• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国卫生研究院文献>British Journal of Cancer >Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF
【2h】

Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF

机译：在接受ECF的晚期食管胃癌患者中比较卡培他滨与氟尿嘧啶和奥沙利铂与顺铂的两项多中心随机III期研究的两项方案计划的中期分析报告

代理获取
本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

The purpose of the study was to establish the optimal dose of capecitabine (X) to be used within a multicentre, randomised study evaluating the potential roles of oxaliplatin (O) and X in chemonaive patients (pts) with advanced oesophagogastric cancer. Two by two design was used, and pts were randomised to one of four regimens and stratified for extent of disease, performance status (PS) and centre. The treatment regimens are epirubicin, cisplatin, 5-fluorouracil (ECF), EOF, ECX or EOX. Doses: E 50 mg m−2, C 60 mg m−2 and O 130 mg m−2 i.v. 3 weekly; F 200 mg m−2 day−1 i.v. and X 500 mg m−2 b.i.d.−1 (escalated to 625 mg m−2 b.i.d.−1 after results of first interim analysis) p.o., continuously. First interim analysis was performed when 80 pts had been randomised. Dose-limiting fluoropyrimidine toxicities were stomatitis, palmar plantar erythema (PPE) and diarrhoea; 5.1% of X-treated pts experienced grade 3/4 toxicity. Protocol planned dose escalation of X to 625 mg m−2 b.i.d.−1 was instituted and a second interim analysis has been performed; results are presented in this paper. A total of 204 pts were randomised at the time of the protocol planned 2nd interim analysis. Grade 3/4 fluoropyrimidine-related toxicity was seen in 13.7% pts receiving F, 8.4% pts receiving X 500 mg m−2 b.i.d.−1 and 14.7% pts receiving X 625 mg m−2 b.i.d.−1. Combined complete and partial response rates were ECF 31% (95% CI 18.7–46.3), EOF 39% (95% CI 25.9–53.1), ECX 35% (95% CI 21.4–50.3), EOX 48% (95% CI 33.3–62.8). Grade 3/4 fluoropyrimidine toxicity affected 14.7% of pts treated with X 625 mg m−2 b.i.d.−1, which is similar to that observed with F, confirming this to be the optimal dose. The replacement of C by O and F by X does not appear to impair efficacy. The trial continues to total accrual of 1000 pts.
机译：该研究的目的是确定在多中心，随机研究中使用的卡培他滨（X）的最佳剂量，以评估奥沙利铂（O）和X在晚期食管胃癌放化疗患者（pts）中的潜在作用。使用二乘二设计，将pts随机分配至四种治疗方案之一，并根据疾病程度，表现状态（PS）和中心进行分层。治疗方案是表柔比星，顺铂，5-氟尿嘧啶（ECF），EOF，ECX或EOX。剂量：E 50 mg m -2 ，C 60 mg m -2 和O 130 mg m -2 i.v.每周3次； F 200 mg m −2 day −1 i.v.和X 500 mg m −2 bid −1 （升级为625 mg m −2 bid -1 之后第一次中期分析的结果）连续。随机分配80分后进行第一次中期分析。限制剂量的氟嘧啶的毒性为口腔炎，掌plant红斑（PPE）和腹泻。 X射线治疗的患者中有5.1％经历了3/4级毒性。制定了协议计划将剂量增加X至625 mg m -2 b.i.d. -1 ，并进行了第二次中期分析；结果在本文中提出。在方案计划的第二次中期分析时，总共随机抽取了204分。接受F的13.7％点，接受X 500μmgm -2 bid -1 的8.4％点和接受X的14.7％的点见到3/4级氟嘧啶相关的毒性625 mg m −2 bid -1 。完全和部分缓解率分别为ECF 31％（95％CI 18.7-46.3），EOF 39％（95％CI 25.9-53.1），ECX 35％（95％CI 21.4-50.3），EOX 48％（95％CI） 33.3–62.8）。 3/4级氟嘧啶毒性影响了X 625 -2 bid -1 处理的pts的14.7％，与F观察到的相似，证实是最佳剂量。用O替换C并用X替换F似乎没有削弱功效。该审判继续累计了1000分。

著录项

相似文献

  • 外文文献
  • 中文文献
代理获取

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号