An observational study in Gastric Cancer, sponsored by Vivian Wing Yan Lee. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Vivian Wing Yan Lee · Observational
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.
2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's enrollment of 58 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Vivian Wing Yan Lee is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
CDARS data will be accessed at respective sites to identify patients with aGC who have completed either EOX or EOF regimens.
Exclusion Criteria:
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 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
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.
Time frame: At the completion of respective chemotherapy regimen, up to 6 months
Expected and Unexpected Societal Costs
Expected and unexpected societal costs (patient time, travel)
Time frame: At the completion of respective chemotherapy regimen, up to 6 months
| Milestone | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 |
|---|---|---|
| Started | 45 | 13 |
| Completed | 45 | 13 |
| Not completed | 0 | 0 |
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.
| HK$ | EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) |
|---|---|---|
| Expected Medication Cost | 2264.1 ± 354.5 | 522 ± 104.5 |
| Expected Laboratory Tests | 1135.7 ± 294.3 | 846 ± 200.2 |
| Expected Day ward/inpatient visits | 600 ± 0 | 9900 ± 0 |
| Expected X rays & Scans | 760.3 ± 361.2 | 846.9 ± 367.6 |
| Expected Outpatient visits | 1094.3 ± 263 | 864.8 ± 163.2 |
| Unexpected Medication Cost | 116.2 ± 255.4 | 112.3 ± 169.9 |
| Unexpected Emergency unit visit | 39.5 ± 74.3 | 85.8 ± 109.6 |
| Unexpected Hosptial Bed-days | 1531.4 ± 4607.9 | 2830.5 ± 4358.6 |
| Unexpected Laboratory Tests | 297 ± 256.9 | 497.5 ± 470.5 |
| Unexpected X rays & Scans | 211.8 ± 520.1 | 315.6 ± 785.5 |
| Unexpected Outpatient visits | 344.1 ± 251.3 | 404.7 ± 433.3 |
| Total Unexpected Cost/cycle | 2540.1 ± 5064.4 | 4246.4 ± 4875.1 |
| Total Unexpected Cost/patient | 13434.0 ± 26785.2 | 33546.6 ± 38250.8 |
| Total Cost/patient | 44397.1 ± 27105.7 | 135387.9 ± 39084.0 |
Expected and unexpected societal costs (patient time, travel)
| HK$ | Epirubicin + Oxaliplatin + Capecitabine (EOX) Group | FOLFOX4 |
|---|---|---|
| Expected Patient Time Cost | 544 ± 154.4 | 1013.1 ± 471.4 |
| Expected Patient Travel Cost | 402.7 ± 290.5 | 236.6 ± 118.5 |
| Expected Patient Treatment Cost | 3097.1 ± 468.1 | 2322.5 ± 267.7 |
| Total Expected Cost/Cycle | 4043.7 ± 707.7 | 3572.2 ± 354.9 |
| Total Expected Cost/Patient | 21386.7 ± 3742.7 | 28220.4 ± 2784.8 |
| Unexpected Patient Time Cost | 323.3 ± 489.2 | 306.3 ± 400.3 |
| Unexpected Patient Travel Cost | 106.2 ± 110.7 | 69.5 ± 63.5 |
| Unexpected Patient Treatment Cost | 84.6 ± 141.1 | 134.7 ± 137.6 |
| Total Unexpected Cost/Cycle | 514.1 ± 645 | 510.5 ± 538.1 |
| Total Cost/Patient | 2719.3 ± 3517 | 4033 ± 4221.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | 0/45 (0%) | 0/45 (0%) | 22/45 (48.9%) |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | 0/13 (0%) | 0/13 (0%) | 7/13 (53.8%) |
| Event | EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) |
|---|---|---|
| Nausea and VomitingGastrointestinal disorders | 22/45 | 7/13 |
| Age, Categorical(Participants) | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 12 | 52 |
| >=65 years | 5 | 1 | 6 |
| Age, Continuous(years) | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| Mean | 56.6 ± 10 | 56.5 ± 13.3 | 56.5 ± 12.1 |
| Sex: Female, Male(Participants) | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| Female | 19 | 5 | 24 |
| Male | 26 | 8 | 34 |
| Ethnicity (NIH/OMB)(Participants) | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 45 | 13 | 58 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| Hong Kong | 45 | 13 | 58 |
| ECOG Performance Scores < 2(Participants) | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| Count of participants | 42 | 10 | 52 |
| ECOG Performance Score >= 2(Participants) | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| Count of participants | 3 | 3 | 6 |
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vivian Wing Yan Lee