Important new data highlights Roche's Xeloda (capecitabine), an oral tumor-activated chemotherapy, in combination with Eloxatin (oxaliplatin) for first-line treatment of patients with metastatic colorectal cancer. Data from another study also show promise in the use of Xeloda monotherapy as an option for first-line therapy in esophago-gastric cancer and in combination with other chemotherapy agents.

James Cassidy, Professor of Medical Oncology, Glasgow University, Glasgow, Scotland, presented updated data from ASCO 2002 on an international Phase II study of Xeloda in combination with oxaliplatin (XELOX) as first-line therapy for metastatic colorectal cancer. The data from this 96-patient study show an objective response rate of 55 per cent with an additional 32 per cent of patients having stable disease for greater than three months. In addition, median survival is 19.5 months and median time to progression is currently 7.6 months. Patients enrolled in this study received 130 mg/m2 of oxaliplatin intravenously day 1 of each 21-day treatment cycle and 1,000 mg/m2 of oral Xeloda twice daily days 1-14 with one week rest.

Oxaliplatin, in combination with 5-FU/LV, was approved by the U.S. FDA as second-line therapy for metastatic colorectal cancer on August 9, 2002. Xeloda was approved by the U.S. FDA on April 30, 2001 as first-line treatment for metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred.

"These results are encouraging and demonstrate the potential of Xeloda as a combination agent with oxaliplatin in colorectal cancer," said Peter Kozuch, St. Luke's-Roosevelt Hospital, New York, N.Y. "These results may be good news for physicians as they point to potential new options in the management of colorectal cancer."

Niall Tebbutt, of Royal Marsden Hospital, Sutton, United Kingdom, presented interim analysis from a randomized, multicenter Phase III study comparing Xeloda with 5-FU and oxaliplatin with cisplatin in patients with advanced esophago-gastric cancer. This study is a four-arm study comparing the following regimens: ECF (epirubicin, cisplatin, continuous infusional (CI) 5-FU) versus ECX (epirubicin, cisplatin, Xeloda twice daily without rest for the duration of therapy) and EOF (epirubicin, oxaliplatin, CI 5-FU) versus EOX (epirubicin, oxaliplatin, Xeloda twice daily without rest for the duration of therapy). The interim results of this study has demonstrated an overall response rate of 54 percent for the Xeloda treatment arms versus 28 per cent for the CI 5-FU treatment arms and 34 per cent for the cisplatin treatment arms versus 47.5 per cent for the oxaliplatin treatment arms. Additionally, rates of time to disease progression were 13 per cent in the Xeloda treatment arms versus 33 per cent in the 5-FU treatment arms and 20 per cent in the cisplatin treatment arms versus 25 per cent in the oxaliplatin treatment arms. The safety profile included the incidences of diarrhea, stomatitis and hand-and-foot syndrome at 14 per cent, 3 per cent and 3 per cent for the 5-FU treatment arms and 3 per cent, 0 per cent and 3 per cent respectively for the Xeloda treatment arms. The incidence of grade 3/4 neutropenia ranged from 32 to 42 per cent; however, it was generally brief in duration and the incidence of febrile neutropenia ranged from 2 to 6 per cent. This interim analysis is based on 80 patients, however the study plans to recruit a total of 600 patients. This is the first study comparing Xeloda to continuous infusional 5-FU regimen.