Data published in the New England Journal of Medicine show that oral capecitabine(Drug information on capecitabine) (Xeloda) and oxaliplatin(Drug information on oxaliplatin) (Eloxatin) in combination with epirubicin (Ellence) is a comparable alternative to infused fluorouracil(Drug information on fluorouracil) (5-FU) and cisplatin(Drug information on cisplatin) with epirubicin(Drug information on epirubicin) in patients with previously untreated, advanced esophagogastric cancer. In the study, median survival time was longer and 1-year survival was higher among patients taking EOX (epirubicin/oxaliplatin/capecitabine) compared to the standard treatment, ECF (epirubicin/cisplatin/5-FU)."Our research suggests that oral Xeloda and oxaliplatin can provide patients with a valuable option over the standard regimen of infused fluorouracil and cisplatin in combination with epirubicin as a first-line therapy for esophagogastric cancer," stated lead investigator David Cunningham, MD, frcp, head of the Gastrointestinal and Lymphoma Units of the Royal Marsden Hospital National Health Service Foundation Trust of Surrey and London.
About the Study
The phase III REAL 2 study was conducted in 1,002 advanced esophagogastric cancer patients from 61 centers mainly in the United Kingdom. The study aimed to establish the potential use of capecitabine and oxaliplatin in previously untreated patients, and the primary endpoint was noninferiority in overall survival in patients who received capecitabine compared to those who received fluorouracil and for those who took oxaliplatin compared to cisplatin.
Patients were randomized to one of four regimens. Median survival times in the ECF, ECX (epirubicin/cisplatin/capecitabine), EOF (epirubicin/oxaliplatin/5-FU) and EOX groups were 9.9, 9.9, 9.3, and 11.2 months, respectively; 1-year survival rates were 37.7%, 40.8%, 40.4%, and 46.8%, respectively. In a secondary analysis, overall survival was statistically significantly longer with EOX than with ECF, with a hazard ratio of 0.80 in the EOX group (95% confidence interval = 0.66–0.97; P = .02).