Efficacy And Safety Of Apatinib Combined With Irinotecan In Patients With Advanced Gastric Cancer

Objective: The purpose of the study was to retrospectively analyze the efficacy of apatinib combined with irinotecan in the treatment of advanced gastric cancer and to observe the safety of two groups.Moreover,this study aimed to explore the predictive effect of adverse events on the therapeutic effect.Methods: Patients with advanced gastric cancer who received apatinib alone or apatinib combined with irinotecan at Department of Oncology in the First Hospital of China Medical University between December 2011 and December 2019 were retrospectively reviewed.The medication time and dosage,adverse events,short-term and long-term survival of patients were collected to compare the efficacy and safety differences between the two groups,and to explore the predictive effect of adverse events on the efficacy.Results: A total of 60 patients with advanced gastric cancer were included in the study,the patients of both apatinib group and apatinib combined with irinotecan group was 30.The efficacy analysis results showed that the objective response rate(ORR)and disease control rate(DCR)in apatinib alone group were 3.33% and 46.67%,respectively,while the ORR and DCR in the combined group were 31.33% and 83.33%,respectively.The ORR(P<0.001)and DCR(P=0.003)in the combined group were significantly better than that of the apatinib group,indicating that apatinib combined with irinotecan had a better efficacy compared with apatinib alone.The survival analysis showed that median progression-free survival(PFS)and median overall survival(OS)in apatinib group were 2.53 months(95% CI,1.46 to 3.60)and 5.30 months(95% CI,2.90 to 7.70),respectively,while the median PFS and median OS in combined group were 4.27 months(95% CI,2.97 to 5.57)and 9.80 months(95% CI,6.44 to 13.16),respectively.The PFS and OS in the combined group were longer than that in apatinib group,indicating that apatinib combined with irinotecan had a longer survival compared with apatinib alone.The safety analysis showed that the adverse effects in both apatinib group and combined group were slight and manageable.Furthermore,the incidence of myelo-suppression(P=0.001)and diarrhea(P=0.016)in the combined group was higher than that in apatinib group.When the starting dose of apatinib in apatinib group was 500 mg and in the combined group was 250 mg,the dose was safe and effective.Moreover,in terms of the predictive effect of adverse effects on the efficacy,there was no significant difference between the efficacy of patients with proteinuria,hypertension or hand-foot-skin reaction(HFSR)in the first 4 weeks in apatinib treatment and those without such adverse effects(P>0.050),and there was no significant difference between the efficacy of patients with proteinuria,hypertension or HFSR in the first two cycles of apatinib combined with irinotecan treatment and those without such adverse effects(P>0.050).No adverse effects that could predict efficacy in neither apatinib group nor apatinib combined with irinotecan group.Conclusion: In the second-line and third-line therapy plans applied in advanced gastric cancer clinically,apatinib combined with irinotecan can increase efficacy,prolong PFS and OS compared with apatinib alone.The adverse events in both apatinib group and apatinib combined with irinotecan group were tolerable and manageable.The incidence of myelo-suppression and diarrhea in the combined group was higher than that in the apatinib group.When the dose intensity of apatinib was 500 mg in the monotherapy group and 250 mg in apatinib combined with irinotecan group,the dose was safe and effective.