OFL方案时辰化疗与常规FOLFOX6方案一线治疗晚期结直肠癌效果比较

目的 比较奥沙利铂（OXA）联合氟尿嘧啶（5-FU）及亚叶酸钙（LV）组成的OFL方案时辰化疗与常规FOLFOX6方案一线治疗晚期结直肠癌（ACC）的效果、安全性和总生存.方法 109例晚期结直肠癌初治患者随机接受OFL方案时辰化疗和FOLFOX方案常规化疗.时辰组55例采用Melodie编程输液泵,OXA 25 mg/m2每天,d1～d4,10：00～22：00持续静滴,高峰为16：00,5-FU 600 mg/m2每天,d1～d4,22：00～次日10：00持续静滴,高峰为凌晨4：00,LV 200 mg,/m2每天,d1～d4,用法同5-FU.常规组54例白天给药,OXA 100 mg/m2静滴,d1,LV 400 mg/m2静滴d1,5-FU 400 mg/m2静推d1,随即5-FU 2400 mg/m2持续滴注46 h.上述方案每两周给药,至少使用3周期后评价疗效.主要研究终点为疗效和毒性,次要研究终点为无进展生存期（PFS）和总生存期（OS）.结果 时辰组和常规组的总有效率（RR）和疾病控制率（DCR）分别为54.5％ （30/55）、48.1％（26/54）和72.7％ （40/55）、68.5％（37/54）;两组比较差异均无统计学意义（P＞0.05）.时辰组和常规组的PFS分别为6.3个月和6.0个月,差异无统计学意义（P=0.476）,OS分别为17.8个月和15.9个月,差异有统计学意义（P=0.003）.两方案常见的毒副反应为恶心呕吐、中性粒细胞减少、脱发和疲乏,毒副反应在时辰组中的发生率低于常规组（P＜0.05）.结论 OFL方案时辰化疗一线治疗晚期结直肠癌患者毒副反应发生率明显低于常规FOLFOX6方案,患者耐受性较好,有生存获益的趋势,值得进一步开展前瞻性研究.

Effect comparison between OFL regimen chronochemotherapy and routine FOLFOX6 regimen in the first-line treatment of advanced colorectal cancer

Objective To compare the efficacy,safety and overall survival of OFL regimen chronochemotherapy consisted of oxaliplatin （OXA） combined with fluorouracil （5-FU） and calcium folinate （LV） with FOLFOX6 regimen routine chemotherapy in the first-line treatment of patients with advanced colorectal cancer （ACC）.Methods 109 cases of untreated advanced colorectal cancer patients were randomized received OFL regimen chronochemotherapy and FOLFOX6 regimen routine chemotherapy respectively.55 patients in the chronochemotherapy group using Melodie programming pump,OXA 25 mg/m2 per day,d1-d4,from 10：00 to 22：00 at peak time 16：00; 5-FU 600 mg/m2 per day,d1-d4,from 22：00 to 10：00 at peak time 4：00; LV 200 mg/m2 per day,d1-d4,usage was the same like 5-FU.There were 54 patients in the routine chemotherapy group,the drugs were given conventionally as OXA 100 mg/m2 iv,d1,LV 400 mg/m2,d1 iv,5-FU 400 mg/m2 ivgtt,d1,followed by 5-FU 2400 mg/m2,continued iv by drip for 46 h.Each cycle was repeated every 14 days and patients must receive at least 3 cycles for evaluation.The primary end point was efficacy and toxicity and the secondary end point was progression-free survival （PFS） and overall survival （OS）.Results The response rate （RR） and disease control rate （DCR） in chronochemotherapy group and routine chemotherapy group were 54.5％ （30/55）,48.1％（26/54） and 72.7％ （40/55）,68.5％ （37/54） respectively and there were no statistics differences （P ＞ 0.05）.The PFS in chronochemotherapy group and routine chemotherapy group were 6.3 months and 6.0 months respectively,which had no statistics differences （P =0.476）.The OS were 17.8 months and 15.9 months respectively which had statistics differences （P =0.003）.The frequent side-effects in the two groups were nausea,vomiting,neutropenia,alopecia and fatigue.The toxicities in chronochemotherapy group was lower than that in routine chemotherapy group （P＜ 0.05）.Conclusion The OFL regimen chronochemotherapy have obvious lower toxicities and better tolerance than FOLFOX6 regimen routine chemotherapy in the first-line treatment of patients with advanced colorectal cancer.The chronochemotherapy tend to obtain benefits on overall survival and worth further perspective study.