better than that of the control group.2. Among the 72 cases of advanced gastric cancer patients, 70 cases were evaluable in the median survival time, of which 37 cases of treatment group with the average survival period of 11 months and 1-year survival rate of 39.5%; and 33 cases of control group, the average survival period of 9 months, 1-year survival rate of 26.5%. The survival time of the treatment group showed significant advantage than that of the control group (P <0.05).3. The main adverse reactions of treatment group were myelo- suppression, nausea and vomiting. Among the bone marrow suppression cases, 47% were degreeⅠ, 42% were degreeⅡand 11% were degreeⅢ+Ⅳ; for nausea and vomiting cases, most were degreeⅠ, accounting for 72%, 23% were degreeⅡ, and 5% were degreeⅢ+Ⅳ. The main adverse reactions of control group were similar with the treatment group, but more severe. Among the bone marrow suppression cases, 38% were degreeⅠ, 32% were degreeⅡand 30% were degreeⅢ+Ⅳ; for nausea and vomiting cases, 53% were degreeⅠ, 26% were degreeⅡand 21% were degreeⅢ+Ⅳ. The significant statistical difference could be established between the two groups (P <0.05).Conclusion:1. The combination treatment of TF program and decoction for invigorating the spleen demonstrates a survival advantage to extend survival time compared with separate application of program TF.2. The combination treatment of TF program and decoction for invigorating the spleen showed well tolerance in the treatment of advanced gastric cancer. The main adverse reactions were myelosuppression, nausea and vomiting, most of which wereⅠ~Ⅱdegrees that easy to control and presenting advantages in mitigating the adverse effects of chemotherapy.