Researchers affiliated with the REAL 2 Trial have concluded that Xeloda (capecitabine) can replace 5-FU (5-fluorouracil) and Eloxatin (oxaliplatin) can replace Platinol® (cisplatin) for the treatment of cancers of the esophagus, esophageal junction or stomach. The details of this randomized phase III study were presented at the June 2006 meeting of the American Society of Clinical Oncology in Atlanta.

Platinol and 5-FU are standard drugs for the treatment of advanced esophageal, esophageal junction and gastric cancers. However, oral Xeloda has been found to be as effective as 5-FU for the treatment of colorectal cancer, and Eloxatin has been found to be superior to Platinol with fewer side effects for the same purpose.

The purpose the current trial was to determine the effectiveness of Xeloda and Eloxatin for the treatment of esophageal and gastric cancers when compared to standard 5-FU- and Platinol-based regimens.

In this study, 1002 patients with advance esophagus, esophageal junction or stomach cancer were randomly allocated to receive treatment with:

• ECF = Ellence® (epirubicin), Platinol and 5-FU     
• EOF = Ellence, Eloxatin, and 5-FU
• ECX = Ellence, Platinol and Xeloda
• EOX = Ellence, Eloxatin and Xeloda

The median follow-up of this study was 17 months. One year survival ranged from 37.7% to 46.8% with no statistically significant difference between regimens. Median overall survival ranged from 9.3 to 11.2 months with no significant differences between regimens. However, the best results were achieved in the group receiving EOX with a one year overall survival of 46.8% and a median overall survival of 11.2 months. Statistical tests confirmed non-inferiority of the three experimental regimens compared to the standard ECF regimen.

Comments: These results are similar to those observed in patients with colorectal cancer suggesting that Xeloda and Eloxatin can replace Platinol and 5-FU for the treatment of advanced esophageal and gastric cancer. There is also agreement that patients prefer Xeloda to 5-FU because of oral administration.

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Reference: Cunningham D, Rao S, Starling N, et al.Randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric (OG) cancer: The REAL 2 Trial. Journal of Clinical Oncology . 2006:24; abstract # LBA4017.