Efficacy And Safety Of Apatinib In The Real-world Treatment Of Metastatic Gastric Cancer

ObjectiveTo observe the clinical effects and safety of apatinib in the real-world treatment of metastatic gastric cancer.MethodsThe clinical data of 1000 patients with advanced gastric cancer in Henan region from March 2018 to March 2019,who were treated with apatinib at least 1 cycle were collected.During the treatment,blood routine,liver function,renal function,myocardial enzyme,electrolyte,urine routine,blood pressure level were monitored.CT and/or MRI and other imaging examinations were reviewed every 1 to 2 cycles.If the patient is intolerant and/or has grade 3 or above adverse reactions,adjust the therapy,give symptomatic treatment,reduce the dose,or give other treatments.If disease progression is assessed,or if there are intolerant severe adverse reactions,the drug should be discontinued.Using the Response Evaluation Criteria in Solid Tumors,version 1.1 evaluating the efficacy,and observing the curative effect of apatinib.Recording the related adverse events,then following up the survival of patients.Using SPSS 22.0 software for data statistics,and Kaplan-Meier survival curve for survival analysis.Logistic regression model and Cox proportional-hazards regression model were used to analyze the risk factors influencing ORR,DCR,PFS and OS.P <0.05 indicated difference.Results1.Short-term efficacy evaluation of apatinib: efficacy evaluation was performed in 901 evaluable patients,35 patients achieved complete response(CR),116 patients achieved partial response(PR),596 patients were stable in disease(SD),and 154 patients showed progressive Disease(PD).Therefore,ORR was 16.76% and DCR was as high as 82.91%.Logistic regression model univariate analysis showed that the ORR and DCR of apatinib combination group were better than apatinib single group,and the difference was statistically significant.ORR and DCR were not related to tumor pathological type,number of metastases,history of hypertension,number of apatinib treatment lines and initial treatment dose.2.Long-term efficacy evaluation of apatinib: A total of 1000 patients with advanced gastric cancer were enrolled in this study,December 31,2019 was the last follow-up time.The median PFS and median OS of the total patients were 5.32months(95%CI 4.93～5.75)and 9.76 months(95%CI 8.97～10.81).Cox regression analysis showed that patients with extra gastric metastasis(HR: 1.28,95%CI 1.11～1.48),two metastases above(HR: 1.53,95%CI 1.11～2.13),apatinib third line treatment or above(HR: 1.37,95%CI1.12～1.67),and an initial treatment dose of750mg(HR: 1.93,95%CI 1.26～2.94)had poor prognosis.Patients who received apatinib combination therapy(HR: 0.74,95%CI 0.61～0.90)had a reduced risk of progression,and longer PFS(6.18 months vs 4.47 months,HR:0.74,95%CI 0.61～0.90).In addition,patients with extra gastric metastases(HR: 1.79,95%CI 1.51～2.11),second-line apatinib therapy(HR: 1.41,95%CI 1.12～1.78),third-line apatinib therapy or above(HR: 1.81,95%CI 1.44～2.29)had a higher risk of death,while apatinib as postoperative adjuvant therapy(HR: 0.46,95%CI 0.26～0.83)had a reduced risk of death and apatinib combine with 2 drugs had a longer OS(13.4months vs 7.98 months,HR:0.59,95%CI 0.47～0.74).3.Safety analysis: the main hematological adverse events of apatinib were anemia(67.2%),thrombopenia(36.2%),leukopenia(34.5%).The most common non-hematological adverse events were anorexia(37.6%),fatigue(30.2%),nuasea(29.2%).The most common 3 ～ 4 grade adverse events were neutropenia(9.9%),anemia(8.2%),thrombopenia(4.4%).All adverse events were tolerant after symptomatic and supportive treatment,and there was no treatment-related death.The incidence of all adverse events and grade 3～4 adverse events of apatinib combination therapy were higher than apatinib alone(83.72% vs93.42%,P<0.001,15.28% vs 27.47%,P<0.001).Conclusion1.Apatinib showed promising clinical efficacy and significant survival benefit in the real-world treatment of advanced gastric cancer,and most of the adverse events are manageble.Apatinib is worthy to be widely used and further attention.2.Compared with apatinib alone,apatinib combination therapy can improve the ORR,DCR,PFS and OS of patients,while the incidence of adverse events also increases.In clinical practice,more suitable treatment for patients should be formulated according to the individual conditions.