FOLFOX6方案治疗结直肠癌肝转移患者的疗效观察

Efficacy and Toxicity of FOLFOX6 Regimen in Treating Colorectal Cancer Patients with Liver Metastasis

背景与目的:FOLFOX6方案应用于晚期结直肠癌已有一段时间,但尚未见系统评价FOLFOX6方案临床研究的报道,本研究观察FOLFOX6方案治疗结直肠癌肝转移患者的疗效及不良反应,以评价该方案在中国应用的可行性和临床推广价值。方法:91例结直肠癌肝转移患者采用FOLFOX6方案化疗,即草酸铂100mg/m2加入5%葡萄糖溶液250ml中静滴2h,d1;甲酰四氢叶酸(leucovorin,CF)400mg/m2加入5%葡萄糖溶液250ml中静滴2h,d1,接着用氟尿嘧啶(5-fluorouracil,5-FU)400mg/m2静脉推注,继以5-FU2.4g/m2持续静脉滴注46h。应用CT、MRI评价每例患者的不良反应及疗效。用X2检验分析两组间有效率的差异,Kaplan-Meier法计算中位生存时间,log-rank法比较生存差异。结果:全组患者CR4例,PR33例,SD19例,PD35例,有效率40.7%,既往未接受其它治疗(第一组,60例)与既往接受过其它治疗(第二组,31例)的患者有效率差异无显著性(P>0.05);中位生存17个月,第一组中位生存20个月,第二组中位生存12个月;疾病进展时间(timetoprogress,TTP)7个月,第一组TTP为9个月,第二组TTP为6个月。主要不良反应为周围神经炎、消化道反应、骨髓抑制等,多为Ⅰ～Ⅱ级,未见Ⅳ级不良反应发生,在用药休息期间或作相应的治疗后均可恢复。结论:FOLFOX6方案作为结直肠癌肝转移的治疗方案,疗效好,且不良反应较轻,是治疗结直肠癌肝转移较为理想的化疗方案。

BACKGROUND ＆ OBJECTIVE： FOLFOX6 regimen has been used in treating advanced colorectal cancer for a period, but there is no systemic study on FOLFOX6 regimen in treating Chinese colorectal cancer patients with liver metastasis. This study was to evaluate the efficacy of FOLFOX6 regimen on Chinese colorectal cancer patients with liver metastasis, and observe the adverse events. METHODS： Ninety-one colorectal cancer patients with liver metastasis were treated by FOLFOX6 regimen. FOLFOX6 regimen consisted of 2-hour infusion of oxaliplatin （100 mg/m^2） and 2-hour infusion of leucovorin （CF） （400 mg/m^2） on Day Ⅰ, followed by 5-fluorouracil （5-FU） bolus （400 mg/m^2） on Day 1 and 46-hour infusion （2.4 g/m^2）. FOLFOX6 regimen was repeated at 2-week intervals. The clinical efficacy and adverse events were evaluated. RESULTS： The objective response rate for all patients was 40.7%, with 4 cases of complete remission （CR）, 33 partial remission （PR）, 19 stable disease （SD）, and 35 progressive disease （PD）. There was no significant difference in objective response rate between the patients with and without previous treatment （P〉0.05）. The median survival time was 17.0 months for all patients, 20.0 months for the patients without previous treatment, and 12.0 months for the patients with previous treatment. The time to progress （TTP） was 7.0 months for all patients, 9.0 months for the patients without previous treatment, and 6.0 months for the patients with previous treatment. Peripheral neuritis, gastrointestinal reaction, and myelosuppression were major adverse events. All patients with 5-FU-associated adverse events recovered after treatment. CONCLUSION： FOLFOX6 regimen can be used in treating colorectal cancer with liver metastasis for its efficacy and less toxicity.