Gastric Cancer
Conditions
Keywords
Neoplasm, Gastric Cancer, Cost
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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Princess Margaret Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Vivian Wing Yan Lee
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expected and Unexpected Provider Costs | At the completion of respective chemotherapy regimen, up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expected and Unexpected Societal Costs | At the completion of respective chemotherapy regimen, up to 6 months | Expected and unexpected societal costs (patient time, travel) |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 45 |
| 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 | 13 |
| Total | 58 |
Baseline characteristics
| Characteristic | Epirubicin + Oxaliplatin + Capecitabine (EOX) | FOLFOX4 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 12 Participants | 52 Participants |
| Age, Continuous | 56.6 years STANDARD_DEVIATION 10 | 56.5 years STANDARD_DEVIATION 13.3 | 56.5 years STANDARD_DEVIATION 12.1 |
| ECOG Performance Score >= 2 | 3 Participants | 3 Participants | 6 Participants |
| ECOG Performance Scores < 2 | 42 Participants | 10 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 13 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Hong Kong | 45 Participants | 13 Participants | 58 Participants |
| Sex: Female, Male Female | 19 Participants | 5 Participants | 24 Participants |
| Sex: Female, Male Male | 26 Participants | 8 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 13 |
| other Total, other adverse events | 22 / 45 | 7 / 13 |
| serious Total, serious adverse events | 0 / 45 | 0 / 13 |
Outcome results
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.
Time frame: At the completion of respective chemotherapy regimen, up to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Unexpected Outpatient visits | 344.1 HK$ | Standard Deviation 251.3 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Expected Medication Cost | 2264.1 HK$ | Standard Deviation 354.5 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Expected Laboratory Tests | 1135.7 HK$ | Standard Deviation 294.3 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Expected Day ward/inpatient visits | 600 HK$ | Standard Deviation 0 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Expected X rays & Scans | 760.3 HK$ | Standard Deviation 361.2 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Expected Outpatient visits | 1094.3 HK$ | Standard Deviation 263 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Unexpected Medication Cost | 116.2 HK$ | Standard Deviation 255.4 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Unexpected Emergency unit visit | 39.5 HK$ | Standard Deviation 74.3 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Unexpected Hosptial Bed-days | 1531.4 HK$ | Standard Deviation 4607.9 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Unexpected Laboratory Tests | 297 HK$ | Standard Deviation 256.9 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Unexpected X rays & Scans | 211.8 HK$ | Standard Deviation 520.1 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Total Unexpected Cost/cycle | 2540.1 HK$ | Standard Deviation 5064.4 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Total Unexpected Cost/patient | 13434.0 HK$ | Standard Deviation 26785.2 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Provider Costs | Total Cost/patient | 44397.1 HK$ | Standard Deviation 27105.7 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Unexpected X rays & Scans | 315.6 HK$ | Standard Deviation 785.5 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Unexpected Outpatient visits | 404.7 HK$ | Standard Deviation 433.3 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Unexpected Emergency unit visit | 85.8 HK$ | Standard Deviation 109.6 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Expected Medication Cost | 522 HK$ | Standard Deviation 104.5 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Total Unexpected Cost/patient | 33546.6 HK$ | Standard Deviation 38250.8 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Expected Laboratory Tests | 846 HK$ | Standard Deviation 200.2 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Unexpected Hosptial Bed-days | 2830.5 HK$ | Standard Deviation 4358.6 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Expected Day ward/inpatient visits | 9900 HK$ | Standard Deviation 0 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Total Unexpected Cost/cycle | 4246.4 HK$ | Standard Deviation 4875.1 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Expected X rays & Scans | 846.9 HK$ | Standard Deviation 367.6 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Unexpected Laboratory Tests | 497.5 HK$ | Standard Deviation 470.5 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Expected Outpatient visits | 864.8 HK$ | Standard Deviation 163.2 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Total Cost/patient | 135387.9 HK$ | Standard Deviation 39084 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Provider Costs | Unexpected Medication Cost | 112.3 HK$ | Standard Deviation 169.9 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Total Expected Cost/Patient | 21386.7 HK$ | Standard Deviation 3742.7 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Expected Patient Time Cost | 544 HK$ | Standard Deviation 154.4 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Unexpected Patient Time Cost | 323.3 HK$ | Standard Deviation 489.2 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Expected Patient Treatment Cost | 3097.1 HK$ | Standard Deviation 468.1 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Unexpected Patient Travel Cost | 106.2 HK$ | Standard Deviation 110.7 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Unexpected Patient Treatment Cost | 84.6 HK$ | Standard Deviation 141.1 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Total Unexpected Cost/Cycle | 514.1 HK$ | Standard Deviation 645 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Total Expected Cost/Cycle | 4043.7 HK$ | Standard Deviation 707.7 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Total Cost/Patient | 2719.3 HK$ | Standard Deviation 3517 |
| EOX (Epirubicin, Oxaliplatin, Xeloda®- Capecitabine) | Expected and Unexpected Societal Costs | Expected Patient Travel Cost | 402.7 HK$ | Standard Deviation 290.5 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Total Cost/Patient | 4033 HK$ | Standard Deviation 4221.7 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Expected Patient Time Cost | 1013.1 HK$ | Standard Deviation 471.4 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Expected Patient Travel Cost | 236.6 HK$ | Standard Deviation 118.5 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Expected Patient Treatment Cost | 2322.5 HK$ | Standard Deviation 267.7 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Total Expected Cost/Cycle | 3572.2 HK$ | Standard Deviation 354.9 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Total Expected Cost/Patient | 28220.4 HK$ | Standard Deviation 2784.8 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Unexpected Patient Time Cost | 306.3 HK$ | Standard Deviation 400.3 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Unexpected Patient Travel Cost | 69.5 HK$ | Standard Deviation 63.5 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Total Unexpected Cost/Cycle | 510.5 HK$ | Standard Deviation 538.1 |
| FOLFOX4 (5-fluorouracil (5-FU), Leucovorin, Oxaliplatin) | Expected and Unexpected Societal Costs | Unexpected Patient Treatment Cost | 134.7 HK$ | Standard Deviation 137.6 |