According to the results of a Phase III clinical trial published in the New England Journal of Medicine, it may be possible to replace 5-FU (5-fluorouracil) with Xeloda® (capecitabine) and to replace cisplatin (Platinol®) with Eloxatin® (oxaliplatin) in the treatment of advanced esophageal and gastric cancers.
For patients with advanced cancer of the esophagus, stomach, or esophagogastric junction (area where the esophagus joins the stomach), chemotherapy has been shown to improve survival. Chemotherapy drugs that are commonly used for these cancers include cisplatin and 5-FU.
Xeloda is an oral chemotherapy drug that offers a more convenient approach to treatment than 5-FU. Xeloda is currently approved for certain patients with breast and colorectal cancers. Eloxatin is also approved for colorectal cancer, and appears to offer advantages over cisplatin in this setting.
To explore the role of Xeloda and Eloxatin in advanced esophageal and gastric cancers, researchers conducted a Phase III clinical trial. The study enrolled 1,002 patients with locally advanced (inoperable) or metastatic cancer of the esophagus, esophagogastric junction, or stomach.
Patients were assigned to one of four treatment groups:
- ECF (Ellence® (epirubicin), cisplatin, and 5-FU)
- ECX (Ellence, cisplatin, and Xeloda)
- EOF (Ellence, Eloxatin, and 5-FU)
- EOX (Ellence, Eloxatin, and Xeloda)
One-year survival was 37.7% for ECF, 40.8% for ECX, 40.4% for EOF, and 46.8% for EOX.
Progression-free survival and response rates did not differ significantly across treatment groups. Overall survival was longer with EOX than with ECF.
Toxic effects of Xeloda and 5-FU were similar. Compared to cisplatin, Eloxatin was less likely to cause grade 3 or 4 neutropenia, hair loss, kidney problems, and blood clots, but slightly more likely to cause grade 3 or 4 diarrhea and neuropathy.
The researchers conclude that Xeloda is as effective as 5-FU and that Eloxatin is as effective as cisplatin. Xeloda and Eloxatin may be able to replace 5-FU and cisplatin in the treatment of advanced esophageal and gastric cancers.
Reference: Cunningham D, Starling N, Rao S et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. New England Journal of Medicine. 2008;358:36-46.