biostudies-literatureUnknown79(1)He MM<h4>Background</h4>The first one-arm phase II trial aimed to evaluate and predict efficacy and safety of S-1 plus oral leucovorin (S-1/LV) as first-line chemotherapy for patients with advanced gastric cancer (AGC), using S-1 pharmacogenetic pathway approach.<h4>Patients and methods</h4>A total of 39 patients orally took S-1 at conventional dose and LV simultaneously at a dose of 25 mg twice daily for a week, within a 2-week cycle. The primary endpoint was overall response rate (ORR), while the secondary endpoints were progression-free survival (PFS), time to failure (TTF), overall survival (OS), disease control rate (DCR), and adverse events (AEs). Peripheral blood was sampled prospectively for baseline expression of dihydropyrimidine dehydrogenase (DPD), orotate phosphoribosyltransferase Cancer chemotherapy and pharmacology69-79https://www.ebi.ac.uk/biostudies/studies/S-EPMC5225176biostudies-literaturePhase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway.PMC5225176Chen DLHao YTQiu MZHe MMHe YYWang FZeng ZLJin YRen CWang DSLi YHYuan SQGuo PXu RHWang ZQZhang DSWang ZXZeng YXWang FHLuo HYfalsePhase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway.<h4>Background</h4>The first one-arm phase II trial aimed to evaluate and predict efficacy and safety of S-1 plus oral leucovorin (S-1/LV) as first-line chemotherapy for patients with advanced gastric cancer (AGC), using S-1 pharmacogenetic pathway approach.<h4>Patients and methods</h4>A total of 39 patients orally took S-1 at conventional dose and LV simultaneously at a dose of 25 mg twice daily for a week, within a 2-week cycle. The primary endpoint was overall response rate (ORR), while the secondary endpoints were progression-free survival (PFS), time to failure (TTF), overall survival (OS), disease control rate (DCR), and adverse events (AEs). Peripheral blood was sampled prospectively for baseline expression of dihydropyrimidine dehydrogenase (DPD), orotate phosphoribosyltransferase 2017-01-01T00:00:00Z2017 Jan2026-05-05T18:32:41.38Z2025-05-29T20:28:06.541ZS-EPMC52251762791388110.1007/s00280-016-3209-1