Objective: To evaluate survival and symptoms for the patients with advanced-stage elderly NSCLC. The aim is that extends the over all survival and to improve complaint. Observation the effect and reducing toxicity and increasing efficacy by combine with chemotherapy of The device of Nourishing Qi and Eliminating Phlegm To search the optimal treatment strategy for elderly patients with advanced NSCLC.Methods: The prospective trial is performed in tumor organization of GuangZhou TCM university. Between March 2005 and April 2007,66 patients with a histologically confirmed diagnosis of stageâ…¢/â…£NSCLC were enrolled. Thereinto, 33 patients receive treatment of TCM (groupâ… ), 17 patients receive combined treatment of TCM and chemotherapy (groupâ…¡), 16 patients receive chemotherapy only (groupâ…¢). Project for groupâ… : with combination of syndrome differentiation and disease differentiation, Hechan tablets and Shenyi capsules were used according to disease differentiation, and different decoctions were determined from four patterns: Feiyutanyu, Pixutanyu, Yinxutanreand Qiyinliangxu according to syndromediffentiation, and the period of treatment was three courses, 1 month per course. Project for groupâ…¡: the treatment of TCM is the same as groupâ… , chemotherapy is the same as groupâ…¢. Project for groupâ…¢: Platinum-based chemotherapy were used, either NVB/TXL/GEM/TXT+DDP/CBP regimen was adopted. The primary end point is survival, symptom and the adverse reaction of chemotherapy, the other end points included tumor response rate, CEA, ESR, weight change and so on.Results: The median survival time of three group were groupâ… 326 days, groupâ…¡307 days and groupâ…¢220 days, with a l-year survival rate of 36.67% , 46.67% and 26.67% (P>0.05), there were no statistical significance between three groups.Tumor response rate (CR+PR) were 10.0% of groupâ… , 40.0% of groupâ…¡, 46.61% of groupâ…¢(P<0.05), there were statistical significance between three groups. The tumor control rate (CR+PR+SD) were 66.67% of groupâ… , 46.67% of groupâ…¡, 53.33% of groupâ…¢, there were no statistical significance between three groups.Body weight changes compared, the change of the body weight is slight through out the process in groupâ… and groupâ…¡, the change of the body weight is significant in groupâ…¢at the 63 days and 84 days, but there were no statistical significance.Groupâ… and Groupâ…¡can improve the clinical symptoms, especially for fatigue, appetite, emetische, thirstiness.No severe adverse events had been observed in the trial. But, hematologic, Liver function and renal function toxicities were reported in groupâ… than groupâ…¡and groupâ…¢.Conclusions: The treatment of TCM can extends the over all survival, to improve complaint of the patients with advanced NSCLC in a poor condition, and it seem can reduce the adverse reaction of chemotherapy.The treatment of combination of TCM with Western medicine seems preponderant on improving the clinical symptoms and steadying tumors.The device of Nourishing Qi and Eliminating Phlegm can extends the over all survival, to improve complaint and quality of life for elderly patients with advanced NSCLC, and the treatment of TCM can be recommended as a feasible treatment strategy for elderly patients with advanced NSCLC.
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