Clinical trial NCT01679054: Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong
Official title: Cost-minimization Analysis of Xeloda® vs 5-fluorouracil-based Treatment for Gastric Cancer Patients in Hong Kong
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Neoplasm
Gastric Cancer
Cost
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Princess Margaret Hospital, Hong Kong
name: Pamela Youde Nethersole Eastern Hospital
First posted: 2012-09-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CDARS data will be accessed at respective sites to identify patients with aGC who have completed either EOX or EOF regimens.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Expected and Unexpected Provider Costs
timeFrame: At the completion of respective chemotherapy regimen, up to 6 months
Secondary outcomes:
measure: Expected and Unexpected Societal Costs
timeFrame: At the completion of respective chemotherapy regimen, up to 6 months
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
Study officials:
References: