In the first-ever phase III trial of oral capecitabine (Xeloda) as first-line treatment for gastric cancer, capecitabine plus cisplatin was found to be at least as effective and safe in achieving progression-free survival as the current standard of care for gastric cancer-intravenous fluorouracil (IV 5-FU) plus cisplatinwith higher overall response rates, according to final data presented at the 42nd Annual American Society of Clinical Oncology (ASCO) Annual Meeting in Atlanta.
"Patients diagnosed with advanced gastric cancer have a poor prognosis, and treatment can be very cumbersome," said Howard Burris, MD, Sarah Cannon Research Institute, Nashville. "With the combination of Xeloda 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."
About the Study
This international, randomized, phase III noninferiority 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/cisplatin vs the current standard treatment, IV 5-FU 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/cisplatin arm lived at least as long without the cancer progressing as those treated with 5-FU/cisplatin (median progression-free survival: 5.6 vs 5 months, hazard ratio [HR] = 0.81, P < .001), and also lived at least as long overall (10.5 vs 9.3 months, HR = 0.85, P = .008), showing strong evidence of noninferiority. The capecitabine/cisplatin overall response rate was superior to standard therapy (41% vs 29%, P = .030). Further, capecitabine/cisplatin reduced the amount of time patients need to spend in the clinic by 80% (1 day vs 5 days every 3 weeks).
Both study arms had acceptable and similar safety profiles, with no unexpected toxicities; capecitabine/cisplatin was as least as well tolerated as 5-FU/cisplatin. The most common grade 3/4 adverse events (greater than or equal to 3%) in both arms included neutropenia, vomiting, stomatitis, diarrhea, and anemia. Hand-foot syndrome was more frequent in the capecitabine/cisplatin arm; stomatitis and vomiting were more frequent in the 5-FU/cisplatin arm. Both arms had similar rates of withdrawal due to adverse events, 60-day all-cause mortality, and treatment-related mortality.