摘要
目的:比较奥沙利铂(oxaliplatin OXA)联合卡培他滨(capecitabine CAPE)方案(XELOX)与奥沙利铂联合氟尿嘧啶/亚叶酸钙(FOLFOX4)方案治疗的晚期结直肠癌的近期疗效,不良反应和生存时间。方法:43倒晚期结直肠癌患者随机分成XELOX组与FOLFOX4组。XELOX组20例,CAPE1000mg/m^2。口服,2次/日,第1—14天;OXA130mg/m^2,静脉点滴,第1天;3周为1周期。FOLFOX4组23例,予OXA85mg/m^2,静脉点滴,第1天:Cg200mg/m^2.静滴2小时后予5-FU400mg/m^2,推注,后续600rag/m^2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周期后按RECIST标准评价客观疗效,NCI常用毒性标准(CTC3.0)抗癌药毒性分度标准评价不良反应。结果:43例患者均可评价疗效,XELOX组20例,CR2例。PR7例。SD4例,PD67例。总有效率(RR)45.0%(CR+PR),疾病控制率(DCR)65.0%(CR+PR+SD);FOLFOx4组23例,CR3例,PR7例。sD6例,PD7例。RR为43.5%,DCR为67.9%。XELOX组mTTP7.1月;FOLFOX4组mTTP7.0个月。两组有效率无统计学差异(x^2=0.102,P〉0.05)。不良反应XELOX组手足综合征较高(P〈0.05),FOLFOX4组外周静脉炎较高(P〈0.05),余不良反应均无统计学意义。结论:XELOX方案与FOLFOX4方案治疗晚期结直肠癌近期疗效相似,化疗不良反应XELOX组较轻,使用更为方便。
Objective: To evaluate the efficacy and toxicity of capecitabine plus oxaliplatin regiman (XELOX)versus 5 - fluorouracil / hucovofin (LVSFU2) plus oxaliplafin regimen (FOLFOX4) in the treatment of metastatic calorectal cancer. Methods: Total of 43 cases with metastatic colorectal cancer were enrolled into this study, 20 patients and 23 patients were randomly divided into XELOX group and FOLFOX4 group respectively. XELOX group was treated with capecitabine 1000rag/m2 d, po, Bid, dl- 14 ; oxaliplatin 130 mg/m^2 d, ivgtt, dl. FOLFOX4 group was treated with oxaliplatin 85 mag/m^2 d, ivgtt, dl ; LV 200 mg/m^2 ivgtt 2h followed by 5 - FU 400 mg/m^2 (bolus) and 5 - FU600 rag/m^2 (22h - coutlnous 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 effica cy and toxicity were evaluated according to RECIST standard. Results: All 43 cases were available for objective response. The overall response rate was 45.0% (CR2, PR7) and DCR was 65.0%in XELOX group of 20cases,RRwas 43.48% (CR3, PR7) ,DCR was 67.86%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 (mTrP)was 7. 1 months in XELOX group and 7. Omonths in FOLFOX4 group. The median survival time (MST) was 13. 8 months in XELOX group and 13.0 months in FOLFOX4 group. The incidence of Peripheral phlebitis and Hypohepatia was significantly lower in XELOX group than in FOLFOX4 group ( P 〈 0. 05) but hand and foot syndrome in XE- LOX group were more obvious than in FOLFOX4 group (P 〈 0. 05) , Incidence of other side effects are no significanceo ( 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.