BACKGROUND: This phase III trial compared the efficacy and safety of @entity136 plus @entity416 (GemCap) versus single-agent @entity136 ( @entity14113 ) in advanced @entity788 as first-line chemotherapy. METHODS: A total of 214 advanced @entity788 @entity1 were enrolled from 16 hospitals in South Korea between 2007 and 2011. @entity1 were randomly assigned to receive GemCap (oral @entity416 1660mg/m plus @entity14113 1000mg/m by 30-minute intravenous infusion weekly for 3 weeks followed by a 1-week break every 4 weeks) or @entity14113 (by 30-minute intravenous infusion weekly for 3 weeks every 4 weeks). RESULTS: Median @entity1349 ( @entity1349 ) time, the primary end point, was 10.3 and 7.5 months in the GemCap and @entity14113 arms, respectively (P=0.06). Progression-free survival was 6.2 and 5.3 months in the GemCap and @entity14113 arms, respectively (P=0.08). GemCap significantly improved overall response rate compared with @entity14113 alone (43.7% vs 17.6%; P=0.001). Overall frequency of grade 3 or 4 @entity137 was similar in each group. @entity1398 was the most frequent grade 3 or 4 @entity137 in both groups. CONCLUSION: GemCap failed to improve @entity1349 at a statistically significant level compared to @entity14113 treatment. This study showed a trend toward improved @entity1349 compared to @entity14113 alone. GemCap and @entity14113 both exhibited similar safety profiles.

A randomized, multicenter, phase III study of @entity136 combined with @entity416 versus XXXX alone as first-line chemotherapy for advanced @entity788 in South Korea.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity788 :: ('MESH:D010190', 'Disease') :: ['pancreatic cancer'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity416 :: ('MESH:C110904', 'Chemical') :: ['capecitabine'] @entity14113 :: ('C056507', 'Chemical') :: ['Gem'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['Neutropenia'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity136 :: (MESH:C056507,Chemical) :: ['gemcitabine']
