出 处:《浙江医学》2020年第15期1609-1613,共5页Zhejiang Medical Journal
基 金:嘉兴市科技局项目(2019AD32254)。
摘 要:目的探讨不同剂量卡培他滨单药化疗在老年高危Ⅱ期及Ⅲ期大肠癌患者术后辅助化疗中应用的安全性及长期疗效。方法选择2015年1月至2017年12月在嘉兴学院附属第二医院手术的高危Ⅱ期及Ⅲ期老年(年龄≥70岁)大肠癌患者137例,采用随机数字表法分为3组:低剂量组[卡培他滨2000 mg/(m^2·d),45例]、常规剂量组[卡培他滨2500 mg/(m^2·d),46例]、对照组(不化疗,46例)。比较3组的一般资料,比较低剂量组和常规剂量组的化疗完成率、化疗不良反应(包括恶心、呕吐、肝功能损伤、蛋白尿、骨髓抑制、手足综合征)。通过随访,采用Kaplan-Meier法绘制生存曲线,比较3组患者的无病生存期和3年无病生存率(DFS)。针对肿瘤的分期进行亚组分析,分别比较3组中高危Ⅱ期和Ⅲ期患者的无病生存期和3年DFS。结果3组患者的一般资料比较差异无统计学意义(P>0.05),低剂量组和常规剂量组的化疗完成率比较差异均无统计学意义(均P>0.05)。低剂量组恶心、呕吐的发生率和严重程度均低于常规剂量组,差异有统计学意义(P<0.05)。两组肝功能损伤、蛋白尿、骨髓抑制、手足综合征等不良反应比较差异均无统计学意义(均P>0.05)。低剂量组、常规剂量组和对照组的中位无病生存期分别为46.4个月、46.9个月、41.2个月,3年DFS分别为73.0%、79.4%、53.3%,差异有统计学意义(P<0.05)。亚组分析发现,对于高危Ⅱ期患者,3组的中位无病生存期分别为47.9个月、47.3个月、45.1个月,3年DFS分别为84.6%、76.6%、71.6%,差异无统计学意义(P>0.05)。对于Ⅲ期患者,3组的中位无病生存期分别为43.2个月、46.3个月、38.7个月,3年DFS分别为72.4%、79.7%、48.0%,差异有统计学意义(P<0.05)。结论对于70岁以上的高危Ⅱ期大肠癌患者,不建议卡培他滨单药辅助化疗;对于70岁以上的Ⅲ期大肠癌患者,应用低剂量卡培他滨单药辅助化疗更安全,且能获得与常�Objective To investigate the safety and long-term efficacy of different doses of capecitabine in post-operative adjuvant chemotherapy for aged patients(age≧70)with high-risk stageⅡand stageⅢcolorectal cancer.Methods Between January 2015 and December 2017,137 eligible cases were included,who were randomly divided into low-dose group(capecitabine 2000mg/m2·d,n=45),regular-dose group(capecitabine 2500mg/m2·d,n=46)and control group(no chemotherapy,n=46).Demographic data was compared between the three groups,and completion rate of chemotherapy and adverse reactions of chemotherapy(including nausea and vomiting,liver function damage,proteinuria,bone marrow suppression,hand foot syndrome)were compared between low-dose and regular-dose groups.After follow-up,the survival curve was drawn with Kaplan-Meier method to compare disease-free survival(DFS)periods and three-year DFS rate among three groups;and subgroup analysis was also performed to identify specific beneficiaries of adjuvant chemotherapy.Results There were no significant differences in demographic data among three groups(P>0.05);and no significant differences in rate of chemotherapy completion between low-dose and regular-dose groups(P>0.05).The incidence of nausea and vomiting was lower in low-dose group than that in regular-dose group(P<0.05),but there were no significant differences in the incidence of liver function injury,proteinuria,bone marrow inhibition and hand-foot syndrome between low-dose and regular-dose groups(P>0.05).The DFS periods of low-dose,regular-dose and control groups were 46.4m,46.9m and 41.2m,and the three-year DFS rate were 73.0%,79.4%and 53.3%,respectively(P<0.05).The sub-group analysis found that the DFS period was 47.9m,47.3mand 45.1mfor patients with high-risk stageⅡin low-dose,regular-dose and control groups;and the three-year DFS rate was 84.6%,76.6%and 71.6%,respectively(P>0.05).For patients with stageⅢin the three groups,the DFS period was 43.2m,46.3mand 38.7m,and the three-year DFS rate was 72.4%,79.7%and 48.0%,resp
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