| BackgroundLung cancer is a common malignant tumor,and the mortality rate ranks first in cancer,which accounts for 17.1% and 21.7% of all malignant tumors respectively.The most common subtype of lung cancer is non-small cell lung cancer(NSCLC),which constitutes about 80% to 85% of all lung cancers.Approximately75% of NSCLCare advanced at diagnosis,and the 5 year survival rate is less than18%.At present,chemotherapy and radiotherapy are main treatments of advanced lung cancer,but these therapeutic methods are not satisfying in improving the quality of life and survival of the patients.In recent years,targeted anti-tumor drugs have been continuously explored and breakthroughs have been made.This has brought hope to patients with non-small cell lung cancer.Targeted therapy is a treatment for cellular signal transduction and other biological pathways during the development and progression of malignant tumors.It targets tumor-associated molecules and directly suppress the growth and metastatsis of tumors by acting on specific targets.Wait for the process.At present,the accurate treatment of targeted drugs have been applied to the clinic to improve the therapeutic effect of non-small cell lung cancer and prolong the life span of the patients.For example,monoclonal antibodies and small molecule kinase inhibitors allow individualization and specializition of anti-tumor therapy to become the norm.And antiangiogenic drugs targeting tumor neovascularization have become a research hotspot in recent years.Apatinib is a small-molecule tyrosine kinase inhibitor that was independently developed in China and approved by the China Food and Drug Administration(CFDA)in 2014 for the treatment of adenocarcinoma of the gastroesophageal junction with advanced gastric cancer.The mechanism of action is highly selective inhibition of vascular endothelial growth factor receptor-2(VEGFR-2),blocking intracellular signal transduction after VEGF binding to its receptor,thereby inhibiting tumor angiogenesis and achieving anti-tumor effects.At present,the recommended dosage of apatinib is 0.85 g,and a number of clinical trials indicate that usage of 0.85 g in solid tumors has high incidence of adverse reactions.It was mentioned in the expert consensus of clinical application of apatinib in the treatment of gastric cancer that in order to ensure its safety and improved compliance we can reduce the initial dose appropriately.There are few reports about the monotherapy and the effective low dose of apatinib in Chinese people.What’s more reports of patients with PS of 3 score are few.However,these patients are not uncommon in clinical practice,especially for advanced lung cancer patients with second-line treatment failure and driver gene wild type,and current treatment methods for these patients are limited.This study will investigate the clinical efficacy and safety of apatinib in advanced non-small cell lung cancer patients who fail second-line chemotherapy,have PS of 3 score,and driver gene wild type.ObjectiveTo oabserve the effect of apatinib on three-line treatment for patients with driver gene(including EGFR,ALK,and ROS1)wild type,PS of 3 score,advanced non-small-cell lung cancer.MethodsThere are fifty-six patients in treatment group who had been diagnosed with pathological histology or cytology and failed second-line chemotherapy and had PS of 3 score with advanced non-small-cell lung cancer received monotherapy of apatinib at a dose of 250mg/QD,and maintained the therapy.Every 4 weeks for a period of treatment until the progression of the disease or intolerable adverse reactions.And another thirty patients with advanced non-small-cell lung cancer in the control group,this patients were only given best supportive care after the failure of second-line chemotherapy.The efficacy was evaluated by the imaging,and the median progression-free survival(PFS),median overall survival(OS),the incidence rate of adverse reaction before and after treatment.ResultsThere were no significant differences of the age,gender,TNM staging,pathological type between the treatment group and control group.In the treatment group,the median age was 61(41-78)years old and all data can be analyzed.The clinical evaluation of the patients were complete remission(CR)0 case,partial remission(PR)5 cases,steady(SD)30 cases and progress(PD)21 cases.The objective response rate(ORR)was 8.9%(5/56),disease control rate(DCR)was62.5%(35/56).Besides,the incidence rate of adverse reaction was low,there was no serious adverse reaction.The main toxicities were hypertension(9,16.1%),hand-foot syndrome(7,12.5%),proteinuria(6,10.7%)and bone marrow suppression(5,8.9%).The median progression-free survival(PFS)was 3.6 months and the median overall survival(OS)was 6.5 months.In the control group,the clinical evaluation of the patients were complete remission(CR)0 case,partial remission(PR)0 cases,steady(SD)9 cases and progress(PD)21 cases.The objective response rate(ORR)was 0%(0/30),disease control rate(DCR)was 30.0%(9/30).The main toxicities were fatigue(15/30,50.0%),appetite dropping(16/30,53.3%).The median PFS and median OS was 2.0m and 4.4m.Univariate analysis of the treatment group showed that the degree of adverse reactions after taking apatinib were related to the prognosis of the patients;Gender,age,tumor stage and pathological type were not related to prognosis.ConclusionApatinib can prolong PFS and OS,and the adverse reaction rate was low with low-dose 250mg/QD treatment in patients with advanced non-small-cell lung cancer,who are second-line chemotherapy failure and PS of 3 score and driver gene(including EGFR,ALK,and ROS1)wild type.It is worthy of further clinical research and application. |
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