Randomized, Control Study Of Calcium Levofolinate Or Calcium Folinate Plus 5-fluorouracil And Oxaliplatin In Metastatic Colorectal Cancer

Objective: To evaluate the efficacy and safety of Calcium levofolinate (L-CF) plus 5-fluorouracil(5-Fu) and oxaliplatin(L-OHP) by comparing with Calcium folinate (CF) plus 5-Fu and L-OHP for patients with metastatic colorectal cancer. Methods: 52 patients with metastatic colorectal cancer were randomly assigned into two groups with double blind method, and received oxaliplatin 200mg by iv infusion on day 1, L-CF 100mg/m2 (or CF 200mg/m2) followed by 5-Fu 300mg/dm2 from day 1 to day 5, 3 weeks a cycle. Radiology such as CT scan was used to evaluate the efficacy of the regimen by the end of the second cycle, then the efficacy and toxicities would be assessed. Results: 52 patients equally entered CF arm and L-CF arm. 22 patients completed the treatment required by this study in CF arm and 24 patients in L-CF arm. CR was observed in no patients. The response rate (CR + PR) was 18.2 % (n=22), with 4 PR,12 SD and 6 PD, and 29.2% in L-CF arm (n=24), with 7PR, 13 SD and 4 PD, without any significant difference (P>0.05). The stratification results based on all the enrolled patients were as follows: The response rate was 26.9% (7/26) for patients with colon cancer, and 20.0% (4/20) for patients with rectal cancer, without any significant difference; 8 PR was observed in 30 cases of liver metastasis...