Clinical Observation Of 54 Patients With Advanced Malignant Tumor Treated By Immunocheckpoint Inhibitor Combined With Traditional Chinese Medicine

Purpose of the Investigation: To observe the clinical efficacy of checkpoint inhibitors combined with Traditional Chinese medicine in the treatment of advanced malignant tumor patients and the immune-related adverse events(ir AEs).?Methods of the Investigation: Selection in April 2018 to January 2020 in the first affiliated hospital of anhui medical university during the cooperation of Chinese and western medicine oncology immune checkpoint inhibitors combined traditional Chinese medicine therapy and treatment for more than 4 cycles in installment ? malignant tumor patients,retrospective study,to observe the symptom and clinical curative effect of traditional Chinese medicine,summarize ir AEs type,rate,level and the median time occurs.Results: 1.Syndrome types: Among the 54 patients who received Chinese medicine combined with ICIs treatment,the patients mainly showed three syndrome types,including 25 cases of qi and Yin deficiency syndrome(46.3%),15 cases of liver depression and spleen deficiency syndrome(27.8%),and 14 cases of internal resistance syndrome(25.9%).After using Traditional Chinese medicine,the effective rate of improvement of qi and Yin deficiency syndrome was 84%,that of liver depression and spleen deficiency syndrome was 80%,and that of blood stasis and toxin resistance syndrome was 79%.2.The clinical curative effect: in the 54 cases of patients,treated by traditional Chinese medicine combined with ICIs plan more than 4 cycles,immune complete remission(i CR)have 1 case,immune partial response(i PR)in 8 cases,immune stability(i SD)in 32 cases,has formally disease development(i CPD)in 13 cases,objective response rate(ORR)was 17%,the rate of clinical benefit(DCR)was 76%.3.Ir AEs aspects:(1)IrAEs types: including hypothyroidism,skin rash,cardiac toxicity,immune-related hepatitis,immune-related pneumonia and immune-related nephritis;(2)Incidence of Ir AEs: The total incidence of Ir AEs was 40.7%,the highest incidence of endocrine toxicity was 20.3%,the highest incidence of rash was 9.3%,the highest incidence of immune-related myocarditis and immune-related hepatitis were 3.8%,the highest incidence of immune-related pneumonia and immune-related nephritis were 1.9%;The incidence of ir AEs was 36% for qi and Yin deficiency syndrome,40% for silt-poison internal resistance syndrome,and 50% for liver depression and spleen deficiency syndrome.(3)Ir AEs grade: G1-G2 was the main type,accounting for 90.9%,and G3-G4 for 9.1%,but the risk was high and life risk was very likely to occur.(4)Median occurrence time of Ir AEs: the median occurrence time of endocrine toxicity,skin toxicity,cardiac toxicity,and immune-related hepatitis was 3.1 months,2.3 months,3.4 months,and 4 months,respectively;the median occurrence time of other Ir AEs was not counted due to the small number of cases.Conclusion: 1.The TCM syndromes of advanced malignant tumor patients treated with immune checkpoint inhibitors are mixed with deficiency and excess,mainly manifested as deficiency of qi and Yin,deficiency of liver qi and spleen,and internal resistance of stasis and toxin.TCM therapy can be used to enrich Qi and nourish Yin,soothe liver and regulate qi,and detoxify and clear collaterals.And can obviously improve the patient's TCM symptoms.2.In patients with advanced malignant tumor treated with TCM combined with ICIs,the clinical benefit rate is high and the tumor progression can be delayed.3.In patients with advanced malignant tumors,there are many types of Ir AEs,which may involve multiple systems of the human body,of which endocrine toxicity and skin toxicity are the most common.Of all the patients treated with ICIs,the type of internal resistance to siltation had the highest incidence of adverse reactions and could be a potential predictor for clinical practice.4.Patients with late malignant tumor in the process of ICIs therapy,cooperate with Chinese medicine treatment,various types of ir AEs incidence and toxicity of the literature reported lower grade,adverse reactions occurred in a prolonged,suggests to reduce the incidence of ir AEs,adverse reactions of traditional Chinese medicine grade,extend a time to have a certain role in adverse reactions occur,for patients with advanced malignant treatment time,worth clinical promotion.