"Patients diagnosed with advanced gastric cancer have a poor prognosis and treatment can be very cumbersome," said Howard Burris, MD, Sarah Cannon Research Institute. "With the combination of Xeloda (capecitabine) and cisplatin, we're seeing the promise of a treatment option that is as effective as standard therapy, well-tolerated and has the added benefit of reducing the amount of time needed for treatment at a clinic or hospital, which may help some patients continue to spend valuable time with family and friends."

The international, randomized, Phase III non-inferiority study, conducted by Professor Y. K. Kang of the Asan Medical Center, Seoul, South Korea, in patients with advanced gastric cancer compared progression-free survival with capecitabine and cisplatin versus the current standard treatment, intravenous 5-fluorouracil plus cisplatin.

The study included 316 patients from 46 centers in 13 countries who were previously untreated and had advanced or metastatic gastric cancer. Patients in the capecitabine arm had at least as long a progression-free survival as those treated with 5-fluorouracil (median 5.6 versus 5 months) and also lived at least as long overall (10.5 versus 9.3 months).

The capecitabine overall response rate was superior to standard therapy (41 percent versus 29 percent). Further, capecitabine reduced the amount of time patients needed to spend in clinic by 80 percent (one day versus five days every three weeks).

Both study arms had acceptable and similar safety profiles, with no unexpected toxicities. The most common grade 3-4 adverse events in both arms included neutropenia, vomiting, stomatitis, diarrhea and anemia. Hand-foot syndrome was more frequent in the capecitabine arm; stomatitis and vomiting were more frequent in the 5-FU arm. Both arms had similar rates of withdrawal due to adverse events, 60-day all-cause mortality, and treatment-related mortality.

Inactive in pill form, capecitabine is enzymatically activated within the body to become 5-FU. Because many cancers have higher levels of the necessary enzyme than does normal tissue, more active chemotherapeutic agent is delivered to the tumor than to other tissue.

A clinically important drug interaction between capecitabine and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Age greater than 60 years and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.