Xeloda outperforms IV therapy in trials

Roche's orally-active anticancer drug Xeloda (capecitabine) has beenfound to be significantly superior to an intravenous regimen based on 5-fluorouracil and leucovorin in achieving tumor response rates in patients with advanced colorectal cancer. The new drug was also associated with a favorable toxicity profile and was preferred by patients, who could now receive treatment at home.

The results of the study, reported in the Journal of Clinical Oncology (April 15), indicated that Xeloda, given at home in two-week cycles, with a week's rest in between, was associated with a tumor response rate of 24.8%, which compared favorably with the 15.5% rate seen with 5-FU/leucovorin. The latter was given according to the standard Mayo Clinic regimen which requires five-day dose cycles in hospital, repeated if necessary after 23 days. Secondary endpoints, including the time to disease progression and overall survival, were similar between the two treatment groups.

The authors of the study, led by Paulo Hoff of the Albert Einstein Hospital in Sao Paulo, Brazil, also note that Xeloda offers "several clinically meaningful advantages over 5-FU/leucovorin in terms of tolerability." These include a significantly-lower incidence of diarrhea, mouth ulcers, nausea and hair loss, as well as significantly-fewer hospitalizations due to adverse reactions, neutropenia, neutropenic fever and sepsis. The Roche drug was associated with a higher incidence of hand-foot syndrome, a localized skin reaction which was manageable with dose reductions or cessation of therapy.