Swiss drugmaker Roche has reported that the first-ever Phase III study investigating Xeloda (capecitabine) as a first-line treatment in advanced stomach cancer has successfully met its primary endpoint. The data show that Xeloda, added to another chemotherapy called cisplatin, is as effective as the current standard treatment (intravenous 5-fluorouracil plus cisplatin) in terms of time to disease progression.
The study, currently underway, is a randomized, open-label trial of the effect of first-line chemotherapy with Xeloda plus cisplatin versus intravenous 5-fluorouracil plus cisplatin on time to disease progression in patients with advanced or metastatic gastric cancer. The secondary endpoints included overall response rate, overall survival, duration of response, time to response and the safety results between the treatment arms.
"These new data are encouraging. For many patients the prognosis has been poor, despite recent advances in managing this common, yet often fatal, disease," said Ed Holdener, head of global development at Roche. "Compared to the current standard, where patients spend five days every three weeks in hospital receiving treatment, Xeloda has the additional benefit of reducing that amount of time to only one day, which helps patients to live as normal life as possible."