卡培他滨在Ⅲ期结直肠癌一线化疗后维持治疗的临床分析

Efficacy and safety of capecitabine as maintenance treatment after primary chemotherapy using oxaliplatin and capecitabine in stage Ⅲ colorectal cancer

目的评估卡培他滨在Ⅲ期结直肠癌一线化疗后维持治疗的有效性及安全性。方法回顾性分析213例Ⅲ期结直肠癌术后患者的临床及随访资料。以上患者术后接受8周期奥沙利铂联合卡培他滨（XELOX）方案化疗，然后分组：A组（n=76）维持组，B组（n=137）非维持组。比较两组3年无瘤生存率（DFS）、5年总生存率（OS）以及A组维持化疗前后临床不良反应发生率。结果中位随访时间45月。A组3年DFS为62．0％，B组为51．3％（HR=0．6168，95％CI：0．4173—0．9118，P=0．0305），差异有统计学意义。A组5年OS为70．2％，B组为54．5％（HR=0．6502，95％CI：0．4150～1．1090，P=0．0498），差异有统计学意义。A组维持化疗前后的不良反应多数是Ⅰ／Ⅱ级，严重Ⅲ／Ⅳ级不良反应少见。A组和B组两组之间的Ⅰ／Ⅱ级和Ⅲ／Ⅳ级不良反应发生率比较差异无统计学意义（P〉0．05）。结论结直肠癌一线化疗后加单药卡培他滨维持治疗可显著延长患者3年DFS和5年OS，且耐受良好。

Objective To evaluate the efficacy and safety of capecitabine as maintenance treatment agent after primary chemotherapy in stage Ⅲ colorectal cancer. Methods Two-hundred-and-thirteen patients with stage m colorectal cancer were divided into two groups A and B. All patients were given 8 cycles of oxaliplatin and capecitabine （XELOX） as primary chemotherapy. Group A （n = 76） as maintain group and group B （n = 137 ） as nonmaintain group. The 3-year disease free survival（DFS） and 5-year overall survival（OS） rates of two groups and clinical adverse reaction rates before and after maintenance treatment in group A were compared. Results The median follow-up time was 45 months. The 3- year DFS rates of group A and group B were 62.0% and 51.3 % （ HR = 0.6168,95 % CI：0. 4173 - 0.9118, P = O. 0305 ）. The 5-year OS rates were 70.2% and 54.5 % （ HR = 0. 6502,95 % CI ： 0. 4150 - 1. 1090, P = 0. 0498 ）. Before and after maintenance treatment,most adverse reaction was grade Ⅰ/Ⅱ, grade Ⅲ/Ⅳ was not common and there was no significant difference between group A and B （ P 〉 0. 05 ）. Conclusion Maintenance chemotherapy capecitabine can significantly prolong 3-year DFS and 5-year OS patients with stage Ⅲcolorectal cancer after primary chemotherapy and is well tolerated.