Cost-minimization Analysis of Gastric Cancer Treatments in Hong Kong

This study has been completed.
Sponsor:
Collaborators:
Roche Hong Kong
Princess Margaret Hospital Department of Pharmacy
Princess Margaret Hospital Department of Clinical Oncology
Pamela Youde Nethersole Eastern Hospital
Information provided by (Responsible Party):
Vivian Wing Yan Lee, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01679054
First received: August 31, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cost-minimization Analysis of Xeloda® vs 5-fluorouracil-based Treatment for Gastric Cancer Patients in Hong Kong

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Expected and unexpected provider costs [ Time Frame: At the completion of respective chemotherapy regimen ] [ Designated as safety issue: No ]
    Expected and unexpected provider costs (chemotherapy, hospital stay, lab tests, clinic visits, AE management, other drug costs)


Secondary Outcome Measures:
  • Expected and unexpected societal costs [ Time Frame: At the completion of respective chemotherapy regimen ] [ Designated as safety issue: No ]
    Expected and unexpected societal costs (patient time, travel)


Enrollment: 58
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
EOX
Epirubicin + Oxaliplatin + Capecitabine (EOX) Epirubicin 50 mg/m2 iv bolus d1 q3w x 8 cycles Oxaliplatin (Eloxatin) 130 mg/m2 iv over 2 hours d1 q3w x 8 cycles Capecitabine (Xeloda) 625 mg/m2 po bid x 6 months
FOLFOX4
FOLFOX4 Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and 2 5-FU 400 mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d 1 and d2 Oxaliplatin (Eloxatin) 85 mg/m2 iv d1 Q2w x 12 cycles

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679054

Locations
Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Sponsors and Collaborators
Vivian Wing Yan Lee
Roche Hong Kong
Princess Margaret Hospital Department of Pharmacy
Princess Margaret Hospital Department of Clinical Oncology
Pamela Youde Nethersole Eastern Hospital
  More Information

No publications provided

Responsible Party: Vivian Wing Yan Lee, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01679054     History of Changes
Other Study ID Numbers: Roche-TR116582, TR116582VLKZ001
Study First Received: August 31, 2012
Last Updated: August 31, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Neoplasm
Gastric Cancer
Cost

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 01, 2014