卡培他滨维持治疗转移性结肠、直肠癌的疗效及安全性观察

Curative effect and safety of capecitabine maintenance treatment in patients with metastatic colorectal cancer

目的评价卡培他滨维持治疗以延长转移性结肠、直肠癌一线化疗后的无疾病进展时间（TTP）的疗效及安全性。方法 50例转移性结肠、直肠癌患者一线化疗后达到稳定,按患者意愿分成2组,治疗组（n=30）给予单药卡培他滨口服,2次/d,餐后服用,2 500 mg/（m2.d）,连续服用14 d后停药7 d,治疗周期为21 d,至少治疗2个周期,直至病情进展或毒性不能耐受;对照组（n=20）采用持续化疗,定期监测,直至病情进展。结果治疗组中位TTP（mTTP）为9.2个月,中位疾病控制时间（mDDC）13.7个月;对照组mTTP为6.1个月,mDDC为9个月,2组mTTP、mDDC差异均有统计学意义。治疗组不良反应多数为Ⅰ~Ⅱ级。结论转移性结肠、直肠癌患者在一线化疗达到稳定后给予单药卡培他滨维持化疗,可显著延长患者TTP,且耐受性良好。

Objective To evaluate therapeutic effect and safety of capecitabine as maintenance treatment agent for prolonging the time to progression（TTP） of patients with metastatic colorectal cancer after they receive first-line chemotherapy.Methods Fifty patients with metastatic colorectal cancer who had stabile disease after chemotherapy were divided into two groups.The treatment group（n=30） was administered capecitabine（twice a day,after meals,2500 mg/m2 daily,withdrawalfor 7 d after a consecutive intake of 14 d,21 d as a cycle,at least 2 cycles） until disease progressed or toxicity could not be tolerated.The control group（n=20） was administered continuous chemotherapy with regular clinical observations until disease progressed.Results The median TTP was 9.2 months in the treatment group and 6.1 months in the control group,while the median time to disease control（mDDC） was 13.7 months in the treatment group and 9 months in the control group.Most of adverse events in the treatment group were grade Ⅰ-Ⅲ.Conclusion Capecitabine as maintenance treatment can significantly prolong the TTP of patients with metastatic colorectal cancer at stable stage after first-line chemotherapy with a better tolerance.