BARCELONA, Spain—A large European, multicenter phase II trial of XELOX—capecitabine (Xeloda) and oxaliplatin(Drug information on oxaliplatin) (Eloxatin, investigational in the United States)—as first-line therapy for patients with metastatic colorectal cancer produced an objective response in 55% of patients.
Josep Tabernero, MD, Oncologia Medica, Vall d’Hebron Hospital, Barcelona, Spain, presented the results at the 38th Annual Meeting of the American Society of Clinical Oncology (abstract 531).
"The most important finding is that XELOX is a highly effective regimen with a good safety profile," Dr. Tabernero said. "And it is very convenient for the patient."
The XELOX regimen is a logical drug combination, said Christopher Twelves, MD, Cancer Research UK, Glasgow, Scotland. Dr. Twelves spoke at an industry-sponsored symposium held in conjunction with the Orlando ASCO meeting.
"These two molecules have clearly different modes of action, and we know from past experience that fluorouracil(Drug information on fluorouracil) (5-FU)/leucovorin combined with oxaliplatin is a highly active regimen," Dr. Twelves said. "Xeloda is at least as effective as 5-FU and has the advantage of being taken orally. There is no overlap in major toxicities with oxaliplatin and Xeloda. The major toxicity with oxaliplatin is sensory neuropathy, which isn’t a feature of Xeloda. We also have preclinical data suggesting genuine synergy between fluoropyrimidines and oxaliplatin."
Study Protocol
The study involved 96 patients with metastatic colorectal cancer who were given a 2-hour intravenous infusion of oxaliplatin 130 mg/m² on day 1 and oral capecitabine(Drug information on capecitabine) 1,000 mg/m² bid on days 1 through 14, followed by a 7-day rest. Treatment continued for 11 cycles in patients with stable disease or tumor response, or until disease progression.
