naa a22 4500 510763936 CHVBK 20180411083149.0 cr unu---uuuuu 180411e20131001xx s 000 0 eng 10.1007/s12094-013-1012-6 doi (NATIONALLICENCE)springer-10.1007/s12094-013-1012-6 Randomized phase II study comparing paclitaxel with S-1 vs. S-1 as first-line treatment in patients with advanced gastric cancer [Elektronische Daten] [X. Wang, M. Wang, L. Zhou, X. Lu, J. Yang, H. Yu] Purpose: This randomized phase II study was conducted to compare the efficacy and safety of paclitaxel with S-1 (PS) vs. S-1 in patients with advanced gastric cancer (AGC). Methods: Eighty-two (82) patients were 1:1 randomly assigned to oral S-1 (daily for 2weeks, every 4weeks' cycle) or S-1 (daily for 2weeks, every 4weeks' cycle) plus paclitaxel (on day 1, 8 and 15 of a 4weeks' cycle). S-1 was orally administered with a fixed quantity according to body surface area (BSA), while paclitaxel was given 60mg/m2 i.v. daily through an implanted catheter. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), overall responsible rates and safety. Results: The median OS with PS versus S-1 monotherapy was 14.0 versus 11.0months (P=0.02), survival at 12months was 61.0% in the PS group and 46.3% in the S-1 group. Median PFS was also significantly longer in the PS group (6.0months) than in the S-1 group (4.0months). The overall response rate was determined in 82 evaluable patients, and was significantly higher (P=0.04) with PS (19 patients, 46.3%) than with S-1 monotherapy (10 patients, 24.4%). PS was well tolerated with no treatment-related deaths, all were grade 3-4 gastrointestinal toxicities, including anorexia, nausea, and diarrhea developed in less than 10% of the patients. Conclusions: Combination chemotherapy of paclitaxel with S-1 is well tolerated and active in AGC patients. Further investigation with comparative trials is needed for confirmation. Federación de Sociedades Españolas de Oncología (FESEO), 2013 Advanced gastric cancer nationallicence Paclitaxel nationallicence S-1 nationallicence Efficacy nationallicence Safety nationallicence Wang X. Department of Gastroenterology, Renmin Hospital of Wuhan University, 430060, Wuhan, People's Republic of China aut Wang M. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut Zhou L. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut Lu X. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut Yang J. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut Yu H. Department of Gastroenterology, Renmin Hospital of Wuhan University, 430060, Wuhan, People's Republic of China aut Clinical and Translational Oncology Springer Milan 15/10(2013-10-01), 836-842 1699-048X 15:10<836 2013 15 12094 https://doi.org/10.1007/s12094-013-1012-6 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s12094-013-1012-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Wang X. Department of Gastroenterology, Renmin Hospital of Wuhan University, 430060, Wuhan, People's Republic of China aut NATIONALLICENCE 700 1- Wang M. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut NATIONALLICENCE 700 1- Zhou L. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut NATIONALLICENCE 700 1- Lu X. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut NATIONALLICENCE 700 1- Yang J. Department of Gastroenterology, Wuchang Hospital of Wuhan City, Wuhan, People's Republic of China aut NATIONALLICENCE 700 1- Yu H. Department of Gastroenterology, Renmin Hospital of Wuhan University, 430060, Wuhan, People's Republic of China aut NATIONALLICENCE 773 0- Clinical and Translational Oncology Springer Milan 15/10(2013-10-01), 836-842 1699-048X 15:10<836 2013 15 12094 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer