25862350
OBJECTIVE	Capecitabine and S-1 are orally administered fluorinated pyrimidines with high-level activity against metastatic breast cancer ( MBC ) .
OBJECTIVE	This randomized , multicenter , phase II study compared the activities and safeties of the oral fluoropyrimidines , capecitabine and S-1 , in breast cancer patients .
METHODS	Patients with MBC were randomly assigned to receive capecitabine 825g/m ( 2 ) twice daily on days 1-21 every 4weeks or S-1 40-60mg twice daily , according to body surface area , on days 1-28 every 6weeks .
METHODS	The primary endpoint was progression-free survival ( PFS ) .
RESULTS	A total of 142 patients were enrolled and randomized to either capecitabine ( N = 73 ) or S-1 ( N = 69 ) .
RESULTS	Median PFS ( progression-free survival ) was 1.2 years for capecitabine and 1.3 years for S-1 , with a hazard ratio ( S-1 / capecitabine ) of 0.85 ( 95 % confidence interval [ CI ] 0.52-1 .38 ) ( P = 0.48 by log-rank ) .
RESULTS	The confirmed objective response rates were 24.0 % for capecitabine and 23.1 % for S-1 ( P = 0.938 ) .
RESULTS	The most common treatment-related adverse events were grade 1-2 in intensity .
RESULTS	Thrombocytopenia ( S-1 : 9.2 % , capecitabine : 1.4 % ; P = 0.040 ) and nausea ( S-1 : 26.2 % , capecitabine : 14.1 % ; P = 0.079 ) were more frequent in the S-1 group , while hand-foot syndrome occurred more often in the capecitabine group ( S-1 : 10.8 % , capecitabine : 25.4 % ; P = 0.029 ) .
CONCLUSIONS	The results of the current study demonstrate that both S-1 and capecitabine are effective and well-tolerated treatments in patients with MBC , while their adverse events were different .
CONCLUSIONS	They are both convenient , orally administered drugs , making them attractive agents for use in outpatient treatment .

