Based On Literature And Real World Studies,the Study On The Clinical Efficacy Of The Traditional Chinese Medicine For Yiqi Qutan Prescription Combined With PD1/PD-L1 Monoclonal Antibody In The Treatment Of Advanced Lung Cancer

BackgroundPatients with advanced lung cancer have lost the opportunity of surgical treatment when they are diagnosed.Therefore,the clinical situation they face is still not optimistic.Since the launch of tumor immunotherapy in China in2018,the comprehensive treatment of advanced lung cancer has stepped into a new therapeutic field.PD1/PD-L1 monotherapy is one of the most studied immune checkpoint inhibitors at present.In addition,Professor Lizhu Lin’s team has been committed to the research of treating lung cancer with Chinese medicine for nearly 30 years.And successfully developed a treatment program of the method of Yiqi Qutan(Invigorating Qi and eliminating phlegm).At the same time,a lot of research has been done on the anti-cancer mechanism of this program.The results showed that it had a positive effect on the long-term maintenance treatment of patients.There is no sufficient evidence to show whether PD1 monotherapy in combination with the method of Yiqi Qutan provides a higher benefit.It is also unknown whether the addition of traditional Chinese medicine to Yiqi Qutan can improve the related adverse reactions caused by PD1 monotherapy treatment,or enhance the efficacy of drugs,or prolong the survival period of patients.ObjectiveThe survival outcome of PD1/PD-L1 monoclonal antibody in the treatment of advanced lung cancer in previous clinical studies was analyzed through literature review.Through real-world clinical studies,to evaluate the clinical efficacy and quality of life of the traditional Chinese medicine for Yiqi Qutan combined with PD1/PD-L1 monoclonal antibody in the treatment of advanced lung cancer in the Cancer Center of the First Affiliated Hospital of Guangzhou University of Chinese Medicine to explore the prognosis of immunotherapy research in the real world.Methods(1)The literature review analyzed the research status of PD1/PD-L1 monoclonal antibody in the treatment of advanced lung cancer.Search in Pub Med,EMBASE,The Cochrane Library,CNKI,VIP database and Wan Fang database.The search time is up to July 2020.Collect the SR/Meta analysis of PD-1/PD-L1 immunotherapy versus chemotherapy and other standard treatment regimens for advanced lung cancer.Descriptive statistical analysis methods were used to aggregate and evaluate progression-free survival,overall survival,and adverse reactions.(2)Real-world study analysis of quality of life evaluation of the traditional Chinese medicine for Yiqi Qutan combined with PD1/PD-L1 monoclonal antibody in the treatment of advanced lung cancer.Collect data from patients with advanced lung cancer who were hospitalized in the Cancer Center of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine from April 2018 to November 2020.And the treatment method was the use of Chinese medicine for Yiqi Qutan combined with PD1/PDL1 monoclonal antibody for more than 2 courses of treatment.Follow-up survival outcomes,including: progression-free survival(PFS),time required to achieve optimal efficacy,and duration of immunotherapy.And through the single factor Log-rank test analysis,calculate the correlation between each baseline index and survival outcome.Cox regression model was used for multivariate analysis.Using Empower Stats analysis method,p<0.05 was regarded as meaningful.Results(1)A total of 24 SR/Meta analyses included in the literature search,Compared with other western medicine treatments such as chemotherapy,PD1/PD-L1 monoclonal antibody can improve the progression-free survival(PFS)and survival time(OS)of patients with advanced lung cancer.In addition,it reduces the adverse reactions of patients to a certain extent,such as hypothyroidism,hyperthyroidism,rash,pneumonia,etc.,but the overall improvement effect is not obvious.(2)A total of 84 patients were enrolled in the real-world clinical study.There were 9 patients with stage IIIA,6 patients with stage IIIB(7.1%),9patients with stage IIIC,33 patients with stage IVA,and 27 patients with stage IVB.For baseline data,smoking is related to gender(P =0.002),smoking is related to staging(P =0.033),and cardiovascular history is related to ECOG score(P =0.044).Among 84 cases,55 cases showed progression,29 cases were truncated data,and the median progression-free survival time of patients was 8.7 months;The optimal efficacy was achieved in 36 patients,48 cases were truncated data,and the median optimal therapeutic time was 9.4 months.There were 63 patients who had stopped using immunotherapy,and 21 patients had truncated data.The median duration of immunotherapy was 9.2 months.Age and ECOG score affect the patient’s progression-free survival(PFS)and treatment duration(age: P =0.004 and P =0.001)(ECOG score: P =0.01 and P=0.006).Plasma fibrinogen has an effect on the patient’s PFS(P=0.046).Neutrophils/lymphocytes(NLR)have a certain impact on survival outcome(PFS),the time required to achieve optimal efficacy,and the duration of treatment(P =0.003 for all).Albumin,prealbumin and lactate dehydrogenase(LDH)may be prognostic factors for survival outcomes.Further COX regression results show that ECOG score is a prognostic factor affecting PFS.Neutrophils/lymphocytes(NLR)affect PFS in survival outcome and duration of medication(P=0.013 and P=0.002);Lactate dehydrogenase(LDH)has a certain impact on the three survival outcomes,and it is also an independent prognostic factor that affects the optimal treatment time.ConclusionThe results of this study show that no matter Immunosuppressant monotherapy or combined with other Western medicine treatments,regardless of the number of immunotherapy lines,and the expression of PD-L1 protein,the traditional Chinese medicine for replenishing qi and eliminating phlegm combined with PD1/PDL1 monoclonal antibody in the treatment of advanced lung cancer can achieve clinical efficacy beyond ideal,and improve patient survival outcomes.Age and ECOG score are the objective factors affecting the outcome of curative effect.Clinically,more attention should be paid to elderly patients and patients with poor physical condition assessment results.Neutrophils/lymphocytes(NLR),albumin,prealbumin,and lactate dehydrogenase are the measurement factors affecting the prognosis of patients.Clinically,a preliminary assessment of measurable data can be used to understand a patient’s potential treatment dynamics.It is helpful for clinicians to draw up more reasonable medication plans.