Professor Hua Baojin's Clinical Observation On The Treatment Of Chemotherapy-sensitive Small Cell Lung Cancer With Integrated Chinese And Western Medicine

Objectives:We observed the effect of series of prescription treatment used by professor Hua Baojin to Overall survival(OS),Progression-free survival time(PFS).This study tried to analyze the appropriate timing of intervention in the whole treatment process among the chemotherapy-sensitive small cell lung cancer patients and discuss the characteristic of the prescription.We hope we can get positive results to provide the basis and help for the small cell lung cancer patients.Methods:This study was conducted by a exploratory cohort study including outpatients who were admitted to Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Cancer Hospital Chinese Academy of Medical Sciences from October 2013 to December 2015.According to whether or not to accept Traditional Chinese Medicine(TCM)as exposure factors,the whole patients were divided into Chinese combined Western medicine cohort and Western medicine cohort.A total number of 65 patients were enrolled in the study,with 5 shedding cases.Chinese combined Western medicine cohort were 34 cases,including 25 cases of limited disease and 9 cases of extensive disease,Western medicine cohort were 31 cases,including 20 cases of limited disease and 11 cases of extensive disease.Western medicine cohort were treated with EP/CE first-line chemotherapy treatment for at least 4-6 cycles,combined radiotherapy with the actual situation.The western medicine treatment of Chinese combined Western medicine group was the same with Western medicine group.Chinese medicine treatment based on different elements of differentiation and Western medicine treatment stage to be a series of prescription.Qi Deficiency:mainly includes Astragalus memeranaceus Bge.,Atractylodes macrocephala Koidz.,Poria cocos Wolf.,and Citrus reticulata Blanco.;Yin Deficiency:mainly includes Glehnia littoralis Fr.Schmidt ex Miq.and Ophiopogonis japonicus Ker-Gawl.;Phlegm-damp:mainly includes Trichosanthes kirilowii Maxim.and Allium macrostemon Bge.;Blood Stasis:mainly includes Prunus persica Batsch.,Paeonia lactiflora Pall.,Zhicqieao,Platycodon grandiflorum A.DC.,Bupleurum chinensie DC.,Ligusticum chuanxiong Hort.;Heat Poison:mainly includes Ephedra sinica Stapf.,Prunus armeniaca L.Var.Ansu Maxim,and Shigao.Chemotherapy stage:mainly includes Inula japonica Thunb.,Daizheshi,Pinellia ternata Breit.,Coptis chinensis Franch.,Rehmannia glutinosa Libosch.,Cornus officinalis Sieb.Et Zucc.,Equus asinus L.,and Lujiaoshuang.Radiotherapy stage:mainly includes Glehnia littoralis Fr.Schmidt ex Miq.,Ophiopogonis japonicus Ker-Gawl.,Trichosanthes kirilowii Maxim.,Allium macrostemon Bge.,Platycodon grandiflorum A.DC.,Hegeng,Zisugeng,Ephedra sinica Stapf.,Prunus armeniaca L.Var.Ansu Maxim.and Shigao;maintenance treatment:mainly includes Astragalus memeranaceus Bge.,Atractylodes macrocephala Koidz.,Poria cocos Wolf.,and Citrus reticulata Blanco.,Gastrodia elata Bl.,Uncaria rhynchophylla Jacks.,Haliotis diversicolor Reeve.,Rheum palmatum L.,Curcuma longfa L.,Bombyx mori Linnaeus.and Cryptotympana pustulata Fabricius..After 4-6 cycles of chemotherapy,the study got into the follow-up phase.The primary observational outcome included overall survival time(OS),progression-free survival,1-year survival,2-year survival,no progression rate in six months,1 year disease progression rate,2 year disease progression rate.Secondary indicators included evaluation of the efficacy of solid tumors,improvement of TCM symptom score,changes of KPS score,and NCI adverse reactions.In addition,this study also observed the effect to the progression-free survival by the timing of the intervention of Traditional Chinese Medicine and discussed the characteristic of the prescription.Results:1 Survival analysis:(1)The median survival time of Chinese combined Western medicine group and the Western medicine group was 24 and 20 months respectively,the difference was not statistically significant(P=0.221),1 year,2 years cumulative survival rate was 94.1%,64.7%and 80.6%,51.6%.The median survival time of Chinese combined Western medicine group and the Western medicine group in limited disease was 25 and 22 months respectively,the difference was not statistically significant(P=0.656),1 year,2 years cumulative survival rate was 88.9%,22.2%and 72.7%,18.2%.The median survival time of Chinese combined Western medicine group and the Western medicine group in extensive disease was 22 and 16 months respectively,the difference was not statistically significant(P=0.218),1 year,2 years cumulative survival rate was 96.0%,48.0%and 85.0%,35.0%.(2)The median progression-free survival time of Chinese combined Western medicine group and the Western medicine group was 19 and 14 months respectively,the difference was not statistically significant(P=0.098),half year,1 year,2 years no progress rate was 91.2%,70.6%,44.1%and 74.2%,51.6%,29.0%.The median progression-free survival time of Chinese combined Western medicine group and the Western medicine group in limited disease was 19 and 15 months respectively,the difference was not statistically significant(P=0.421),half year,1 year,2 years no progress rate was 96.0%,80.0%,48.0%and 85.0%,60.0%,35.0%.The median progression-free survival time of Chinese combined Western medicine group and the Western medicine group in extensive disease was 11 and 7 months respectively,the difference was not statistically significant(P=0.289),half year,1 year,2 years no progress rate was 77.8%,44.4%,33.3%and 54.5%,36.4%,18.2%.(3)In accordance with the different intervention time,the Chinese combined Western medicine group were divided into intervention within 6 months group and intervention after 6 months group.The median progression-free survival was 24 and 19 months,respectively,and the difference was not statistically significant(P=0.809).But the median progression-free survival of the intervention within 6 months group was extended for 5 months.(4)Separated by 60 years old,the median survival time of no more than 60 year-old and more than 60 year-old group was 25 and 21 months,respectively,and the difference was statistically significant(P=0.002).(5)The median survival time of men and women was 22 and 24 months,respectively,and the difference was not statistically significant(P=0.904).(6)Separated by KPS score,the median survival time of KPS 70 points,80 points and 90 points group were 12,22 and 25 months.The difference between KPS70 and 80 points group was statistically significant(P = 0.000).The difference between KPS70 and 90 points group was statistically significant(P = 0.001).The difference between KPS80 and 90 points group was not statistically significant(P = 0.904)(7)The median survival time of chemotherapy alone,sequential,sandwich and concurrent chemoradiotherapy was 20,22,24 and 32 months respectively.The difference between single drug chemotherapy and other groups was statistically significant(P<0.05).(8)According to the performance of PCI,the median survival time of PCI and non-PCI was 32 and 20 months,respectively,the difference was statistically significant(P=0.006).2 Prognosis:The prognostic factors of the Cox proportional hazards model were Cohort,Age,KPS score and PCI condition.Wald values were 3.643,7.004,4.578 and 8.811,the regression coefficients were-0.595,0.859,-1.320 and-1.008.The relative risk was 0.551,2361,0.267 and 0.355 respectively.The P values were 0.056,0.008,0.032 and 0.003 respectively.3 Evaluation of solid tumor effect:The total effective rate of the two groups(42days and 84 days of treatment)was not statistically significant(P>0.05).After 126 days of treatment,the difference of total effective rate between the two groups was tend to be statistically significant with the worth of P equal to 0.052.After 42 days of treatment,there was no significant difference in tumor control rate between the two groups(P>0.05).The rate of tumor control was statistically different at 84 days and 126 days after treatment(P =0.015 and 0.031,respectively).4 KPS score changes:42 days,84 days,126 days KPS score changes,compared two cohort,the difference was statistically significant(P<0.05).5 Comparison of clinical symptoms of Traditional Chinese Medicine:To compare the efficacy of clinical symptoms of Traditional Chinese Medicine before and after treatment,the difference between Chinese combined Western medicine group and Western medicine group was statistically significant(P<0.05).We analyzed the symptom scale,the results found that the gap between Chinese combined Western medicine and Western medicine cohort was statistically significant in improving the following seven symptoms:fatigue,shortness of breath,poor appetite,spontaneous sweating,dry mouth and throat,chest tightness,cough and constipation(P<0.05).6 NCI adverse reaction analysis:In the blood system adverse reactions,leukocyte and thrombocytopenia adverse reactions,the difference between the two cohorts was not statistically significant(P>0.05),in neutrophils and hemoglobin to reduce adverse reactions,the difference between the two cohorts was statistically significant(P<0.05).In the adverse reactions of the digestive system,there was no statistically significant difference between the two groups(P>0.05).In the adverse reactions of the urinary system,the adverse reactions of creatinine were different,and the difference was statistically significant(P<0.05).7 Study prescription analysis:According to the different elements of differentiation and Western medicine treatment stage,the prescriptions used ups and downs,flavor and meridian tropism of the drug so that the viscera could recover to their respective physiological characteristics,back to the balance,thereby improving the persistent vicious environment the body.Conclusions:1 Newly diagnosed as small cell lung cancer with age no more than 60 year-old,KPS score more than 70 points,the implementation of PCI are beneficial factors for small cell lung cancer prognosis.2 The series of prescription treatment guided by the "Ascending and descending of qi activity" combined Western medicine treatment which professor Hua Baojin used could improve chemotherapy-sensitive small cell lung cancer patients' physical condition,relieve clinical symptoms and reduce the blood and urinary system adverse reactions compared with Western medicine treatment alone.It also has a role in the extension of OS,PFS,which suggested that early intervention may be better,but it still needs to expand the sample size to get verified.