【摘要】 目的观察替吉奥对SOX或DCF方案一线化疗后的晚期胃癌患者维持治疗的疗效、临床获益率及不良反应。方法收集2013年1月~2016年1月汕头市中心医院诊治的经影像学和病理学确诊为晚期胃癌患者,经DCF或SOX方案诱导化疗4~6个周期,疗效为部分缓解(PR)或稳定(SD)的患者62例,随机分为替吉奥维持组和观察组。替吉奥维持治疗组按体表面积给药,每21天为1个周期,2~4个周期复查一次CT或MRI进行一次疗效评估,维持化疗持续到出现疾病进展或不可耐受的不良反应为止。观察组予以护胃等对症治疗,6~8周复查一次CT或MRI进行一次疗效评估,疾病进展后接受二线化疗。结果替吉奥维持治疗组临床缓解率RR(CR+PR)为40%(12/30),疾病控制率DCR(CR+PR+SD)为73.3%(22/30)。观察组临床缓解率RR(CR+PR)为15.6%(5/32),疾病控制率DCR(CR+PR+SD)为40.6%(13/32)。两组疗效比较,维持治疗组明显好于观察组(P<0.05)。维持化疗组和观察组的无疾病进展时间分别为8.3个月(95%CI:6.167~9.486)、6.0个月(95%CI:4.236~6.951),两组比较差异有统计学意义(P<0.05)。维持化疗组和观察组的总生存时间分别是12.87个月,(95%CI:11.541~14.213)、10.8个月(95%CI:9.936~11.651),两组比较差异统有计学意义(P<0.05)。1年生存率分别为40.0%(12/30)、25.0%(8/32),两组比较差异有统计学意义(P<0.05);替吉奥维持组主要不良反应有白细胞减少、贫血、恶心呕吐、疲乏、口腔黏膜炎、手足综合征等,未发生治疗相关死亡事件。结论晚期胃癌患者经DCF或SOX方案一线化疗后继续予以替吉奥维持治疗,可以提高临床缓解率和疾病控制率,延缓疾病进展,提高总生存时间,不良反应可以耐受,值得在临床实践中研究推广。更多还原

【Abstract】 Objective To discuss the clinical efficacy, clinical benefit rate and adverse reaction of SOX or DCE first-line chemotherapy combined with Tegafur Gimeracil and Oteracil Potassium Capsules maintenance therapy for advanced gastric cancer. Methods Selected 62 cases with advanced gastric cancer from Jan 2013 to Jan 2016 underwent SOX or DCE chemotherapy for 4-6 cycles with clinical efficacy of PR or SD were randomly divided into Tegafur, Gimeracil and Oteracil Potassium Capsules Maintenance therapy group and the control group. The Tegafur,Gimeracil and Oteracil Potassium Capsules Maintenance therapy group was administered according to body surface area, 21 d per circle, and was reviewed with CT or MRI after 2-4 circles for clinical efficacy valuation. The chemotherapy continued until disease progression or intolerance of adverse effects. The control group receive protective stomach therapy, and was reviewed with CT or MRI after 6-8 weeks for clinical efficacy valuation, and after disease progression, received second-line chemotherapy. Results RR(CR+PR)of the Tegafur,Gimeracil and Oteracil Potassium Capsules maintenance therapy group was 40%(12/30), DCR(CR+PR+SD) was 73.3%(22/30). RR(CR+PR)of the control group was 15.6%(5/32), and DCR(CR+PR+SD) was 40.6%(13/32). Compared with two groups, the tegafur,gimeracil and oteracil potassium capsules maintenance therapy group was better(P < 0.05). No disease progression time of the e Tegafur, Gimeracil and Oteracil Potassium Capsules maintenance therapy group and the control were 8.3 months(95%CI:6.167-9.486) and 6.0 months(95%CI:4.236-6.951), which showed significant difference(P < 0.05). Total survival time of the tegafur,gimeracil and oteracil potassium capsules maintenance therapy group and the control were 12.87 months(95%CI:11.541-14.213) and 10.8 months(95%CI:9.936-11.651),which showed significant difference(P < 0.05). 1 year survival rates of the e Tegafur,Gimeracil and Oteracil Potassium Capsules maintenance therapy group and the control were 40.0%(12/30) and 25.0%(8/32), which showed significant difference(P < 0.05). Adverse reactions of the Tegafur, Gimeracil and Oteracil Potassium Capsules maintenance therapy group were aleukocytosis, anemia, nausea, vomiting, fatigue, oral mucositis, hand foot syndrome and so on, and no treatment-related deaths occurred. Conclusion SOX or DCE first-line chemotherapy combined with Tegafur, Gimeracil and Oteracil Potassium Capsules maintenance therapy for advanced gastric cancer improve clinical remission rate and disease control rate, delay disease progression and increase overall survival time, with tolerable adverse reactions, worthy of clinical promotion.更多还原