NANTES, FranceResults of a large phase II European trial validate the antitumor activity of capecitabine(Drug information on capecitabine) (Xeloda) in metastatic breast cancer and present a strong rationale for its use earlier in the disease course, said Pierre Fumoleau, MD, coordinator of medical oncology, Centre Rene Gauducheau, Nantes, France.
The multicenter study included 126 patients with advanced breast cancer, most with multiple metastatic sites and previously treated with anthracyclines and taxanes. They received oral capecitabine 1,250 mg/m² twice daily on days 1 to 14, followed by a 1-week rest, every 3 weeks, for a median of six cycles.
The median time to progression was 4.6 months, and the objective tumor response rate was 29% (32 of 111 evaluable patients), including 5% complete responses and 24% partial responses, Dr. Fumoleau reported at the 38th Annual Meeting of the American Society of Clinical Oncology (abstract 247). So far, the median duration of response is 5 months, median overall survival is estimated to be 15.2 months, and 1-year survival is 60%.
The main toxicity was hand-foot syndrome, which occurred in 21% of patients and, according to Dr. Fumoleau, was quite manageable. About 5% of patients discontinued therapy because of this side effect, but 37% of these patients were managed with dose reductions, he said. Other grade 3-4 toxicities included granulocytopenia (11% grade 3 and 3% grade 4), and diarrhea (8% and 2%, respectively). Grade 3 nausea occurred in 4% and grade 3 vomiting in 3%.
A quality-of-life survey showed an improvement in global health status as well as improvements in the components of physical, role, emotional, and cognitive functioning at cycle 6.
"The favorable efficacy of capecitabine in this context confirms earlier pivotal trials in the United States," Dr. Fumoleau noted.