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


N/A
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

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


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

This is a retrospective cost-minimization study to be conducted in a public hospital in Hong
Kong. Sixty (60) gastric cancer patients will be identified from existing case records (30
who completed a Xeloda®-based regimen and 30 who completed a 5-FU-based regimen) in the
study sites. Baseline characteristics from both groups prior to chemotherapy, including
demographics, ECOG performance score, liver/renal function, metastases, and survival will be
obtained. Cost data will also be extracted from patient records.

Information to be collected include cost of hospital admission and length of stay,
outpatient visits, diagnostic tests and treatments, chemotherapy regimens, all other drug
therapy, adverse side effect management, travel, and patient time. Baseline characteristics
and costs will be compared. Descriptive statistics will be utilized and sensitivity
analysis will be performed to investigate the robustness of the cost model.


Inclusion Criteria:



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

Exclusion Criteria:

- Patients less than 18 years of age

- Patient who did not meet inclusion criteria

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Expected and unexpected provider costs

Outcome Description:

Expected and unexpected provider costs (chemotherapy, hospital stay, lab tests, clinic visits, AE management, other drug costs)

Outcome Time Frame:

At the completion of respective chemotherapy regimen

Safety Issue:

No

Authority:

Hong Kong: Ethics Committee

Study ID:

Roche-TR116582

NCT ID:

NCT01679054

Start Date:

October 2011

Completion Date:

July 2012

Related Keywords:

  • Gastric Cancer
  • Neoplasm
  • Gastric Cancer
  • Cost
  • Stomach Neoplasms

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