单用吉奥及阿帕替尼二线治疗晚期胃癌伴肝转移临床对比研究

Clinical comparative study of tegio and apatinib for second-line monotherapy regimens in the treatment of patients with advanced gastric cancer combined with liver metastases

目的:探讨单用替吉奥与阿帕替尼二线治疗晚期胃癌伴肝转移临床疗效及安全性差异。方法:研究对象选取晚期胃癌伴肝转移规范一线化疗失败后患者共130例,以随机数字表法分为对照组(65例)和观察组(65例),分别行单用替吉奥和阿帕替尼进行二线治疗;比较2组客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、中位无进展生存期(progression-free survival,PFS)、中位总生存期(overall survival,OS)、治疗前后血管内皮生长因子(vascular endothelial growth factor,VEGF)、基质金属蛋白酶9(matrix metalloproteinase-9,MMP-9)、白细胞计数(white blood cell count,WBC)、血小板计数(platelet count,PLT)水平及不良反应发生率。结果:观察组ORR和DCR均显著高于对照组(P<0.05);观察组中位PFS和OS均显著长于对照组(P<0.05);观察组治疗后VEGF和MMP-9水平均显著低于对照组和治疗前(P<0. 05);观察组治疗后WBC和PLT水平均显著高于对照组(P<0.05);2组恶心呕吐发生率比较差异无统计学意义(P>0.05);观察组Ⅰ~Ⅱ级腹泻、皮肤过敏及口腔炎发生率均显著低于对照组(P<0.05);但观察组Ⅰ~Ⅱ级手足综合征和血压异常升高发生率均显著高于对照组(P<0.05)。结论:与替吉奥相比,阿帕替尼单用二线治疗晚期胃癌伴肝转移可有效延缓病情进展,提高生存率,降低MMP-9和VEGF水平,减轻骨髓抑制程度,并有助于避免腹泻、皮肤过敏及口腔炎发生,但也可能导致手足综合征和血压异常升高。

Objective:To investigate the clinical effects and safety of tegio and apatinib second-line monotherapy regimens in the treatment of advanced gastric cancer patients with liver metastases.Methods:Totally 130 advanced gastric cancer patients with liver metastases after failure of standard first-line chemotherapy were selected and randomly divided into control group(65 cases)and experimental group(65 cases).Tigeo and apatinib were used for second-line treatment respectively.The objective response rate(ORR),disease control rate(DCR),progressive-free survival(PFS),overall survival(OS),vascular endothelial growth factor(VEGF),matrix metalloproteinase-9(MMP-9),white blood cell count(WBC),platelet count(PLT)before and after treatment,the incidence of adverse reactions were compared between the two groups.Results:The ORR and DCR of experimental group were significantly higher than control group(P<0.05).The median PFS and OS of experimental group were significantly longer than control group(P<0.05).The levels of MMP-9 and VEGF levels after treatment in experimental groups were significantly lower than control group and before treatment(P<0.05).The levels of WBC and PLT after treatment in experimental groups were significantly higher than control group(P<0.05).There was no significant difference in the incidence of nausea and vomiting between the two groups(P>0.05);the incidence of gradeⅠ-Ⅱdiarrhea,skin allergy and stomatitis in the experimental group was significantly lower than that in the control group(P<0.05);but the incidence of gradeⅠ-Ⅱhand-foot syndrome and abnormal elevation of blood pressure in the experimental group was significantly higher than that in the control group(P<0.05).Conclusion:Compared with tegio,apatinib alone can effectively delay the progression of advanced gastric cancer patients with liver metastasis,improve survival rate,reduce the levels of MMP-9 and VEGF,reduce the degree of bone marrow suppression,and help to avoid diarrhea,skin allergies and stomatitis,but it may also lead to hand-foot syndrome and abnormal blood pressure rise.