Comparison Of Chemotherapy And Cinobufotalin For Elderly Advanced Non-Small Cell Lung Cancer

Objective:Lung cancer,included 80 percent of non-small cell lung cancer(NSCLC), is one of the major causes of malignant tumors-associated death, the morbidity and mortality of lung cancer trend to ascend straightly in china.In NSCLC patients,most patients at the time of diagnosis were at advanced stage and lost the opportunity of surgical therapy.Chemotherapy plays an important part in the whole therapy of advanced NSCLC. However NSCLC is not insensitive to chemotherapy ,the advanced stage elderly NSCLC received little benefit from the present chemotherapy.even the target drug such as Iressa,ect couldn't change the puzzling therapy of advanced NSCLC.Cinobufotalin is a popular anti-tumor drug with little adverse reaction in Traditional Chinese Medicine,which effective and markedly inhibited tumor cell growth,and widely used in clinic.This study was designed to evaluate median survival time and quality of life for the patients with stage III/IV elderly NSCLC by chemotherapy and cino- bufotalin.So as to search the optimal treatment strategy for elderly patients with advanced NSCLC.Methods: The prospective trial was performed in the oncology department of the 1st affiliated hospital of DaLian Medical University. During August 2006 and March 2008. 60 patients with a histologically confirmed diagnosis of stage III/IV NSCLC were enrolled. They were randomly divided into two groups. Therein,30 patients receive treatment of cinobufotalin ,30 patients receive chemotherapy. Project for the cino- bufotalin group: with cinobufacini injection 20ml into 5%GS/NS 500ml intravenous drip, once daily,continued for 4 weeks per course,stoping other therapy in the period of treatment such as other Traditional Chinese Medicine and immunomodulator .Project for chemotherapy group: Platinum-based chemotherapy were adopted either NVB/TXL/GEM/ TXT+ DDP/CBP regimen was adopted. The end points were median survival time, quality of life , tumor response rate , tumor control rate ,the adverse reaction of the therapy and economic factor. To evaluate the efficacy of the therapy to solid tumor after 2 cycles. The follow-up time was 1 years.Results: 1.The median survival time : the cinobufotalin group was 335 days,the chemotherapy group was 280 days,the cinobufotalin group showed longer median survival time than that of the chemotherapy group. Half-year survival rate was75.65%,56.83% respectively,one-year survival rate was 34.73%,28.24% respectively,there were no statistical significance between the two groups(P>0.05). 2.Tumor response rate(CR+PR) of the cinobufotalin group was 10% ,and 23.3% of the chemotherapy group, no statistical significance was showed between the two groups(P>0.05). The tumor control rate(CR+PR+NC) of the cinobufotalin group was 63.3%,and 73.3% of the chemotherapy group, there were no statistical significance between them. 3.As for quality of life, the improvement rate of which in the cinobufotalin group was 63.3%, was much higher than that of the chemotherapy group with 30% improvement rate of quality of life (P<0.01). 4.Compared with the adverse reaction of the two groups ,including hematologic toxicities, Liver and renal toxicities , and common toxic reaction such as nausea ,vomiting and so on . The incidence rate of hypoleucocytosis in the cinobufotalin group was 3.3%,and the chemo- therapy group was 73.3%. incidence rate of Neutrophilic granulocytopenia in the cinobufotalin group was 3.3%,and the chemotherapy group was 60%.The level of ALT,AST,BUN,Cr in the chemotherapy group was significantly increased , the cinobufotalin group had no obviously change. The incidence of nausea ,vomiting and diarrhea was significantly higher than that in cinobufotalin group .The incidence rate of adverse reaction,the cinobufotalin group was significantly lower than that of the chemotherapy group(P<0.01).Conclusion: Both groups showed similar efficacy in survival time and solid tumor control,but the cinobufotalin group has a certain superiority in quality of life and the adverse reaction .Therefor,in treatment of elderly patients with stage III/IV NSCLC,the cinobufotalin can be recommended as a effective and safety treatment measure which improve quality of life , extend the over all survival,little adverse reaction,low economic cost and a reliable way which achieve the purpose of"Tumor-bearing survival".