| ObjectiveIn this study,we observed the pro gression-free survival,objective remission rate,and the occurrence of major adverse reactions in patients with advanced NSCLC treated with traditional Chinese medicine combined with chemotherapy and PD-1 antibody,compared with historical trial data of stduy in which patients treated with chemotherapy combined with PD-1 antibody to explore the effectiveness and safety of this treatment,to observe whether Chinese medicine prolongs the progression-free survival time of patients with advanced NSCLC treated with chemotherapy combined with PD-1 antibody,and at the same time reduces toxic and side effects in immunotherapy.MethodsAccording to the inclusion and exclusion criteria of the clinical study protocol,all NSCLC patients admitted to the Oncology Department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine and receiving first-line treatment from October1,2018 to February 28,2021 were collected,and all patients were pathologically confirmed.All the subjects were treated with traditional Chinese medicine combined with chemotherapy and PD-1antibody.The main end points of disease progression were progression-free survival(PFS)and objective response rate(ORR).Secondary end points were overall survival(OS),KPS,safety and toxicity evaluation.The obtained data were compared with the historical data of NSCLC patients receiving first-line chemotherapy combined with PD-1 antibody to explore the efficacy and safety of traditional Chinese medicine in chemotherapy combined with PD-1antibody in the treatment of advanced NSCLC patients.ResultAll subjects were patients admitted to the Oncology Department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from October 1,2018 to February 28,2021.Follow-up ended on February 1,2021.A total of 80 effective cases were included.1.Primary end points: Median progression-free survival(MPFS)was 8.83 months(95%CI: 7.67-11.07 months);The objective response rate(ORR)and disease control rate(DRC)were 3 2.50% and 81.25%,respectively.2.Secondary end point indicators: overall survival(OS)did not reach the end point;Incidence of adverse reactions: leukopenia of39 cases(48.75%)and low platelet count 34 cases(42.50%),anemia,28 cases(35.00%),of wh ich Ⅲ magnitude of adverse events were 8cases(10%),7 cases(8.75%),8 cases(10%).Wakeness count 16 cases(20.00%),of all were Ⅰ-Ⅱ level.ConclusionIn the treatment of NSCLC with PD-1 antibody combined with chemotherapy,Chinese herbal medicine has a tendency to extend the progression-free survival time,and can reduce some toxicity caused by immunotherapy or chemotherapy drugs,such as bone marrow suppression,skin toxicity,cancer-induced fatigue,etc.,which has a good applicability in improving the survival time and quality of life of patients. |