奥沙利铂联合羟基喜树碱与氟尿嘧啶治疗转移性结直肠癌的随机对照临床研究  

Hydroxycamptothecine plus oxaliplatin compared with fluorouracil/leucovorin (LV5FU2) plus oxaliplatin in the treatment of metastatic colorectal cancer:a randomized clinical study

作　　者：宁四海[1] 陈绍俊[1] 黄海欣[1] 李桂生[1] 

机构地区：[1]广西医科大学第四附属医院肿瘤科,广西柳州545005

出　　处：《中国癌症杂志》2009年第4期284-287,共4页China Oncology

摘　　要：背景与目的:化疗可提高转移性结直肠癌患者的生活质量,延长生存期。含氟尿嘧啶的联合方案是转移性结直肠癌的标准治疗方案,而其不良反应是化疗的限制性因素,影响患者的生活质量。因此探索新的方案显得十分必要。本研究观察及比较两种常用化疗方案[羟基喜树碱(HCPT)联合奥沙利铂(OXA)方案(HCPTOX)与氟尿嘧啶(5-FU)/亚叶酸钙(LV)联合OXA方案(FOLFOX4)]治疗转移性结直肠癌的临床疗效及不良反应。方法:47例转移性结直肠癌患者随机分成两组,HCPTOX组与FOLFOX4组。HCPTOX组24例,给予HCPT6mg/m2,静脉滴注,第1～5天;OXA130mg/m2,静脉滴注,第1天;21d为1个周期。FOLFOX4组23例,给予OXA85mg/m2,静脉滴注,第1天;LV200mg/m2,静脉滴注2h滴完后再给予5-FU400mg/m2,静脉推注,后续600mg/m2持续静脉滴注22h,第1、2天;每2周重复,4周为1个周期。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:入组47例均可评价疗效,HCPTOX组有效率为50.0%,中位TTP7.8个月,MST13.1个月,FOLFOX4组有效率47.8%,中位TTP7.9个月,MST13.3个月。两组近期有效率差异无显著性(P>0.05)。不良反应比较,患者Ⅲ/Ⅳ级恶心、呕吐发生率以FOLFOX4组显著(P<0.05)。除腹泻外,其他不良反应发生率以FOLFOX4组稍高,但差异均无显著性(P>0.05)。结论:HCPTOX方案与FOLFOX4方案治疗转移性结直肠癌均疗效确切,不良反应均能耐受。两组近期疗效相似,不良反应以HCPTOX组较易耐受,尤其对一般情况欠佳及老年患者耐受性较好。Background and purpose： It has been proved that chemotherapy could improve the quality of life and prolongation of survival time of the patients with metastatic colorectal cancer. Fluorouracil （5-FU）-based chemotherapy has become a standard regimen for treatment of metastatic colorectal cancer, but the toxicities are considered to be limiting factors and influence the quality of life in the patients with advanced metastatic colorectal cancer.Thus, it is necessary to find a new regimen as a substitute. The objective of this study was to evaluate the efficacy and toxicity of hydroxycamptotheeine plus oxaliplatin regimen （HCPTOX） versus fluorouracil/leucovorin （LV5FU2） plus oxaliplatin regimen （FOLFOX4） in the treatment of metastatic colorectal cancer and tried to find the regimen more tolerable without the deterioration of treatment response. Methods： 47 cases with metastatic colorectal cancer were enrolled into this study, 24 patients and 23 patients were randomly divided into HCPTOX group and FOLFOX4 group respectively. HCPTOX group was treated with hydroxycamptothecine 6 mg/m^2, ivgtt, d 1-d 5; oxaliplatin 130 mg/（m^2·d）, ivgtt, d 1. FOLFOX4 group was treated with oxaliplatin 85 mg/（m^2 .d）, ivgtt, d 1; LV 200 mg/m^2 ivgtt 2 hr followed by 5-Fu 400 mg/m^2 （bolus） and 5-FU 600 mg/m^2（22 hr-coutinous infusion）.HCPTOX 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 47 cases were available for objective response. The overall response rate was 50.0 % （CR 2, PR 10） in HCPTOX group of 24 cases and 47.8%（CR 1,PR 10） in FOLFOX4 group of 23 cases, respectively. There was no significant difference between the two groups （X^2=0.222,P〉0.05）.The median time to progression （mTTP） was 7.8 months in HCPTOX group and 7.9 months in FOLFOX4 group, respectively. The median

关 键 词：羟基喜树碱 奥沙利铂 氟尿嘧啶/亚叶酸钙 转移性结直肠癌 联合化疗 

分 类 号：R735.377[医药卫生—肿瘤] R730.53[医药卫生—临床医学]