| Background & Objective:There was no standard chemotherapy for elderly patients of non-small cell lung cancer. MILES research was the biggest clinic research for elderly patients of non-small cell lung cancer all over the world. The result of this research had shown single-agent efficacy with lower toxicity. However another SEER research showed cisplatin-containing regimens could make elderly patients get clinical benefit.From clinical research some pathological physique types are common in different tumor patients in TCM. The most common physiques of elderly patients with lung cancer are phlegm-stagnate type and qi-yin-deficincy type. We depended on the different physique types of advanced non-small cell lung cancer of elderly patients, and offered different combination of traditional Chinese and western medicine therapy. And we hoped these methods to get good clinical results.Patients & Methods:We conducted an open-label,prospective, multicenter trial.To be eligible, patients had to be aged between 65 years and 80 years; to have cytological ly or histologically confirmed NSCLC; to have stageâ…¢b (with pleural effusion or metastatic supraclavicular lymph nodes)or IV disease. Enrolled between septermber 1st 2009 and March 15th 2011.And fllow-up study closed on March 15th 2012.All patients enrolled this research had received a physique estimate. Patients of qi-yin-deficincy type received single chemotherapy plus herbs of tonifying qi and yin,and patients of phlegm-stagnate type received platinum-based combined chemotherapy plus herbs of dissipating phlegm and removing blood stasis.All treatments were delivered every 3 weeks for a maximum of four cycles.Before the study and after the second cycles of treatments,all patients have to receive radiographic inspection. The patients themselves assessed the functional Assessment of cancer therapy (FACT-L)and doctor assessed clinical syndroms at baseline and 3,6,9 and 12 weeks after the first visit.After treatment follow-up study carried on every 3 months until patients'death or after one year. The primary end point was to compare the cycles of receiving the treatments and response rate. Secondary end points were to compare clinical syndrome,quality of life, progression-free survival and 1 year survival rate with historical documents.Survival cuves were drawn using the Kaplan-Meier method and analyzed by the log-rank test. Results:Of seventy-one patients available for intenion-to-treat analysis, 24 were qi-yin-deficincy type and received single chemotherapy plus herbs of tonifying qi and yin,47 were phlegm-stagnate type and received platinum-based combined chemotherapy plus herbs of dissipating phlegm and removing blood stasis. Patients of qi-yin-deficincy type's median age are 73.15 years,and patients of phlegm-stagnate type's median age are 70 years. There are significant difference between two groups (P<0.05). Patients of this research received average 3.50 treatment cycles. The symptoms were improved over time (P<0.05) in both subgroups. There were significant different in the improvement of physical status, emotional status, functional status and additional concerned status between treatment regimens over time (P<0.05), the scores of social/family status in both groups were similar in all before and after treatment (P>0.05), but no difference between two subgroups. During this research objective response rates (complete or partial) and (CR plus PR plus SD) were 23.94% and 70.42%. Objective response rates (complete or partial) were 12.50% and 29.79% in the qi-yin-deficincy type and phlegm-stagnate type arms, respectively. For this research median PFS was 171 days (95% CI=126 to 187) and MST was 269 days (95%CI=205 to 404),1-year survival rate was 34.12% Median PFS was 184 days (qi-yin-deficincy type) and 171 days (phlegm-stagnate type). 1-year survival rate was 38.10% versus 32.03% for qi-yin-deficincy type versus phlegm-stagnate type respectively.The major side effect was bone marrow suppression grade 1-2.There was no death associate with chemotherapy.Conclusion:Patients of qi-yin-deficincy type received single chemotherapy plus herbs of tonifying qi and yin, and patients of phlegm-stagnate type received platinum-based combined chemotherapy plus herbs of dissipating phlegm and removing blood stasis, these kinds of therapies can improve the cycles of receiving the treatments than historical documents.And it can improve the quality of life of patients to certain extent.Also these kinds of methods have a little superiority in objective response rates,PFS and 1-year survival rate compare purely chemotherapy from historical documents.
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