| Purpose: To compare the antitumor effect and safety of 5FU/LV plus Oxaliplatin and Raltitrexed plus Oxaliplatin in advanced colorectal cancer. Patients and Methods: Forty two patients with measurable disease were randomized into two groups .The experimental group received a 15-minute infusion of Raltitrexed (3mg/m~2) followed by a 2-hour infusion of Oxaliplatin (130mg/m~2) 1 hour later on day 1 every 3 weeks.The control group received a 2-hour infusion of LV (200mg/m~2/d) followed by a 5FU infusion (500mg/m~2/d) daily for 5 consective days every 3 weeks,together with Oxaliplatin (130mg/m~2) as a 2-hour infusion on day 1. Patients were re-evaluated after every two cycles and chemotherapy was continued up to 4 cycles or disease progression. Results: The randomized groups were well balanced demographically. When compared to the control group ,Raltitrexed plus oxaliplatin has lower objective responses rate (38.1% v 45.0%) and disease control rate (81.0% v 85.0%). The difference did not reach significance (P>0.05). With a median 10-month follow-up,median time to progression (6.2 months v 6.7months;T=0.353;P>0.05) and survival (13.4 months v 14.0 months;T=0.186;P>0.05) were comparable between groups.Improvement in quality of life, weight gain and performance status grade down were seen in both groups. Significantly less World Health Organization (WHO) grade 3 and 4 stomatitis (4.7% v 33.3%;P =0.049) and a reduced incidence of leukopenia (9.4% v 33.3% ; P = 0.03) occurred in the...
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