A Cohort Study Of Aidi Injection Combined With First-line Chemotherapy In The Treatment Of Advanced NSCLC

Background:Lung cancer is the most common and deadly cancer in the world.Due to the characteristics of lung cancer,most patients are already in the advanced stage of losing the opportunity for surgery when they are found.Among them,NSCLC accounts for about 85%of the patients with lung cancer and is the most common pathological type.At present,with the development of tumor precision therapy and second-generation sequencing technology,clinical first-line protocol selection for patients with advanced NSCLC is determined by whether the patients have mutations in the driver genes(EGFR,ALK,ROS1,BRAF,etc.).The first choice for patients with positive driver gene is targeted therapy.Patients with negative driver gene preferred platinum-containing chemotherapy as the first-line regimen.For advanced NSCLC patients who are not eligible for targeted therapy,although the efficacy of double-drug chemotherapy combined with chemotherapy is accurate,the patient's tolerance is significantly affected due to its toxic and side effects such as bone marrow suppression,liver and kidney function damage,fatigue and other systemic symptoms,and there are problems such as progress after drug resistance.With the update of the concept of tumor treatment,the evaluation indexes of tumor treatment are no longer limited to the objective response rate,disease control rate,PFS,OS,etc.,and the subjective feelings and quality of life of patients are increasingly concerned.How to further improve the curative effect of advanced NSCLC chemotherapy,improve the adverse reactions and improve the quality of life of patients is the current clinical hot spot to be solved urgently.Traditional Chinese medicine treatment with its superior compatibility,and safe and reliable efficacy,has been more and more tumor clinical practice has been adopted.A number of clinical studies have confirmed that traditional Chinese medicine combined with chemotherapy can play a synergistic effect on advanced NSCLC,reduce toxic and side effects,and improve the survival status of patients.Aidi injection has been widely used in clinic as a representative of anti-tumor Chinese patent medicine.Objective:To evaluate the efficacy and safety of Aidi injection in first-line chemotherapy of advanced NSCLC.Methods:In this study,a multicenter prospective cohort study was conducted to include 180 patients with stage III-IV NSCLC with a negative driver gene who were initially diagnosed and initially treated in 14 hospitals,and they were divided into Aidi injection combined chemotherapy cohort(hereinafter referred to as "Aidi cohort")and chemotherapy cohort with Aidi injection as exposure factors.Chemotherapy regiments in the chemotherapy cohort were performed according to the standard first-line platinum-containing dual-drug regimen recommended by NCCN guidelines;The Aidi cohort regimen was administered in combination with standard doses(50-100ml Qd)of Aidi injection on the basis of standard first-line chemotherapy regimen.The efficacy and safety of chemotherapy were evaluated after 2 consecutive cycles of 21-28 days.The treatment period of this study was from enrollment to completion of 2 cycles of chemotherapy,and the follow-up period was from 2 cycles of chemotherapy to 1 year after enrollment.The efficacy evaluation criteria for solid tumors(RECIST 1.1)were used to evaluate tumor control.American Lung Cancer Quality of Life Scale(FACT-L4.0)was used to evaluate the quality of life of patients.Karnofsky functional Status score(KPS)was used to evaluate the patients' functional status.The TCM syndromes of patients with lung cancer were evaluated by the TCM clinical syndrome rating scale.Safety was assessed using NCI common Adverse event assessment criteria(CTCAE4.0).The main outcome measure was disease control rate(DCR)after 2 cycles of chemotherapy.Secondary indicators were progression-free survival(PFS),one-year survival,total survival(OS),changes in quality of life score and changes in KPS score.The safety index was the incidence of adverse reactions of different levels.Excel software was used for data entry.Statistical analysis was completed by SPSS26.0 software.Results:In this study,188 NSCLC patients were enrolled from July 2017 to December 2019,including 180 effective cases,including 90 cases in the Aidi cohort and 90 cases in the chemotherapy cohort.There were no statistically significant differences between the two cohorts in gender,age,pathological type,clinical stage,baseline FACT score,baseline KPS and other fields,indicating that the two cohorts were comparable.After 2 cycles of treatment,the DCR of the Aidi cohort was 75.6%,and that of the chemotherapy cohort was 58.9%,with statistically significant differences.The average PFS of the Aidi cohort was 7.05±0.44 months,and the median PFS was 7±0.78 months.The mean PFS of the chemotherapy cohort was 4.56±0.35 months,and the median PFS was 3±0.35 months.The differences were statistically significant The average OS of the Aidi cohort was 11.89±0.07 months,and the one-year survival rate was 79%.The mean OS of the chemotherapy cohort was 11.83±0.08 months,and the one-year survival rate was 69%.The difference was not statistically significant.In terms of quality of life,the median and upper and lower quartiles of the Aidi cohort after 2 cycles of chemotherapy were 89.0(85.0-93.0)and 87.0(82.0-92.0).The difference was not statistically significant However,the quality of life scores of both cohorts were significantly improved compared with baseline.There was no statistically significant difference in KPS scores between the two cohorts after treatment or before and after treatment compared with baseline KPS.There was no statistically significant difference in fatigue status between the two corets after treatment,nor was there statistically significant difference in fatigue status between the two corets before and after treatment compared to baseline.There were statistically significant differences in the improvement of TCM syndrome scores between the two cohorts after treatment,and the Aidi cohorts were significantly superior to the chemotherapy cohorts.In terms of safety evaluation,the number of patients with NCI adverse reactions in the Aidi cohort,including white blood cell(WBC),hemoglobin(HGB)and platelet(PLT),was lower than that in the chemotherapy cohort,and the difference was statistically significant.However,there was no statistically significant difference between the two cohorts in the number of people with adverse reactions in ALT,AST and CRE.Conclusion:Aidi injection combined with first-line chemotherapy in the treatment of advanced NSCLC can improve the disease control rate of patients after 2 cycles and significantly increase the progression-free survival of patients.The 1-year survival rate,total survival time,quality of life score and KPS score all showed a trend of gain,but no statistical significance.It has significant advantages for the improvement of TCM syndromes of patients.It has a significant protective effect on chemotherapy-related adverse reactions of the blood system,but not on the liver and kidney function damage caused by chemotherapy.In general,Aidi injection combined with first-line chemotherapy can reduce toxicity and enhance efficacy in patients with advanced NSCLC,which is worthy of clinical application.