Prospective Cohort Study On Patients With Advanced Non-small-cell Lung Cancer Treated By Conbined Treatment Of Traditional Chinese Medicine And Western Medicine

The morbility and mortality of lung is among the top of all malignant cancers. It is estimated that, in 2025, the number of lung cancer cases will be more in China than in any other countries in the world. Non-small cell lung cancer(NSCLC) accounts for approximately 80% of all cases of lung cancer, with 65% to 75% of them having locally advanced or metastatic disease. TCM plays an important role in the treatment of lung cancer in China. Actually,TCM emphasize on determination of treatment based in pathogenesis obtained through differentiation of symptoms and signs in the treatment of tumor. Medicinal broth, Chinese patent medicine and parenteral solution can be used for treatment of tumor according to syndrome and stage of disease. But, most previous clinical studies observed and assessed effect of single drug or treatment tool because of limitation of scientific research method-- randomized controlled trial.In those clinical studies,Characteristic of determination of treatment based in pathogenesis obtained through differentiation of symptoms and signs,was not displayed.This study is perspective cohort clinical trial, to assess effect and security of therapeutic regimen of TCM in 223 NSCLC patients with stageⅢ-Ⅳ,which include medicinal broth, Chinese patent medicine and parenteral solution,and try to provide reliable clinical data for formulating better therapeutic regimen of advanced NSCLC. Purpose First,to observe and assess the effect and security of therapeutic regimen of TCM combined with western medicine, and to provide reliable clinical data for formulating better therapeutic regimen of advanced NSCLC.Second,to approach Characteristic of distribution and developing of syndrome in advanced NSCLC.Method This study is a perspective cohort clinical trial, and recruited 223 NSCLC patients with stageⅢ-Ⅳwho are unresectable.Patients were allocated into two arms. The arm A exercised strategy of combined western and Chinese medicine treatment, including 115 patients with advanced NSCLC, arm B exercised strategy of western medicine treatment alone, including 108 patients with advanced NSCLC. Western medicine will base on NCCN clinical practice guidelines in oncology in 2006. Chinese medicine treatment principle will change according to different treatment period.During chemotherapy the principle of invigorating the spleen and stomach, invigorating qi and enriching the blood, and tonifying and nourishing liver and kidney will be applied. During radiotherapy time,the principle of nourishing yin and promoting production of body fluid, promoting blood circulation by removing blood stasis, and detoxicating will be taken.For the patients during interval of chemotherapy or radiotherapy,qi-reinforcing and activating blood,eliminating stagnation,and detoxicating will be applied.Primary observation indexes include median survival time,time to progress(TTP),1-year survival rate,2-year survival rate,and tumor size, performance status(PS), clinical symptoms,therapeutic-related adversities,and so on,refer to the secondary indexes.Besides,TCM syndrome was observed and analyzed before, and 42 days,84 days,5,9,13,17 months after treatment respectively.Results The midian survival time of arm A and arm B was 506 days and 410 days respectively(P=0.015).1-year survival rate was 68.8% and 52.9% respectively,2-year survival rate was 26.7% and 13.9% respectively.In the case of PS score=1, the midian survival time of arm A and arm B was 614 days and 494 days respectively(P=0.032). In the case of PS score>1, the midian survival time of arm A and arm B was 218 days and 212 days respectively(P=0.427).The COX regression analysis showed that treatment groups,PS score before treatment and accumulated points of clinical symptoms before treatment were independent prognosis factors. Besides,patients who were assessed as PD have a shorter median survival time than patients who were assessed as non-PD.Analysis of performance status improvement showed that arm A had a better effect compared with arm B 42 days,84 days,5,9,13 months after treatment(P<0.05).Analysis of clinical symptoms improvement showed that arm A had a better effect compared with arm B 42 days,84 days,5,9,13 months after treatment(P<0.05).Arm A had an advantages in improving symptoms such as short breath, chest distress, dry mouth, lassitude, poor appetite, spontaneous perspiration and night sweat(P<0.05). Analysis of therapeutic-related adversities showed that arm A had an advantages in reducing and lessening digestive tract reaction compared with arm B (P<0.05).There are 20 types of syndrome in 115 cases,which can mainly sum as 4 patterns: deficiency of both vital energy and yin, deficiency of both vital energy and yin combine other syndrome elements(including phlegm,blood stasis and bane),deficiency of vital energy, deficiency of vital energy combine other syndrome elements.All the 4 patterns account for 64.3%,80.7%,86.8%,75.0%,89.7%,90.7%, 94.6% before, and 42 days,84 days,5,9,13,17 months after treatment respectively. Asthenia syndrome account for 41.7%,44.7%,46.2%,37.5%,46.2%,33.3%,27.0% before, and 42 days,84 days,5,9,13,17 months after treatment respectively (P>0.05). Sthenia syndrome account for 26.1%,7.9%,8.5%,18.8%,16.7%,3.7%,2.7% before, and 42 days,84 days,5,9,13,17 months after treatment respectively.Syndrome of intermingled deficiency and excess account for 32.2%,47.4%,45.3%,43.8%, 50.0%,63.0%,70.3% before, and 42 days,84 days,5,9,13,17 months after treatment respectively.Syndrome element of deficiency of QI account for 64.3%,80.7%,86.8%,75.0%, 76.9%,90.7%,94.6% before, and 42 days,84 days,5,9,13,17 months after treatment respectively. Syndrome element of yin asthenia account for 40.9%,48.2%,50%, 34.4%,42.3%,51.9%,62.2% before, and 42 days,84 days,5,9,13,17 months after treatment respectively. Syndrome element of phlegmatic hygrosis account for 40.0%, 40.4%,43.4%,37.5%,46.2%,50.0%,64.9% before, and 42 days,84 days,5,9,13,17 months after treatment respectively. Syndrome element of stagnation of blood account for 38.3%,43.9%,39.6%,43.8%,48.7%,51.9%,62.2% before, and 42 days,84 days,5,9,13,17 months after treatment respectively.Conclusion 1) Compared with western medicine,conbined treatment of traditional Chinese medicine and western medicine can prolong median survival time, boost 1-year survival rate,2-year survival rate,and patients who have better PS can benefit from conbined treatment of traditional Chinese medicine and western medicine.2) The COX regression analysis showed that treatment groups,PS score before treatment and accumulated points of clinical symptoms before treatment were independent prognosis factors.3) It is worth to spread the therapeutic regimen of TCM based on determination of treatment based in pathogenesis obtained through differentiation of symptoms and signs.4) TCM syndrome distribution of the advanced NSCLC is characterized as complexity and diversity. Deficiency of vital energy and deficiency of both vital energy and yin are most common syndromes in advanced NSCLC, especially deficiency of both vital energy and yin.With lapse of course of advanced NSCLC, asthenia syndrome and sthenia syndrome are less and less,but syndrome of intermingled deficiency and excess is more and more. With lapse of course, syndrome element of deficiency of QI,yin asthenia,phlegmatic hygrosis and stagnation of blood are more and more.After chemotherapy or radiotherapy, asthenia syndrome had no conspicuous change, sthenia syndrome decreased,and syndrome of intermingled deficiency and excess increased. After chemotherapy or radiotherapy, syndrome element of deficiency of QI increased,other syndrome elements had no conspicuous change.