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/m2per day, d1-d4, from 10∶00 to 22∶00 at peak time 16∶00; 5-FU 600 mg/m2per day, d1-d4, from 22∶00 to 10∶00 at peak time 4∶00; LV 200 mg/m2per 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/m2iv,d1, LV 400 mg/m2, d1iv, 5-FU 400 mg/m2ivgtt, 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 3cycles 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 FOLFOX6regimen 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.