顺铂
医学
化疗
紫杉醇
内科学
胃切除术
癌症
阶段(地层学)
临床终点
新辅助治疗
临床研究阶段
肿瘤科
随机对照试验
胃肠病学
乳腺癌
古生物学
生物
作者
Takaki Yoshikawa,Satoshi Morita,Kazuaki Tanabe,Kazuhiro Nishikawa,Y. Ito,Takanori Matsui,Kazumasa Fujitani,Yutaka Kimura,Junya Fujita,Toru Aoyama,Tsutomu Hayashi,Haruhiko Cho,Akira Tsuburaya,Yumi Miyashita,Junichi Sakamoto
标识
DOI:10.1016/j.ejca.2016.04.012
摘要
BackgroundThe prognosis for stage III gastric cancer is unsatisfactory by D2 gastrectomy and S-1 adjuvant chemotherapy. Both S-1 plus cisplatin (SC) and paclitaxel plus cisplatin (PC) are promising regimens as neoadjuvant chemotherapy; however, the optimal duration remains unclear.Patients and methodsIn this 2×2 randomised phase II trial, stage III gastric cancer patients, those with a prognosis corresponding to stage III, and macroscopically resectable stage IV cases were randomised to two or four courses of S-1 (80 mg/m2 for 21 d with 1 week rest)/cisplatin (60 mg/m2 at day 8) or PC (80 and 25 mg/m2, respectively, on days 1, 8, and 15 with 1 week rest) as neoadjuvant chemotherapy. The primary end-point was the 3-year overall survival (OS).ResultsBetween October 2009 and July 2011, 83 patients received 2 courses of SC (n=21), 4 courses of SC (n=20), 2 courses of PC (n=21) and 4 courses of PC (n=21). The 3-year OS was 60.9% for SC and 64.3% for PC and 64.3% for the two courses and 61.0% for the four courses. Subset analyses demonstrated no subgroup which showed any potential survival benefit by PC in comparison to SC or by four courses as in comparison to two courses.ConclusionsTwo courses of SC as neoadjuvant chemotherapy are recommended as a test arm of a future phase III study for patients with locally advanced gastric cancer.Clinical trial numberUMIN-000002595.
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