| BackgroundLung cancer is the most common malignancy in China.The incidence rate of Non-Small Lung Cancer(NSCLC)is 80%to 85%of the total lung cancer.Since the early symptoms and signs of NSCLC are not obvious,more than 70%of the patients are in advanced stage at the time of diagnosis,and have lost the opportunity of surgical treatment.Without driving gene expression,platinum containing dual drug chemotherapy has become one of the main means of treatment for advanced NSCLC.Previous studies have shown that the curative effect of advanced NSCLC reaches the plateau stage after 4-6 cycles of first-line platinum containing double drug chemotherapy.Most patients with stable lesions enter the "waiting period" for regular review,or choose to reduce or single drug chemotherapy for maintenance treatment,until the disease progresses and adopt second-line chemotherapy.Compared with the "waiting period" without intervention,the maintenance treatment of reduced dose or single drug chemotherapy can prolong the prognosis of PFS and OS,but it also causes adverse reactions such as the accumulation of toxicity of chemotherapy drugs,the decline of bone marrow function and physical status of patients,which affect the subsequent treatment.A number of previous studies have shown that traditional Chinese medicine treatment can effectively control the development of tumor,improve clinical symptoms,improve the quality of life of patients,synergize with chemotherapy drugs to detoxify,and prolong the survival time of patients.In view of this,we believe that traditional Chinese medicine will play a better role in the maintenance treatment,and the improvement of PFS and OS may not be inferior to the maintenance of chemotherapy drugs.The curative effect of collaborative Chinese and Western medicine cohort may be better than the maintenance of chemotherapy drugs alone,and it has obvious advantages in improving the quality of life of patients.The Department of oncology of integrated traditional Chinese and Western medicine of Sino Japanese hospital and the Department of oncology of Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine have jointly presided over or participated in the retrospective study of the national "sixth five year plan to the Tenth Five Year Plan".On the basis of a large number of literature review and expert consultation,a comprehensive treatment plan of advanced NSCLC based on syndrome differentiation and treatment was formed.The purpose of this study is to verify and evaluate the efficacy of traditional Chinese medicine comprehensive treatment for NSCLC in the maintenance treatment stage by prospective cohort study,and try to explore the risk factors of prognosis and the potential advantages of Integrated Chinese and Western maintenance treatment and traditional Chinese medicine maintenance treatment.ObjectiveObjective To observe the effectiveness of traditional Chinese medicine(TCM)comprehensive treatment for PFS and OS in the maintenance treatment stage of advanced NSCLC,analyze the risk factors that may affect the prognosis of each cohort,and explore the potential advantage population of Integrated Chinese and Western maintenance treatment and TCM maintenance treatment.MethodIn this prospective cohort study,42 patients with stage III-IV NSCLC who received 2-6 courses of first-line chemotherapy in China Japan Friendship Hospital from March 1,2017 to June 31,2020 were included.Among them,24 patients were treated with integrated Chinese and Western medicine,and 18 patients were treated with traditional Chinese medicine.Traditional Chinese medicine comprehensive treatment queue to Yiqi Huoxue,Jiedu Sanjie as the general guiding principle,disease differentiation combined with syndrome differentiation,choose advanced non-small cell lung cancer TCM Comprehensive treatment scheme recommended the corresponding treatment principle of traditional Chinese medicine injection,Chinese patent medicine,traditional Chinese medicine decoction(or formula particles)treatment(see traditional Chinese medicine comprehensive treatment scheme).The treatment group was treated with NCCN guideline standard maintenance chemistry+traditional Chinese medicine injection/syndrome differentiation DECOCTION/syndrome differentiation proprietary Chinese medicine.This project belongs to the project of Beijing Municipal Science and Technology Commission.Another Western medicine observation cohort is set up in the general project.The standard scheme of NCCN guidelines is used for maintenance treatment,and the results can be used for comparison and reference.The clinical data of patients were collected and evaluated every two cycles from 21 to 28 days.The patients were followed up until the end event occurred.By analyzing the correlation between clinical data,PFS and OS of different cohort patients,the effectiveness of the two groups was verified and compared,and the prognostic risk factors and dominant population were analyzed.We used graphpad prism 8 and spss23.0 software for statistical mapping,Kaplan Meier method to predict the survival time and prognostic risk factors,Cox multivariate regression model to compare the independence and effect of each prognostic factor,ROC curve to analyze the sensitivity and specificity,and log rank method to test the survival difference.Results1.There was no significant difference in age(P=0.867),gender(P=0.074),pathological type(P=0.789),metastasis site(P=0.365),TNM stage(P=0.103),ECoG score(P=0.099),KPS score(P=0.074)between the two groups,and the baseline data were comparable;2.The average number of TCM treatment cycles in the maintenance cohort of TCM comprehensive scheme was 12±7 cycles(252±7 days);The average number of maintenance chemotherapy cycles was 3.8±7 cycles(79.8 2±7 days),the average treatment time of traditional Chinese medicine was 8±4 cycles(184.8 8±4 days).The comparison of TCM maintenance treatment between groups showed that the maintenance time and cycle number of TCM group were higher than that of Integrated Chinese and Western medicine group.The comparison of TCM and Western medicine in integrated Chinese and Western medicine group showed that the maintenance time and cycle number of Western medicine were significantly less than that of traditional Chinese medicine maintenance treatment.3.Survival analysis showed that the MPFs of the integrated Chinese and Western cohort was 149 days(P25:83 days;P25:83 days);P75:270 days),MOS:455 days(P25:274 days;P25:270 days);P75:903 days);The MPFs of TCM cohort was 140 days(P25:71 days;P25:71 days);P75:356 days),MOS:604 days(P25:268 days;P25:356 days);There was no significant difference between the two groups by log rank test(P>0.05);4.The analysis of prognostic factors showed that the presence of bone metastasis(P=0.018),pathological stage ?(P=0.015),abnormal D-D(P=0.005),FIB(P=0.049),FDP(P=0.013)and tumor markers CEA(P=0.009),CA125(P=0.000),CA-199(P=0.003),CYFRA21-1(P=0.002)were prognostic factors in patients with advanced NSCLC;5.In multivariate Cox regression analysis,the total regression model p value of coagulation index was 0.007,which indicated that hypercoagulable state had a significant impact on the prognosis of patients,but each coagulation index was not an independent prognostic risk factor(P>0.05).FIB was the best in sensitivity and specificity,followed by D-D,better than FDP;Multivariate Cox regression analysis of tumor markers showed that CA125(P=0.000)and CA-199(P=0.030)were independent risk factors for the prognosis of NSCLC patients,and CA125 was more important than CA-199.6.Subjects in the full analysis set were divided into oral Chinese medicine decoction group and non oral Chinese medicine decoction group according to whether they took oral Chinese medicine decoction or not.There was no significant difference in the overall survival between the two groups(P=0.429),but the short-term survival benefit of non oral Chinese Medicine decoction group was better(within 430 days),and the long-term survival benefit of oral Chinese medicine decoction group was better(after 430 days);7.The study of preponderant population showed that under the risk factors of stage IV,bone metastasis,tumor marker elevation and abnormal coagulation index,the efficacy of comprehensive treatment of traditional Chinese medicine was not inferior to that of integrated traditional Chinese and Western Medicine(P>0.05).In addition,in the normal population of CEA,the survival of comprehensive treatment of traditional Chinese medicine was more beneficial than that of integrated traditional Chinese and Western medicine.ConclusionThe long-term survival benefit of patients with stage ?-? NSCLC treated with TCM Comprehensive Scheme maintenance treatment cohort was not inferior to that of patients treated with integrated Chinese and Western schemes maintenance treatment cohort,and the patients treated with TCM Comprehensive Scheme in maintenance treatment phase showed better treatment tolerance,which could prolong the interval of maintenance chemotherapy and reduce the number of chemotherapy;Prognosis analysis showed that bone metastasis,pathological stage ?,hypercoagulable state in blood and elevated tumor markers CA125 and CA-199 were risk factors for prognosis of patients with advanced NSCLC.There was no significant difference in the effect of dialectical Chinese medicine decoction on the prognosis of patients in the maintenance treatment stage of TCM comprehensive scheme,but patients who used Chinese medicine decoction in the later stage of disease had better survival benefit.Under the influence of different risk factors,the curative effect of TCM Comprehensive treatment is not inferior to that of integrated traditional Chinese and Western medicine,and TCM Comprehensive treatment may have a better benefit trend in normal CEA population. |
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