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| ID | Type | Description | Link |
|---|---|---|---|
| TR116582VLKZ001 | Other Identifier | CUHK |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
| Princess Margaret Hospital, Hong Kong | OTHER_GOV |
| Pamela Youde Nethersole Eastern Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Expected and Unexpected Provider Costs | 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. | At the completion of respective chemotherapy regimen, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expected and Unexpected Societal Costs | Expected and unexpected societal costs (patient time, travel) | At the completion of respective chemotherapy regimen, up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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CDARS data will be accessed at respective sites to identify patients with aGC who have completed either EOX or EOF regimens.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Kowloon | Hong Kong |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epirubicin + Oxaliplatin + Capecitabine (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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Epirubicin + Oxaliplatin + Capecitabine (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 |
| BG001 | FOLFOX4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Expected and Unexpected Provider Costs | 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. | Posted | Mean | Standard Deviation | HK$ | At the completion of respective chemotherapy regimen, up to 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | It consists of an intravenous bolus injection of epirubicin 50 mg/m2 and an intravenous infusion of oxaliplatin 130 mg/m2 over 2 hours on day 1 of every 3 week cycles, together with oral capecitabine tablets 625 mg/m2 twice daily for six months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment | For both groups, nausea and vomiting were the most commonly associated adverse events; hence the most frequently used medications were anti-emetic drugs. |
1. A total of 58 subjects were identified with only thirteen in the FOLFOX4 arm. The two groups were then arranged for comparison in an approximate 3:1 ratio (45 EOX and 13 FOLFOX4). More patients seem to have chosen EOX over FOLFOX4 to avoid the inpatient stay for the prolonged administration of FOLFOX4
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Lee | The Chinese University of Hong Kong | +85239438012 | vivianlee@cuhk.edu.hk |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
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| ECOG Performance Scores < 2 | Count of Participants | Participants |
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| ECOG Performance Score >= 2 | Count of Participants | Participants |
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| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) |
It consists of an intravenous infusion of oxaliplatin 85 mg/m2 over 2 hours on day 1, and an intravenous infusion of folinic acid (leucovorin) 200 mg/m2 over 2 hours on days 1 and 2. This is followed by an intravenous bolus injection of 5-FU 400 mg/m2 and then continuous intravenous infusion of 5-FU 600 mg/m2 over 22 hours every 2 weeks. |
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| Secondary | Expected and Unexpected Societal Costs | Expected and unexpected societal costs (patient time, travel) | Posted | Mean | Standard Deviation | HK$ | At the completion of respective chemotherapy regimen, up to 6 months |
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| 0 |
| 45 |
| 0 |
| 45 |
| 22 |
| 45 |
| EG001 | FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | It consists of an intravenous infusion of oxaliplatin 85 mg/m2 over 2 hours on day 1, and an intravenous infusion of folinic acid (leucovorin) 200 mg/m2 over 2 hours on days 1 and 2. This is followed by an intravenous bolus injection of 5-FU 400 mg/m2 and then continuous intravenous infusion of 5-FU 600 mg/m2 over 22 hours every 2 weeks. | 0 | 13 | 0 | 13 | 7 | 13 |
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| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| Expected Patient Treatment Cost |
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| Total Expected Cost/Cycle |
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| Total Expected Cost/Patient |
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| Unexpected Patient Time Cost |
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| Unexpected Patient Travel Cost |
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| Unexpected Patient Treatment Cost |
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| Total Unexpected Cost/Cycle |
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| Total Cost/Patient |
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