Comparison of two different S-1 plus @entity900 dosing schedules as first-line chemotherapy for metastatic and/or recurrent XXXX : a multicenter, randomized phase III trial (SOS).

@entity1 @entity417 @entity900 @entity1398 @entity65542 @entity28549 @entity420 @entity356
BACKGROUND: Five-weekly S-1 plus @entity900 ( @entity65542 ) is one of the standard first-line regimens for advanced @entity356 ( @entity356 ), proven in a Japanese phase III study. To enhance the dose intensity of @entity900 , 3-weekly S-1 plus @entity900 ( @entity28549 ) was developed. @entity1 AND METHODS: This multicenter, randomized, open-label, phase III study evaluated whether @entity28549 (S-1 80 mg/m(2)/day on days 1-14 and @entity900 60 mg/m(2) on day 1) was noninferior/superior to @entity65542 (S-1 80-120 mg/day on days 1-21 and @entity900 60 mg/m(2) on day 1 or 8) in terms of progression-free survival (PFS). Chemotherapy-naive @entity1 with metastatic, recurrent gastric or gastroesophageal junction @entity420 were randomized 1 : 1 to receive either @entity28549 or @entity65542 . The trial is registered at ClinicalTrials.gov (NCT00915382). RESULTS: Between February 2009 and January 2012, 625 @entity1 were randomized at 42 sites in Korea and Japan. With a median follow-up duration of 32.4 months (range, 13.3-48.6 months) in surviving @entity1 , @entity28549 was not only noninferior but also superior to @entity65542 in terms of PFS [median 5.5 versus 4.9 months; hazard ratio (HR) = 0.82; 95% confidence interval (CI) 0.68-0.99; P = 0.0418 for superiority). There was no difference in overall survival (OS) between the groups (median 14.1 versus 13.9 months; HR = 0.99; 95% CI 0.81-1.21; P = 0.9068). In @entity1 with measurable disease, the response rates were 60% in the @entity28549 arm and 50% in the @entity65542 arm (P = 0.065). Both regimens were generally well tolerated, but grade 3 or higher @entity417 (19% versus 9%) and @entity1398 (39% versus 9%) were more frequent in @entity28549 . CONCLUSIONS: @entity28549 is superior to @entity65542 in terms of PFS. However, since the improvement in PFS was only slight and there was no difference in OS, both @entity28549 and @entity65542 can be recommended as first-line treatments for @entity1 with advanced @entity356 .
