Abstract
e15267 Background: Based on the results of the GEST study, S-1 was confirmed to be non-inferior to gemcitabine. However, the recommended standard regimen frequently causes adverse events(AEs). On the other hand, a multi-center prospective phase II study showed that the alternate-day administration of S-1 reduced AEs and was tolerable for unresectable advanced pancreatic ductal adenocarcinoma (PDAC) patients. Accordingly, we conducted a multi-center randomized phase II study to investigate the non-inferiority of S-1 using alternate-day administration, compared with the standard regimen for unresectable PDAC. Herein, we report the interim safety analysis results of this study. Methods: Patients who met the study criteria (histologically-confirmed PDAC, age > 20, ECOG Performance Status of 0 or 1, no prior chemotherapy or radiotherapy, and adequate organ functions) were randomly assigned at a ratio of 1:2 to standard daily S-1 administration (Arm A: 4 weeks of administration followed by 2 weeks of rest) or a...
Published Version
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