XELOX方案与FOLFOX4方案治疗转移性结直肠癌的临床观察

Clinical study of capecitabine plus oxaliplatin compared with 5-fluorouracil/ leucovorin (LV5FU2) plus oxaliplatin in the treatment of metastatic colorectal cancer

目的:观察两种常用化疗方案卡培他滨联合奥沙利铂方案(XELOX)与5-氟尿嘧啶/亚叶酸钙联合奥沙利铂方案(FOLFOX4)治疗转移性结直肠癌的临床疗效及不良反应。方法:48例晚期结直肠癌患者随机分成两组,XELOX组与FOLFOX4组。XELOX组25例,予卡培他滨联合奥沙利铂方案化疗,卡培他滨1000mg/m2,口服,2次/日,第1-14天;奥沙利铂130mg/m2,静脉点滴,第1天;21天1周期。FOLFOX4组23例,予5-氟尿嘧啶,亚叶酸钙联合奥沙利铂方案化疗,奥沙利铂85mg/m2,静脉点滴,第1天;亚叶酸钙200mg/m2,静滴2小时后予5-氟尿嘧啶400mg/m2,推注,后续600mg/m2持续静滴22小时,第1、2天;每2周重复,4周为1周期。两组均治疗2周期以上。按WHO标准评价客观疗效和不良反应。结果:48例均可评价疗效,XELOX组有效率48.0%(CR2,PR10),中位TTP7.1个月,MST13.8个月,FOLFOX4组有效率47.8%(CR2,PR9),中位TTP7.3个月,MST14.0个月。两组近期有效率无明显统计学差异。不良反应比较,手足综合征以XELOX组显著(P<0.05),Ⅲ-Ⅳ级恶心呕吐发生率FOLFOX4组高(P<0.05),余不良反应除腹泻外发生率以FOLFOX4组稍高,但无统计学意义。结论:XELOX方案与FOLFOX4方案治疗晚期结直肠癌疗效确切,不良反应能耐受。两组近期疗效相似,不良反应XELOX组更低。

Objective：To evaluate the efficacy and toxicity of capecitabine plus oxaliplatin regimen （XELOX） versus 5 -fluorouraciLeleucovorin （LVSFU2） plus oxaliplatin regimen （FOLFOX4） in the treatment of metastatic colorectal cancer. Methods ： Total of 48 cases with metastatic colorectal cancer were enrolled into this study,25 patients and 23 patients were randomly divided into XELOX group and FOLFOX4 group respectively. XELOX group was treated with capecitabine 1000mg/m^2 d,po,Bid,d1-14 ;oxaliplatin 130 mg/m^2 d,ivgtt,d1. FOLFOX4 group was treated with oxaliplatin 85 mg/m^2 d,ivgtt, dt ;LV 200 mg/m^2 ivgtt 2h followed by 5 - FU 400 mg/m^2 （bolus） and 5 -FU 600 mg/m^2 （22h - coutinous infusion）. XELOX regimen was repeated every 3 weeks for one cycle, FOLFOX4 regimen was repeated every 2 weeks ,4 weeks for one cycle. All patients received two cycles of chemotherapy at least. The efficacy and toxicity were evaluated according to WHO standard. Results： All 48 cases were available for objective response. The overall response rate was 48.0% （ CR2, PR10） in XELOX group of 25 cases and 47.8% （ CR2, PR9 ） in FOLFOX4 group of 23 cases. The difference in response rate was not statistically significant between the two groups （ P 〉 0.05 ）. The median time to progression （mTTP） was 7.1 months in XELOX group and 7.3 months in FOLFOX4 group. The median survival time （MST） was 13.8 months in XELOX group and 14.0 months in FOLFOX4 group. The incidence of grade Ⅲ＋ Ⅳnausea and vomiting was significantly lower in XELOX group than in FOLFOX4 group （P 〈 0.05 ） but hand and foot syndrome in XELOX group were more obvious than in FOLFOX4 group （ P 〈 0.05 ）, Incidence of other side effects in FOLFOX4 group was higher than that of those in XELOX group except for diarrhea, but no significance existed （P 〉 0.05 ）. Conclusion： Both of the two regimens were feasible, well tolerated and effective in the treatment of metastatic colorectal cancer. XELOX regimen may be safer than FOLFOX4 regimen.