A Clinical Study Of Anrotinib Hydrochloride Combined With Aidi Injection In Patients With Advanced Or Recurrent Non-small Cell Lung After Second-line Treatment

1.ObjectiveTo observe and explore the clinical efficacy and safety of androtinib hydrochloride combined with Aidi injection for advanced non-small cell lung cancer patients who have failed second-line therapy.To determine whether the treatment of Aidi injection combined with androtinib hydrochloride has the effect of reducing toxicity and increasing efficiency.And clarify the advantages and necessity of traditional Chinese medicine in the course of vascular targeting therapy of non-small cell lung cancer.2.MethodsFrom March 2021 to October 2021,Eighty patients who met the inclusion criteria in Tianjin University of Traditional Chinese Medicine were divided into the experimental group and the control group in a 1:1 ratio by simple randomization method for prospective study.The control group received anlotinib hydrochloride(trade name: fukewei,Jiangsu Chia Tai-Tianqing Pharmaceutical Co.,Ltd.specification: 12 mg / capsule)12mg oral before breakfast d1-14 q3 w,while the experimental group was treated with Aidi injection(Guizhou Yibai Pharmaceutical Co.,Ltd.,specification: 10 ml / piece)80ml ivdrip Qd d1-7 q3 w on the foundation.Treatment should continue for at least 6 courses.The main outcome measures were PFS,DCR,ORR.The secondary outcome measures were Hamilton Depression Scale score,Pfs-r rating scale,TCM syndrome score,KPS,Serum tumor marker levels,safety evaluation.3.ResultsA total of 80 patients were included in the study,41 in the experimental group and 39 in the control group.There was no significant difference in m PFS between the two groups(7.40 months vs.6.62 months).The ORR of experimental group was 12.20%,and that of control group was 7.69%,with no statistical significance(P>0.05).The DCR of experimental group was 63.41%,and that of control group was 41.03%,the difference was statistically significant(P<0.05).In terms of reducing the level of tumor markers,CEA and CYFRA21-1 levels in 2groups were decreased compared with before treatment,and the difference was statistically significant(P<0.05).In terms of improving the quality of life,the experimental group could decrease the PFS-R score,Hamilton depression Scale score,TCM syndrome score(P<0.05),and improve the KPS score(P<0.05).The incidence of adverse reactions in the experimental group was less than the control group in diarrhea,Leukopenia and aglobuliosis(P<0.05).Stratified analysis of PFS: The dominant population in this study was patients with age <65,adenocarcinoma,stage Ⅲ and treatment period >8.COX regression analysis showed that stage Ⅲ and long period(>8)treatment were the protective factors affecting the prognosis of PFS.4.ConclusionAnlotinib hydrochloride combined with Aidi injection for treatment of advanced NSCLC can improve clinical efficacy and ORR of patients;It can improve fatigue and depression,relieve TCM clinical symptoms and reduce adverse reaction events.Meanwhile,the serum CEA and CYFRA21-1 levels were decreased,and tumor growth was inhibited,which played a role in reducing toxicity and increasing efficiency.