ABSTRACT
Objective To compare the effectiveness and safety of raltitrexed and fluorouracil(FU)/leucovorin (LV) combined with oxaliplatin for advanced colorectal cancer. Methods Fifty patients with advanced colorectal cancer diagnosed by histopathology or cytology were randomly divided into two groups with 25 cases each by envelope, but 1 case lost. Patients in experimental group were treated with raltitrexed (3 mg/m2, ≥ 15 min intravenously) combined with oxaliplatin (130 mg/m2 on day 1 ), patients in control group were treated with FU/LV combined with oxaliplatin:LV 100 mg/m2 infusion (over 2 h, from day 1 to day 3 ) followed by FU (400 mg/m2 infusion in 2 h and 600 mg/m2 continuous infusion from day 1 to day 3 ),combined with oxaliplatin ( 130 mg/m2 on day 1 ), 3 weeks were as one cycle. Patients received 6 or less cycles until disease progressed or toxicity could not be tolerated. Results Effective rate was 37.50%(9/24)and 33.33%(8/24) in experimental group and control group respectively (P＞ 0.05). Disease control rate in experimental group was 83.33% (20/24) while in control group was 70.83% ( 17/24 ) (P ＞ 0.05 ). The median time of progression-free survival (PFS) in experimental group and control group was 11.0 months and 9.0 months respectively (95%CI 8.643-11.357,P =0.015). Main adverse effects were anorexia, vomiting, neutropenia, thrombopenia, anemia, neurotoxicity, fatigue, aminotransferase abnormality, and so on. There was no statistic difference between two groups in side effects(P ＞ 0.05). Conclusions Raltitrexed combined with oxaliplatin is an effective regimen for the advanced colorectal cancer. Compared with traditional FU-based regimen, it is more convenient. Patients will have less venous exposure time and hospital days.Effective rate and mean survival time are superior or not inferior in raltitrexed treatment to that of FU-based regimen. Raltitrexed combined with oxaliplatin is worthy to be recommended in treating colorectal cancer.