目的比较奥沙利铂联合卡培他滨(XELOX) 方案与奥沙利铂联合氟尿嘧啶/亚叶酸钙(5-FU /LV) (FOLFOX4)方案治疗晚期结直肠癌的近期疗效和不良反应。方法 95例转移或复发晚期结直肠癌患者随机分为两组:奥沙利铂联合卡培他滨组(XELOX组) 47例, 奥沙利铂联合5-FU/LV组(FOLFOX4组) 48例。XELOX 组给予卡培他滨联合奥沙利铂方案化疗, 卡培他滨1000 mg/m², 口服, 2/d, 1～14 d+奥沙利铂130 mg/m², 静脉滴注, d₁;3周重复, 为一疗程。FOLFOX4组给予5-FU、LV 联合奥沙利铂方案化疗, 奥沙利铂85 mg/m², 静脉滴注, +LV 200 mg/m², d₁、d₂, 静脉滴注2 h后+5-FU 400 mg/m², 静脉推注, 后续600 mg/m²持续静脉滴注22 h, d₁、d₂, 2周重复, 4周为一疗程。两组均治疗两个疗程以上。按照RECIST标准评价疗效, 按照NCICTC 3.0评价毒性反应。结果 两组共95例均可评价疗效。XELOX组:完全缓解(CR) 4例, 部分缓解(PR) 19例, 有效率(CR+PR)为48.9%, 疾病控制率(DCR)为85.1%。FOLFOX4组: CR4例, PR20例, 有效率为50.0%, DCR为89.5%。所有不良反应都能耐受, XELOX 组消化道反应、血液学毒性、口腔炎、脱发、高胆红素血症的发生率显著低于FOLFOX4组(P<0.05); 两组周围神经毒性和血小板减少发生率相近; XELOX组的手足综合征发生率明显高于FOLFOX4组(P<0.05) , 但程度较轻, 主要为Ⅰ～Ⅱ度。结论 XELOX 方案与FOLFOX4方案治疗晚期结直肠癌疗效相近, 但XELOX方案用药更为方便, 住院时间短, 更具安全性, 节约住院费用, 值得临床使用。

Objective To compare the efficacy and untoward reactions of capecitabine plus oxaliplatin (XELOX) regimen and oxaliplatin plus 5 - fluorouracil/leucovorin (5-FU/LV) (FOLFOX4) in the treatment of advanced colorectal cancer. Methods Totally 95 patients with metastatic and recurring colorectal cancer were enrolled into this study. Patients were randomly divided into XELOX (n=47) and FOLFOX4 (n=48) groups. Patients in XELOX group were treated with capecitabine 1 000 mg/m², p o, bid, for 14 days, and oxaliplatin 130 mg/m², ivgtt on d 1. Patients in FOLFOX4 group were treated with oxaliplatin 85 mg/m², ivgtt on d 1; LV 200 mg/m² ivgtt for 2 h followed by 5-FU 400 mg/m² (bolus) and 5-FU 600 mg/m² (22 h-coutinous in fusion), on d 1, 2. XELOX regimen was repeated every 3 weeks for one cycle; FOLFOX4 regimen was repeated every 2 weeks, and 4 weeks for one cycle. All patients received two cycles of chemotherapy or more. The toxicity was evaluated according to RECIST criteria, Karnofsky scores and NCICTC 3.O version criteria. Results All the 95 patients were available for evaluating objective response.In XELOX group, the overall response rate was 48. 9% (CR:4, PR:19), the disease control rate was 85.1%.In FOLFOX4 group, the overall response rate was 50.0% (CR:4, PR:20), the disease control rate was 89.5%; the toxicities were well tolerated.In XELOX group, the major side effects were gastrointestinal tract reactions, hematologic toxicity, stomatitis, alopecia; their incidence rates were significantly lower than those in FOLFOX4 group (P<0.05). The peripheral nerve toxicity and thrombocytopenia incidence rates were not significantly different between the two group. The incidence rate of hand-foot syndrome was higher in XELOX group than in FOLFOX4 group (P<0.05), but the severity was less (grade Ⅰ～Ⅱ). Conclusions The response rate is not markedly different between the two regimens.XELOX regimen is safer and its use is more convenient than FOLFOX4 regimen. Therefore, XELOX regimen is worth recommending as a first line therapy for the treatment of advanced colorectal cancer patients.