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临床试验/NCT01679054
NCT01679054已完成不适用

Cost-minimization Analysis of Xeloda® vs 5-fluorouracil-based Treatment for Gastric Cancer Patients in Hong Kong

Vivian Wing Yan Lee1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Expected and Unexpected Provider Costs

研究概览

简要总结

This is a retrospective cost-minimization analysis study to compare the costs of treatment with EOF vs EOX regimens in patients with gastric cancer (GC) in Hong Kong. Patient baseline characteristics and cost data will be extracted from records and compared.

详细描述

Background

The oral chemotherapy agent Xeloda® was recently extended by the Hong Kong Hospital Authority as subsidized therapy for the treatment of colorectal cancer1. Xeloda®-based chemotherapy regimen has shown to be more cost-effective than 5-fluorouracil (5-FU) considering they had equivalent clinical efficacy in colorectal cancer treatment2,3. The total cost for 5-FU-based regimen was higher for the healthcare provider and society as a whole. Gastric cancer ranks fourth in cancer-related cause of death in the Hong Kong population4. 5-FU has known antitumor activity and has been used successfully in advanced gastric cancer (aGC) with cisplatin (FP), as well as with oxaliplatin ± epirubicin (FOLFOX4, EOF). When substituted with Xeloda®, the XP and EOX regimens have demonstrated to be noninferior in terms of progression-free survival when compared with FP and EOF, respectively5,6. In an economics evaluation done by the manufacturer for NICE submission on the use of Xeloda® for treatment of aGC, the use of XP regimen allowed a cost reduction while eliminating possible complication related to intravenous therapy7. Moreover, FOLFOX4, one of the common 5-FU-based regimens used locally, has demonstrated to produce a median overall survival of 10 months in advanced/metastatic gastric cancer patients8. An effect similar to that of EOX. Currently, there is no local data suggesting similar economic impact with Xeloda®-based regimen for gastric cancer when compared with 5-FU-based regimens. It is worthwhile to see if Xeloda®-based therapy for gastric cancer is a cost-effective alternative.

Study Objective

To compare retrospective costs of treatment with Xeloda®-based and 5-FU-based regiments in patients with advanced gastric cancer in Hong Kong.

Methods

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were diagnosed with gastric cancer and completed either EOX or EOF chemotherapy treatment

排除标准

  • Patients less than 18 years of age
  • Patient who did not meet inclusion criteria

结局指标

主要结局

Expected and Unexpected Provider Costs

时间窗: At the completion of respective chemotherapy regimen, up to 6 months

Expected and unexpected provider costs (chemotherapy, hospital stay, lab tests, clinic visits, AE management, other drug costs). The costs for healthcare resources usage, including hospital visits and laboratory investigations, were valued according to the Hong Kong Government Gazette 2003, which is the most updated version of official source for costs of public hospital services.

次要结局

  • Expected and Unexpected Societal Costs(At the completion of respective chemotherapy regimen, up to 6 months)

研究者

发起方
Vivian Wing Yan Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vivian Wing Yan Lee

Associate Professor

Chinese University of Hong Kong

研究点 (1)

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