OBJECTIVETo evaluate the therapeutic efficacy and adverse reaction of Aidi Injection (ADI) combined with FOLFOX4 regimen for treatment of patients with advanced colorectal cancer, and controlled with those of FOLFOX4 regimen alone.

METHODSOne hundred and seventeen patients were randomized into two groups. All received FOLFOX4 regimen, i.e. Oxaliplatin 85 mg/m2 intravenous dripping in 2 h on day 1, leucovorin CF 200 mg/m2 intravenous dripping and 5-FU 400 mg/m2 intravenous injection followed with 600 mg/m2 continuous infusion by micro-pump in 22 h on day 1 and 2, 14 days as one cycle. Besides, to the treatment group (65 patients), ADI was administered additionally by adding 60 mL ADI in 250 mL 5% glucose for intravenous dripping every day for 10 successive days, while to the control group (52 patients), no additional medication was given.

RESULTSThe response rate in the treatment group was 44.62%, and in the control group 30.77% (P = 0.126), the KPS score improving rate in the two groups was 66.15% and 40.38% respectively (P = 0.005), the 1-year survival rate was 53.85% and 40.38% respectively (P = 0.148), and the adverse reaction presented in the treatment group was greatly less than that in the control group (P < 0.05).

CONCLUSIONADI in combining with FOLFOX4 regimen can enhance the efficacy, reduce the adverse reaction of chemotherapy in treating advanced colorectal cancer, and could also improve the quality of life and prolong the survival time of patients.