替吉奥在晚期肺腺癌伴野生型表皮生长因子受体基因患者维持治疗中的有效性及安全性研究

摘要

目的 探讨替吉奥在晚期肺腺癌伴野生型表皮生长因子受体(EGFR)基因患者维持治疗中的有效性及安全性.方法 选取2013年10月—2015年11月郑州大学附属肿瘤医院收治的晚期肺腺癌伴野生型EGFR基因患者81例,均接受标准一线培美曲塞+卡铂化疗6个周期且疾病稳定或部分缓解,采用随机数字表法分为培美曲塞组51例,替吉奥组30例.培美曲塞组患者给予培美曲塞进行维持治疗,替吉奥组患者给予替吉奥进行维持治疗;两组患者均化疗2个周期或至疾病进展.比较两组患者临床疗效、毒副作用发生情况,记录两组患者无进展生存时间,并绘制Kaplan-Meier生存曲线以分析两组患者生存情况.结果 两组患者临床疗效比较,差异无统计学意义(P>0.05).替吉奥组患者骨髓抑制、恶心呕吐发生率高于培美曲塞组(P<0.05);而两组患者肝功能损伤、腹泻发生率比较,差异无统计学意义(P>0.05).培美曲塞组患者中位无进展生存时间为5.5个月〔95％CI(4.8,6.2)〕,替吉奥组为4.0个月〔95％CI(3.2,4.8)〕.两组患者Kaplan-Meier生存曲线比较,差异无统计学意义(P>0.05).结论 替吉奥与培美曲塞在晚期肺腺癌伴野生型EGFR基因患者维持治疗中的有效性相似,均可有效延长患者中位无进展生存时间,且经口服用方便,但可能增加骨髓抑制、恶心呕吐发生风险.%Objective To investigate the effectiveness and safety of Tegafur,Gimeracil and Oteracil Porassium Capsules in maintenance therapy for advanced pulmonary adenocarcinoma patients with wild type EGFR gene.Methods A total of 81 advanced pulmonary adenocarcinoma patients with wild type EGFR gene were selected in Cancer Hospital Affiliated to Zhengzhou University from October 2013 to November 2015,all of them received standard first-line chemotherapy (pemetrexed+carboplatin) for 6 cycles and reached to stable disease or partial remission,and they were divided into A group (n=51)and B group(n=30)according to random number table. Patients in A group received pemetrexed for maintenance therapy,while patients in B group received Tegafur,Gimeracil and Oteracil Porassium Capsules for maintenance therapy;both groups continuously treated for 2 cycles or till to disease progression. Clinical effect,incidence of toxic and side effects were comparative between the two groups,progression-free survival time was recorded,and Kaplan-Meier survivorship curve was drawn to analyze the survival status.Results No statistically significant differences of clinical effect was found between the twogroups(P>0.05). Incidence of myelosuppression,nausea and vomiting in B group was statistically significantly higher than that in A group,respectively(P<0.05);while no statistically significant differences of incidence of hepatic injury or diarrhea was found between the two groups(P>0.05). Median progression-free survival time in A group was 5.5 months〔95％CI(4.8, 6.2)〕,that in B group was 4.0 months〔95％CI(3.2,4.8)〕. No statistically significant of Kaplan-Meier survivorship curve was found between the two groups(P>0.05).Conclusion Tegafur,Gimeracil and Oteracil Porassium Capsules has similar effectiveness with pemetrexed in the maintenance therapy for advanced pulmonary adenocarcinoma patients with wild type EGFR gene,can effectively lengthen the median progression-free survival time,and oral administration is convenient,but may increase the risk of myelosuppression,nausea and vomiting.