| Background:Lung cancer is the most familiar malignant carcinoma, it ranks first in the incidence and mortality. Every year, there are over 500,000 new cases of lung cancer all over the world, about 80% ~ 85% of them is non-small-cell lung cancer (NSCLC), and about 70% of these cases are advanced NSCLC when diagnose, most of them lose the opportunities for resection, the prognosis of these cases are poor, the median suvival is 6—10 months even accept the most active treatment. NSCLC also may be considered typical of advanced age. More than 60% of NSCLC patients are diagnosed at > 65 years of age and approximately one-third of all patients are > 70 years of age. However, elderly always cannot receive the best treatment in time due to the physical hypofunction, society, family and economic condition. Actually, many studies exclude elderly patients, so find a feasible and effective treatment for elderly NSCLC is the most important for oncologist.Treatment of TCM pay attention to the correlation of whole and local, it' s theory combine supporting "Zheng" and lustrating "Xie ";unify "differentiation of disease" and "differentiation of symptoms" . Treatment of TCM can steady the tumour, prolong the survival and improve the quality of life(QOL). Some clinical studies show that Treatment of TCM has advantage in prolonging the survival compared with chemotherapy in patients of NSCLC. Elderly patients tolerate standard chemotherapy and radiotherapy poorly compared with their younger counterpart because of the progressive reduction of organ function and comorbidities related to age. For this reason, there is much hope for TCM used in elderly NSCLC. However, there is few report about elderly NSCLC treated with TCM, it should be arouse the attention.It is considered in TCM that the cause of the lung cancer due to thedeficiency of the Healthy Energy, so that the body is exposed to the evils, lead inaction and sluggishness of lung-energy, accumulation of phlegm-wetness in the lung. Many symptoms of lung cancer is caused by phlegm. For example, cough and dyspnea is caused by stagnation of phlegm-wetness in lung;emptysis and pain is caused by the retention of phlegm and blood, metastasis of lymphanode is caused by the phlegm-retention in the subcutaneous;metastasis of brain is caused by phlegm which beclouds orifices;accour of tumour in lung is caused by the retention of phlegm and blood. So dealing with the phlegm is the most important in the treatment of NSCLC by TCM, and invigorating the spleen and Benefiting Vital Energy is a primary way in dealing with the phlegm. According to the cognition of lung cancer' s cause and pathogenesis, combine the characteristic of elderly lung cancer, we plan to treat them by "Benefiting Vital Energy and Eliminating Phlegm" of TCM base on "differentiation of disease" and "differentiation of symptoms" . We perform a prospective multicenter randomized trial to search the optimal treatment strategy for elderly patients with advanced NSCLC.Purpose: To evaluate response, survival, quality of life(QOL) and tolerability in patients with advanced-stage (HJ/IV) elderly NSCLC receiving "Benefiting Vital Energy and Eliminating Phlegm" of TCM therapy, and to observe the effect of reducing toxicity and increasing efficacy by combine with chemotherapy. To search the optimal treatment strategy for elderly patients with advanced NSCLC.Patients and Method: The prospective trial is performed in six hospitals at the same time. Between Sept 2003 and Mar 2006, 124 patients with a histologically confirmed diagnosis of stage EH/IV NSCLC were enrolled. Thereinto, 46 patients receive treatment of TCM (group I), 40 patients receive combined treatment of TCM and chemotherapy(group II), 38 patients receive chemotherapy only(group HJ). Project for group I : 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: phlegmatic stagnation due to passive congestion of lungs(FYTY), phlegmatic hygrosis dueto spleen asthenia(PXTS), yin-deficiency and phlegmopyrexia(YXTR) and deficiency of both qi and yin(QYLX) according to syndrome diffentiation, and the period of treatment was three courses, 1 month per course. Project for group II: thetreatment of TCM is the same as group TCM, chemotherapy is the same as group western medicine. Project for group Ed: Platinum-based chemotherapy were used, either NP/GP/TP/DP regimen was adopted, and were repeated every 21days, 3 times. The primary end point wais survival and QOL, the other end points included time to disease progression(TTP), tumor response rate, symptoms improvement, weight change etc..Result: The median survival time of three group were group I 310 days, group II 292 days and group HI 177 days, with a 1-year survival rate of 39. 71%> 32.33% and 22.87%(P=0. 0052), respectively. TTP of three group were groupI 183 days, group II182 days, group HI 122 days respectively, there were no statistical significance between three groups.The COX regression analysis involve 12 covariates: treatment, sex, course of diseases, location of tumour, stage, statas of metastasis, TCM syndrome differentiation, treatment used have received, Carcinoembryonic antigen(CEA), performance status(PS), weight, symptoms before treatment.The result showed that independent prognosis factors included performance status (PS), treatment, course of diseases and location of tumour.The result of QOL show that TCM and treatment integrating TCM and Western medicine can improve the QOL of advanced elderly NSCLC in physical> emotionaK functional and additional concerning domain.Tumor response rate(CR+PR) were 4.3% of group I, 22.5% of group II, 13. 2% of group m(P=0. 043);The disease control rate were 76. l%of group I, 77. 5%of group II, 63. 2%of group HI;there were no statistical significance between three groups.Performance status improvement compared shows that both group I and groupII are better than group III, there were statistic significance between three groups. Body weight changes compared, patients of weight loss ^ 5 % increased with disease history grow, the change of the body weight is slight through out the process in group I and group II, but the weight lose significant along with the process, group I and group II can also improve the clinical symptoms related to the carcinoma, especially for fatigue^ appetites thirstiness. This suggested that TCM treatment could keep body weight well.No severe adverse events had been observed in the trial. Much fewer hematologic toxicities were reported in group I than group II and group HI.Conclusions: The treatment of TCM can extends the over all survival, improve the QOL of elderly patients with advanced NSCLC in a poor condition, and it seems can reduce the toxicities of chemotherapy.The treatment of TCM seems preponderant on improving the clinical symptoms and steadying tumours and weight.The treatment of TCM can be recommended as a feasible treatment strategy for elderly patients with advanced NSCLC, and "Benefiting Vital Energy and Eliminating Phlegm" can be considered as a primary therapeutic principle of TCM.
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