西妥昔单抗联合卡培他滨与奥沙利铂治疗晚期结直肠癌20例

目的 评价西妥昔单抗联合卡培他滨+奥沙利铂(XELOX方案)治疗晚期结直肠癌的临床疗效与安全性. 方法经病理组织学确诊为晚期结直肠癌患者共40例,分为治疗组和对照组各20例. 对照组单用XELOX方案:奥沙利铂130 mg.(m²)^-1,静脉滴注2 h,第1天,卡培他滨2 000 mg.(m²)^-1,bid,po,第1～14天,每3周重复,共2～4个周期;治疗组XELOX方案＋西妥昔单抗,西妥昔单抗首次给予负荷量400 mg.(m²)^-1静脉滴注2 h,此后每周维持量250 mg.(m²)^-1静脉滴注1 h. 观察其临床疗效与不良反应. 结果 治疗组与对照组总有效分别为12和7例,疾病控制分别为18和14例,中位疾病进展时间分别为7.7与5.4个月,差异均有统计学意义(P<0.05);治疗后主要为Ⅰ或Ⅱ度不良反应,治疗组痤疮样皮疹发生率55.0%. 结论 西妥昔单抗联合XELOX方案治疗老年晚期结直肠癌安全且疗效明显,不良反应能耐受,值得临床进一步研究.

Clinical Observation of Treating 20 Elderly Patients with Advanced Colorectal Cancer in the Regimen of Cetuximab plus XELOX

Objective To evaluate the safety and efficacy of cetuximab combined with capecitabine plus oxaliplatin(XELOX) in treatment of elderly patients with advanced colorectal cancer(ACC).Methods Fourty elderly patients histologically diagnosed as ACC were randomly divided into two groups,20 in the trial group(cetuximab plus XELOX) and 20 in the control group(XELOX regimen).Treatment was capecitabine 2 000 mg·(m2)-1(1 000 mg·(m2)-1 orally twice a day on days 1-14 for 3 weeks,oxaliplatin 130 mg·(m2)-1 intravenously(I.V.) on day 1 every 3 weeks,and cetuximab [initially 400 mg·(m2)-1 I.V.(120 min),subsequently 250 mg·(m2)-1(60 min)].All patients were assessable for the efficacy and toxicity test.Results The overall response was 12 in the trial group and 7 in the control group,the disease control was 18 vs 14,and the median time to progression(TTP) was 7.7 months vs.5.4 months,there were statistically significant differences between two groups(P<0.05).The most frequent grade I/II treatment-related adverse events including diarrhea,nausea/vomiting,neurotoxicity,neutropenia and hand-foot syndrome.Skin rash was observed in 55.0% of the patients in the trial group.Conclusion Cetuximab combined with XELOX regimen is effective,safe and well tolerated in treatment of elderly patients with ACC,and is worth for further study of ACC.